- SEC. 201. Investigational device exemptions
- SEC. 202. Special review for certain devices
- SEC. 203. Expanding humanitarian use of devices
- SEC. 204. Device standards
- SEC. 205. Scope of review; collaborative determinations of device data requirements
- SEC. 206. Premarket notification
- SEC. 207. Evaluation of automatic class III designation
- SEC. 208. Classification panels
- SEC. 209. Certainty of review timeframes; collaborative review process
- SEC. 210. Accreditation of persons for review of premarket notification reports
- SEC. 211. Device tracking
- SEC. 212. Postmarket surveillance
- SEC. 213. Reports
- SEC. 214. Practice of medicine
- SEC. 215. Noninvasive blood glucose meter
- SEC. 216. Use of data relating to premarket approval; product development protocol
- SEC. 217. Clarification of the number of required clinical investigations for approval
(a) IN GENERAL- Section 520(g) (21 U.S.C. 360j(g)) is amended by adding at the end the following: '(6)(A) Not later than 1 year after the date of the enactment of the Food and Drug Administration Modernization Act of 1997, the Secretary shall by regulation establish, with respect to a device for which an exemption under this subsection is in effect, procedures and conditions that, without requiring an additional approval of an application for an exemption or the approval of a supplement to such an application, permit--
'(i) developmental changes in the device (including manufacturing changes) that do not constitute a significant change in design or in basic principles of operation and that are made in response to information gathered during the course of an investigation; and
'(ii) changes or modifications to clinical protocols that do not affect-- '(I) the validity of data or information resulting from the completion of an approved protocol, or the relationship of likely patient risk to benefit relied upon to approve a protocol; '(II) the scientific soundness of an investigational plan submitted under paragraph (3)(A); or '(III) the rights, safety, or welfare of the human subjects involved in the investigation.
'(B) Regulations under subparagraph (A) shall provide that a change or modification described in such subparagraph may be made if--
'(i) the sponsor of the investigation determines, on the basis of credible information (as defined by the Secretary) that the applicable conditions under subparagraph (A) are met; and
'(ii) the sponsor submits to the Secretary, not later than 5 days after making the change or modification, a notice of the change or modification.
'(7)(A) In the case of a person intending to investigate the safety or effectiveness of a class III device or any implantable device, the Secretary shall ensure that the person has an opportunity, prior to submitting an application to the Secretary or to an institutional review committee, to submit to the Secretary, for review, an investigational plan (including a clinical protocol). If the applicant submits a written request for a meeting with the Secretary regarding such review, the Secretary shall, not later than 30 days after receiving the request, meet with the applicant for the purpose of reaching agreement regarding the investigational plan (including a clinical protocol). The written request shall include a detailed description of the device, a detailed description of the proposed conditions of use of the device, a proposed plan (including a clinical protocol) for determining whether there is a reasonable assurance of effectiveness, and, if available, information regarding the expected performance from the device.
'(B) Any agreement regarding the parameters of an investigational plan (including a clinical protocol) that is reached between the Secretary and a sponsor or applicant shall be reduced to writing and made part of the administrative record by the Secretary. Any such agreement shall not be changed, except--
'(i) with the written agreement of the sponsor or applicant; or
'(ii) pursuant to a decision, made in accordance with subparagraph (C) by the director of the office in which the device involved is reviewed, that a substantial scientific issue essential to determining the safety or effectiveness of the device involved has been identified.
'(C) A decision under subparagraph (B)(ii) by the director shall be in writing, and may be made only after the Secretary has provided to the sponsor or applicant an opportunity for a meeting at which the director and the sponsor or applicant are present and at which the director documents the scientific issue involved.'
(b) ACTION ON APPLICATION- Section 515(d)(1)(B) (21 U.S.C
360e(d)(1)(B)) is amended by adding at the end the following: '(iii) The Secretary shall accept and review statistically valid and reliable data and any other information from investigations conducted under the authority of regulations required by section 520(g) to make a determination of whether there is a reasonable assurance of safety and effectiveness of a device subject to a pending application under this section if--
'(I) the data or information is derived from investigations of an earlier version of the device, the device has been modified during or after the investigations (but prior to submission of an application under subsection (c)) and such a modification of the device does not constitute a significant change in the design or in the basic principles of operation of the device that would invalidate the data or information; or
'(II) the data or information relates to a device approved under this section, is available for use under this Act, and is relevant to the design and intended use of the device for which the application is pending.'
Section 515(d) (21 U.S.C. 360e(d)) is amended--
(1) by redesignating paragraph (3) as paragraph (4); and
(2) by adding at the end the following: '(5) In order to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions, the Secretary shall provide review priority for devices--
'(A) representing breakthrough technologies,
'(B) for which no approved alternatives exist,
'(C) which offer significant advantages over existing approved alternatives, or
'(D) the availability of which is in the best interest of the patients.'
Section 520(m) (21 U.S.C. 360j(m)) is amended--
(1) in paragraph (2), by adding after and below subparagraph (C) the following sentences: 'The request shall be in the form of an application submitted to the Secretary. Not later than 75 days after the date of the receipt of the application, the Secretary shall issue an order approving or denying the application.';
(2) in paragraph (4)-- (A) in subparagraph (B), by inserting after '(2)(A)' the following: ', unless a physician determines in an emergency situation that approval from a local institutional review committee can not be obtained in time to prevent serious harm or death to a patient'; and (B) by adding after and below subparagraph (B) the following: 'In a case described in subparagraph (B) in which a physician uses a device without an approval from an institutional review committee, the physician shall, after the use of the device, notify the chairperson of the local institutional review committee of such use. Such notification shall include the identification of the patient involved, the date on which the device was used, and the reason for the use.';
(3) by amending paragraph (5) to read as follows: '(5) The Secretary may require a person granted an exemption under paragraph (2) to demonstrate continued compliance with the requirements of this subsection if the Secretary believes such demonstration to be necessary to protect the public health or if the Secretary has reason to believe that the criteria for the exemption are no longer met.'; and
(4) by amending paragraph (6) to read as follows: '(6) The Secretary may suspend or withdraw an exemption from the effectiveness requirements of sections 514 and 515 for a humanitarian device only after providing notice and an opportunity for an informal hearing.'
(a) ALTERNATIVE PROCEDURE- Section 514 (21 U.S.C. 360d) is amended by adding at the end the following:
'RECOGNITION OF A STANDARD '(c)(1)(A) In addition to establishing a performance standard under this section, the Secretary shall, by publication in the Federal Register, recognize all or part of an appropriate standard established by a nationally or internationally recognized standard development organization for which a person may submit a declaration of conformity in order to meet a premarket submission requirement or other requirement under this Act to which such standard is applicable.
'(B) If a person elects to use a standard recognized by the Secretary under subparagraph (A) to meet the requirements described in such subparagraph, the person shall provide a declaration of conformity to the Secretary that certifies that the device is in conformity with such standard. A person may elect to use data, or information, other than data required by a standard recognized under subparagraph (A) to meet any requirement regarding devices under this Act.
'(2) The Secretary may withdraw such recognition of a standard through publication of a notice in the Federal Register if the Secretary determines that the standard is no longer appropriate for meeting a requirement regarding devices under this Act.
'(3)(A) Subject to subparagraph (B), the Secretary shall accept a declaration of conformity that a device is in conformity with a standard recognized under paragraph (1) unless the Secretary finds--
'(i) that the data or information submitted to support such declaration does not demonstrate that the device is in conformity with the standard identified in the declaration of conformity; or
'(ii) that the standard identified in the declaration of conformity is not applicable to the particular device under review.
'(B) The Secretary may request, at any time, the data or information relied on by the person to make a declaration of conformity with respect to a standard recognized under paragraph (1).
'(C) A person making a declaration of conformity with respect to a standard recognized under paragraph (1) shall maintain the data and information demonstrating conformity of the device to the standard for a period of two years after the date of the classification or approval of the device by the Secretary or a period equal to the expected design life of the device, whichever is longer.'
(b) SECTION 301- Section 301 (21 U.S.C. 331) is amended by adding at the end the following: '(x) The falsification of a declaration of conformity submitted under section 514(c) or the failure or refusal to provide data or information requested by the Secretary under paragraph (3) of such section.'
(c) SECTION 501- Section 501(e) (21 U.S.C. 351(e)) is amended--
(1) by striking '(e)' and inserting '(e)(1)'; and
(2) by inserting at the end the following: '(2) If it is declared to be, purports to be, or is represented as, a device that is in conformity with any standard recognized under section 514(c) unless such device is in all respects in conformity with such standard.'
(d) CONFORMING AMENDMENTS- Section 514(a) (21 U.S.C. 360d(a)) is amended--
(1) in paragraph (1), in the second sentence, by striking 'under this section' and inserting 'under subsection (b)';
(2) in paragraph (2), in the matter preceding subparagraph (A), by striking 'under this section' and inserting 'under subsection (b)';
(3) in paragraph (3), by striking 'under this section' and inserting 'under subsection (b)'; and
(4) in paragraph (4), in the matter preceding subparagraph (A), by striking 'this section' and inserting 'this subsection and subsection (b)'
(a) SECTION 513(a)- Section 513(a)(3) (21 U.S.C. 360c(a)(3)) is amended by adding at the end the following: '(C) In making a determination of a reasonable assurance of the effectiveness of a device for which an application under section 515 has been submitted, the Secretary shall consider whether the extent of data that otherwise would be required for approval of the application with respect to effectiveness can be reduced through reliance on postmarket controls.
'(D)(i) The Secretary, upon the written request of any person intending to submit an application under section 515, shall meet with such person to determine the type of valid scientific evidence (within the meaning of subparagraphs (A) and (B)) that will be necessary to demonstrate for purposes of approval of an application the effectiveness of a device for the conditions of use proposed by such person. The written request shall include a detailed description of the device, a detailed description of the proposed conditions of use of the device, a proposed plan for determining whether there is a reasonable assurance of effectiveness, and, if available, information regarding the expected performance from the device. Within 30 days after such meeting, the Secretary shall specify in writing the type of valid scientific evidence that will provide a reasonable assurance that a device is effective under the conditions of use proposed by such person.
'(ii) Any clinical data, including one or more well-controlled investigations, specified in writing by the Secretary for demonstrating a reasonable assurance of device effectiveness shall be specified as result of a determination by the Secretary that such data are necessary to establish device effectiveness. The Secretary shall consider, in consultation with the applicant, the least burdensome appropriate means of evaluating device effectiveness that would have a reasonable likelihood of resulting in approval.
'(iii) The determination of the Secretary with respect to the specification of valid scientific evidence under clauses (i) and (ii) shall be binding upon the Secretary, unless such determination by the Secretary could be contrary to the public health.'
(b) SECTION 513(i)- Section 513(i)(1) (21 U.S.C. 360c(i)(1)) is amended by adding at the end the following: '(C) To facilitate reviews of reports submitted to the Secretary under section 510(k), the Secretary shall consider the extent to which reliance on postmarket controls may expedite the classification of devices under subsection (f)(1) of this section.
'(D) Whenever the Secretary requests information to demonstrate that devices with differing technological characteristics are substantially equivalent, the Secretary shall only request information that is necessary to making substantial equivalence determinations. In making such request, the Secretary shall consider the least burdensome means of demonstrating substantial equivalence and request information accordingly.
'(E)(i) Any determination by the Secretary of the intended use of a device shall be based upon the proposed labeling submitted in a report for the device under section 510(k). However, when determining that a device can be found substantially equivalent to a legally marketed device, the director of the organizational unit responsible for regulating devices (in this subparagraph referred to as the 'Director') may require a statement in labeling that provides appropriate information regarding a use of the device not identified in the proposed labeling if, after providing an opportunity for consultation with the person who submitted such report, the Director determines and states in writing--
'(I) that there is a reasonable likelihood that the device will be used for an intended use not identified in the proposed labeling for the device; and
'(II) that such use could cause harm.
'(ii) Such determination shall--
'(I) be provided to the person who submitted the report within 10 days from the date of the notification of the Director's concerns regarding the proposed labeling;
'(II) specify the limitations on the use of the device not included in the proposed labeling; and
'(III) find the device substantially equivalent if the requirements of subparagraph (A) are met and if the labeling for such device conforms to the limitations specified in subclause (II).
'(iii) The responsibilities of the Director under this subparagraph may not be delegated.
'(iv) This subparagraph has no legal effect after the expiration of the five-year period beginning on the date of the enactment of the Food and Drug Administration Modernization Act of 1997.'
(c) SECTION 515(d)- Section 515(d) (21 U.S.C. 360e(d)) is amended--
(1) in paragraph (1)(A), by adding after and below clause (ii) the following: 'In making the determination whether to approve or deny the application, the Secretary shall rely on the conditions of use included in the proposed labeling as the basis for determining whether or not there is a reasonable assurance of safety and effectiveness, if the proposed labeling is neither false nor misleading. In determining whether or not such labeling is false or misleading, the Secretary shall fairly evaluate all material facts pertinent to the proposed labeling.'; and
(2) by adding after paragraph (5) (as added by section 202(2)) the following: '(6)(A)(i) A supplemental application shall be required for any change to a device subject to an approved application under this subsection that affects safety or effectiveness, unless such change is a modification in a manufacturing procedure or method of manufacturing and the holder of the approved application submits a written notice to the Secretary that describes in detail the change, summarizes the data or information supporting the change, and informs the Secretary that the change has been made under the requirements of section 520(f).
'(ii) The holder of an approved application who submits a notice under clause (i) with respect to a manufacturing change of a device may distribute the device 30 days after the date on which the Secretary receives the notice, unless the Secretary within such 30-day period notifies the holder that the notice is not adequate and describes such further information or action that is required for acceptance of such change. If the Secretary notifies the holder that a supplemental application is required, the Secretary shall review the supplement within 135 days after the receipt of the supplement. The time used by the Secretary to review the notice of the manufacturing change shall be deducted from the 135-day review period if the notice meets appropriate content requirements for premarket approval supplements.
'(B)(i) Subject to clause (ii), in reviewing a supplement to an approved application, for an incremental change to the design of a device that affects safety or effectiveness, the Secretary shall approve such supplement if--
'(I) nonclinical data demonstrate that the design modification creates the intended additional capacity, function, or performance of the device; and
'(II) clinical data from the approved application and any supplement to the approved application provide a reasonable assurance of safety and effectiveness for the changed device.
'(ii) The Secretary may require, when necessary, additional clinical data to evaluate the design modification of the device to provide a reasonable assurance of safety and effectiveness.'
(a) SECTION 510- Section 510 (21 U.S.C. 360) is amended--
(1) in subsection (k), in the matter preceding paragraph (1), by adding after 'report to the Secretary' the following: 'or person who is accredited under section 523(a)'; and
(2) by adding at the end the following subsections: '(l) A report under subsection (k) is not required for a device intended for human use that is exempted from the requirements of this subsection under subsection (m) or is within a type that has been classified into class I under section 513. The exception established in the preceding sentence does not apply to any class I device that is intended for a use which is of substantial importance in preventing impairment of human health, or to any class I device that presents a potential unreasonable risk of illness or injury.
'(m)(1) Not later than 60 days after the date of enactment of the Food and Drug Administration Modernization Act of 1997, the Secretary shall publish in the Federal Register a list of each type of class II device that does not require a report under subsection (k) to provide reasonable assurance of safety and effectiveness.
Each type of class II device identified by the Secretary as not requiring the report shall be exempt from the requirement to provide a report under subsection (k) as of the date of the publication of the list in the Federal Register.
'(2) Beginning on the date that is 1 day after the date of the publication of a list under this subsection, the Secretary may exempt a class II device from the requirement to submit a report under subsection (k), upon the Secretary's own initiative or a petition of an interested person, if the Secretary determines that such report is not necessary to assure the safety and effectiveness of the device. The Secretary shall publish in the Federal Register notice of the intent of the Secretary to exempt the device, or of the petition, and provide a 30-day period for public comment. Within 120 days after the issuance of the notice in the Federal Register, the Secretary shall publish an order in the Federal Register that sets forth the final determination of the Secretary regarding the exemption of the device that was the subject of the notice. If the Secretary fails to respond to a petition within 180 days of receiving it, the petition shall be deemed to be granted.'
(b) SECTION 513(f)- Section 513(f) (21 U.S.C. 360c(f)) is amended by adding at the end the following: '(5) The Secretary may not withhold a determination of the initial classification of a device under paragraph (1) because of a failure to comply with any provision of this Act unrelated to a substantial equivalence decision, including a finding that the facility in which the device is manufactured is not in compliance with good manufacturing requirements as set forth in regulations of the Secretary under section 520(f) (other than a finding that there is a substantial likelihood that the failure to comply with such regulations will potentially present a serious risk to human health).'
(c) SECTION 513(i)- Section 513(i)(1) (21 U.S.C. 360c(i)), as amended by section 205(b), is amended--
(1) in subparagraph (A)(ii)-- (A) in subclause (I), by striking 'clinical data' and inserting 'appropriate clinical or scientific data' and by inserting 'or a person accredited under section 523' after 'Secretary'; and (B) in subclause (II), by striking 'efficacy' and inserting 'effectiveness'; and
(2) by adding at the end the following: '(F) Not later than 270 days after the date of the enactment of the Food and Drug Administration Modernization Act of 1997, the Secretary shall issue guidance specifying the general principles that the Secretary will consider in determining when a specific intended use of a device is not reasonably included within a general use of such device for purposes of a determination of substantial equivalence under subsection (f) or section 520(l).'
Section 513(f) (21 U.S.C. 360c(f)), as amended by section 206(b), is amended--
(1) in paragraph (1)-- (A) in subparagraph (B), by striking 'paragraph (2)' and inserting 'paragraph (3)'; and (B) in the last sentence, by striking 'paragraph (2)' and inserting 'paragraph (2) or (3)';
(2) by redesignating paragraphs (2) and (3) as paragraphs (3) and (4), respectively; and
(3) by inserting after paragraph (1) the following: '(2)(A) Any person who submits a report under section 510(k) for a type of device that has not been previously classified under this Act, and that is classified into class III under paragraph (1), may request, within 30 days after receiving written notice of such a classification, the Secretary to classify the device under the criteria set forth in subparagraphs (A) through (C) of subsection (a)(1). The person may, in the request, recommend to the Secretary a classification for the device. Any such request shall describe the device and provide detailed information and reasons for the recommended classification.
'(B)(i) Not later than 60 days after the date of the submission of the request under subparagraph (A), the Secretary shall by written order classify the device involved. Such classification shall be the initial classification of the device for purposes of paragraph (1) and any device classified under this paragraph shall be a predicate device for determining substantial equivalence under paragraph (1).
'(ii) A device that remains in class III under this subparagraph shall be deemed to be adulterated within the meaning of section 501(f)(1)(B) until approved under section 515 or exempted from such approval under section 520(g).
'(C) Within 30 days after the issuance of an order classifying a device under this paragraph, the Secretary shall publish a notice in the Federal Register announcing such classification.'
Section 513(b) (21 U.S.C. 360c(b)) is amended by adding at the end the following: '(5) Classification panels covering each type of device shall be scheduled to meet at such times as may be appropriate for the Secretary to meet applicable statutory deadlines.
'(6)(A) Any person whose device is specifically the subject of review by a classification panel shall have--
'(i) the same access to data and information submitted to a classification panel (except for data and information that are not available for public disclosure under section 552 of title 5, United States Code) as the Secretary;
'(ii) the opportunity to submit, for review by a classification panel, information that is based on the data or information provided in the application submitted under section 515 by the person, which information shall be submitted to the Secretary for prompt transmittal to the classification panel; and
'(iii) the same opportunity as the Secretary to participate in meetings of the panel.
'(B) Any meetings of a classification panel shall provide adequate time for initial presentations and for response to any differing views by persons whose devices are specifically the subject of a classification panel review, and shall encourage free and open participation by all interested persons.
'(7) After receiving from a classification panel the conclusions and recommendations of the panel on a matter that the panel has reviewed, the Secretary shall review the conclusions and recommendations, shall make a final decision on the matter in accordance with section 515(d)(2), and shall notify the affected persons of the decision in writing and, if the decision differs from the conclusions and recommendations of the panel, shall include the reasons for the difference.
'(8) A classification panel under this subsection shall not be subject to the annual chartering and annual report requirements of the Federal Advisory Committee Act.'
(a) CERTAINTY OF REVIEW TIMEFRAMES- Section 510 (21 U.S.C. 360), as amended by section 206(a)(2), is amended by adding at the end the following subsection: '(n) The Secretary shall review the report required in subsection (k) and make a determination under section 513(f)(1) not later than 90 days after receiving the report.'
(b) COLLABORATIVE REVIEW PROCESS- Section 515(d) (21 U.S.C 360e(d)), as amended by section 202(1), is amended by inserting after paragraph (2) the following: '(3)(A)(i) The Secretary shall, upon the written request of an applicant, meet with the applicant, not later than 100 days after the receipt of an application that has been filed as complete under subsection (c), to discuss the review status of the application.
'(ii) The Secretary shall, in writing and prior to the meeting, provide to the applicant a description of any deficiencies in the application that, at that point, have been identified by the Secretary based on an interim review of the entire application and identify the information that is required to correct those deficiencies.
'(iii) The Secretary shall notify the applicant promptly of--
'(I) any additional deficiency identified in the application, or
'(II) any additional information required to achieve completion of the review and final action on the application, that was not described as a deficiency in the written description provided by the Secretary under clause (ii).
'(B) The Secretary and the applicant may, by mutual consent, establish a different schedule for a meeting required under this paragraph.
(a) IN GENERAL- Subchapter A of chapter V is amended by adding at the end the following:
'SEC. 523. ACCREDITED PERSONS
'(a) IN GENERAL-
'(1) REVIEW AND CLASSIFICATION OF DEVICES- Not later than 1 year after the date of the enactment of the Food and Drug Administration Modernization Act of 1997, the Secretary shall, subject to paragraph (3), accredit persons for the purpose of reviewing reports submitted under section 510(k) and making recommendations to the Secretary regarding the initial classification of devices under section 513(f)(1).
'(2) REQUIREMENTS REGARDING REVIEW- '(A) IN GENERAL- In making a recommendation to the Secretary under paragraph (1), an accredited person shall notify the Secretary in writing of the reasons for the recommendation.
'(B) TIME PERIOD FOR REVIEW- Not later than 30 days after the date on which the Secretary is notified under subparagraph (A) by an accredited person with respect to a recommendation of an initial classification of a device, the Secretary shall make a determination with respect to the initial classification.
'(C) SPECIAL RULE- The Secretary may change the initial classification under section 513(f)(1) that is recommended under paragraph (1) by an accredited person, and in such case shall provide to such person, and the person who submitted the report under section 510(k) for the device, a statement explaining in detail the reasons for the change.
'(3) CERTAIN DEVICES- '(A) IN GENERAL- An accredited person may not be used to perform a review of-- '(i) a class III device; '(ii) a class II device which is intended to be permanently implantable or life sustaining or life supporting; or '(iii) a class II device which requires clinical data in the report submitted under section 510(k) for the device, except that the number of class II devices to which the Secretary applies this clause for a year, less the number of such reports to which clauses (i) and (ii) apply, may not exceed 6 percent of the number that is equal to the total number of reports submitted to the Secretary under such section for such year less the number of such reports to which such clauses apply for such year.
'(B) ADJUSTMENT- In determining for a year the ratio described in subparagraph (A)(iii), the Secretary shall not include in the numerator class III devices that the Secretary reclassified into class II, and the Secretary shall include in the denominator class II devices for which reports under section 510(k) were not required to be submitted by reason of the operation of section 510(m).
'(b) ACCREDITATION-
'(1) PROGRAMS- The Secretary shall provide for such accreditation through programs administered by the Food and Drug Administration, other government agencies, or by other qualified nongovernment organizations.
'(2) ACCREDITATION- '(A) IN GENERAL- Not later than 180 days after the date of the enactment of the Food and Drug Administration Modernization Act of 1997, the Secretary shall establish and publish in the Federal Register criteria to accredit or deny accreditation to persons who request to perform the duties specified in subsection (a). The Secretary shall respond to a request for accreditation within 60 days of the receipt of the request. The accreditation of such person shall specify the particular activities under subsection (a) for which such person is accredited.
'(B) WITHDRAWAL OF ACCREDITATION- The Secretary may suspend or withdraw accreditation of any person accredited under this paragraph, after providing notice and an opportunity for an informal hearing, when such person is substantially not in compliance with the requirements of this section or poses a threat to public health or fails to act in a manner that is consistent with the purposes of this section.
'(C) PERFORMANCE AUDITING- To ensure that persons accredited under this section will continue to meet the standards of accreditation, the Secretary shall-- '(i) make onsite visits on a periodic basis to each accredited person to audit the performance of such person; and '(ii) take such additional measures as the Secretary determines to be appropriate.
'(D) ANNUAL REPORT- The Secretary shall include in the annual report required under section 903(g) the names of all accredited persons and the particular activities under subsection (a) for which each such person is accredited and the name of each accredited person whose accreditation has been withdrawn during the year.
'(3) QUALIFICATIONS- An accredited person shall, at a minimum, meet the following requirements: '(A) Such person may not be an employee of the Federal Government.
'(B) Such person shall be an independent organization which is not owned or controlled by a manufacturer, supplier, or vendor of devices and which has no organizational, material, or financial affiliation with such a manufacturer, supplier, or vendor.
'(C) Such person shall be a legally constituted entity permitted to conduct the activities for which it seeks accreditation.
'(D) Such person shall not engage in the design, manufacture, promotion, or sale of devices.
'(E) The operations of such person shall be in accordance with generally accepted professional and ethical business practices and shall agree in writing that as a minimum it will-- '(i) certify that reported information accurately reflects data reviewed; '(ii) limit work to that for which competence and capacity are available; '(iii) treat information received, records, reports, and recommendations as proprietary information; '(iv) promptly respond and attempt to resolve complaints regarding its activities for which it is accredited; and '(v) protect against the use, in carrying out subsection (a) with respect to a device, of any officer or employee of the person who has a financial conflict of interest regarding the device, and annually make available to the public disclosures of the extent to which the person, and the officers and employees of the person, have maintained compliance with requirements under this clause relating to financial conflicts of interest.
'(4) SELECTION OF ACCREDITED PERSONS- The Secretary shall provide each person who chooses to use an accredited person to receive a section 510(k) report a panel of at least two or more accredited persons from which the regulated person may select one for a specific regulatory function.
'(5) COMPENSATION OF ACCREDITED PERSONS- Compensation for an accredited person shall be determined by agreement between the accredited person and the person who engages the services of the accredited person, and shall be paid by the person who engages such services.
'(c) DURATION- The authority provided by this section terminates--
'(1) 5 years after the date on which the Secretary notifies Congress that at least 2 persons accredited under subsection (b) are available to review at least 60 percent of the submissions under section 510(k), or
'(2) 4 years after the date on which the Secretary notifies Congress that the Secretary has made a determination described in paragraph (2)(B) of subsection (a) for at least 35 percent of the devices that are subject to review under paragraph (1) of such subsection, whichever occurs first.'
(b) RECORDKEEPING- Section 704 (21 U.S.C. 374) is amended by adding at the end the following: '(f)(1) A person accredited under section 523 to review reports made under section 510(k) and make recommendations of initial classifications of devices to the Secretary shall maintain records documenting the training qualifications of the person and the employees of the person, the procedures used by the person for handling confidential information, the compensation arrangements made by the person, and the procedures used by the person to identify and avoid conflicts of interest. Upon the request of an officer or employee designated by the Secretary, the person shall permit the officer or employee, at all reasonable times, to have access to, to copy, and to verify, the records.
'(2) Within 15 days after the receipt of a written request from the Secretary to a person accredited under section 523 for copies of records described in paragraph (1), the person shall produce the copies of the records at the place designated by the Secretary.'
(c) CONFORMING AMENDMENT- Section 301 (21 U.S.C. 331), as amended by section 204(b), is amended by adding at the end the following: '(y) In the case of a drug, device, or food--
'(1) the submission of a report or recommendation by a person accredited under section 523 that is false or misleading in any material respect;
'(2) the disclosure by a person accredited under section 523 of confidential commercial information or any trade secret without the express written consent of the person who submitted such information or secret to such person; or
'(3) the receipt by a person accredited under section 523 of a bribe in any form or the doing of any corrupt act by such person associated with a responsibility delegated to such person under this Act.'
(d) REPORTS ON PROGRAM OF ACCREDITATION-
(1) COMPTROLLER GENERAL- (A) IMPLEMENTATION OF PROGRAM- Not later than 5 years after the date of the enactment of this Act, the Comptroller General of the United States shall submit to the Committee on Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate a report describing the extent to which the program of accreditation required by the amendment made by subsection (a) has been implemented.
(B) EVALUATION OF PROGRAM- Not later than 6 months prior to the date on which, pursuant to subsection (c) of section 523 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)), the authority provided under subsection (a) of such section will terminate, the Comptroller General shall submit to the Committee on Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate a report describing the use of accredited persons under such section 523, including an evaluation of the extent to which such use assisted the Secretary in carrying out the duties of the Secretary under such Act with respect to devices, and the extent to which such use promoted actions which are contrary to the purposes of such Act.
(2) INCLUSION OF CERTAIN DEVICES WITHIN PROGRAM- Not later than 3 years after the date of the enactment of this Act, the Secretary of Health and Human Services shall submit to the Committee on Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate a report providing a determination by the Secretary of whether, in the program of accreditation established pursuant to the amendment made by subsection (a), the limitation established in clause (iii) of section 523(a)(3)(A) of the Federal Food, Drug, and Cosmetic Act (relating to class II devices for which clinical data are required in reports under section 510(k)) should be removed.
Effective 90 days after the date of the enactment of this Act, section 519(e) (21 U.S.C. 360i(e)) is amended to read as follows:
'DEVICE TRACKING '(e)(1) The Secretary may by order require a manufacturer to adopt a method of tracking a class II or class III device--
'(A) the failure of which would be reasonably likely to have serious adverse health consequences; or
'(B) which is-- '(i) intended to be implanted in the human body for more than one year, or '(ii) a life sustaining or life supporting device used outside a device user facility
'(2) Any patient receiving a device subject to tracking under paragraph (1) may refuse to release, or refuse permission to release, the patient's name, address, social security number, or other identifying information for the purpose of tracking.'
Effective 90 days after the date of the enactment of this Act, section 522 (21 U.S.C. 360l) is amended to read as follows:
'POSTMARKET SURVEILLANCE 'SEC. 522. (a) IN GENERAL- The Secretary may by order require a manufacturer to conduct postmarket surveillance for any device of the manufacturer which is a class II or class III device the failure of which would be reasonably likely to have serious adverse health consequences or which is intended to be--
'(1) implanted in the human body for more than one year, or
'(2) a life sustaining or life supporting device used outside a device user facility
'(b) SURVEILLANCE APPROVAL- Each manufacturer required to conduct a surveillance of a device shall, within 30 days of receiving an order from the Secretary prescribing that the manufacturer is required under this section to conduct such surveillance, submit, for the approval of the Secretary, a plan for the required surveillance. The Secretary, within 60 days of the receipt of such plan, shall determine if the person designated to conduct the surveillance has appropriate qualifications and experience to undertake such surveillance and if the plan will result in the collection of useful data that can reveal unforeseen adverse events or other information necessary to protect the public health. The Secretary, in consultation with the manufacturer, may by order require a prospective surveillance period of up to 36 months. Any determination by the Secretary that a longer period is necessary shall be made by mutual agreement between the Secretary and the manufacturer or, if no agreement can be reached, after the completion of a dispute resolution process as described in section 562.'
(a) REPORTS- Section 519 (21 U.S.C. 360i) is amended--
(1) in subsection (a)-- (A) in the matter preceding paragraph (1), by striking 'manufacturer, importer, or distributor' and inserting 'manufacturer or importer'; (B) in paragraph (4), by striking 'manufacturer, importer, or distributor' and inserting 'manufacturer or importer'; (C) in paragraph (7), by adding 'and' after the semicolon at the end; (D) in paragraph (8)-- (i) by striking 'manufacturer, importer, or distributor' each place such term appears and inserting 'manufacturer or importer'; and (ii) by striking the semicolon at the end and inserting a period; (E) by striking paragraph (9); and (F) by inserting at the end the following sentence: 'The Secretary shall by regulation require distributors to keep records and make such records available to the Secretary upon request. Paragraphs (4) and (8) apply to distributors to the same extent and in the same manner as such paragraphs apply to manufacturers and importers.';
(2) by striking subsection (d); and
(3) in subsection (f), by striking ', importer, or distributor' each place it appears and inserting 'or importer'.
(b) REGISTRATION- Section 510(g) (21 U.S.C. 360(g)) is amended--
(1) by redesignating paragraph (4) as paragraph (5);
(2) by inserting after paragraph (3) the following:
'(4) any distributor who acts as a wholesale distributor of devices, and who does not manufacture, repackage, process, or relabel a device; or'; and
(3) by adding at the end the following flush sentence: 'In this subsection, the term 'wholesale distributor' means any person (other than the manufacturer or the initial importer) who distributes a device from the original place of manufacture to the person who makes the final delivery or sale of the device to the ultimate consumer or user.'
(c) DEVICE USER FACILITIES-
(1) IN GENERAL- Section 519(b) (21 U.S.C. 360i(b)) is amended-- (A) in paragraph (1)(C)-- (i) in the first sentence, by striking 'a semi-annual basis' and inserting 'an annual basis'; (ii) in the second sentence, by striking 'and July 1'; and (iii) by striking the matter after and below clause (iv); and (B) in paragraph (2)-- (i) in subparagraph (A), by inserting 'or' after the comma at the end; (ii) in subparagraph (B), by striking ', or' at the end and inserting a period; and (iii) by striking subparagraph (C)
(2) SENTINEL SYSTEM- Section 519(b) (21 U.S.C. 360i(b)) is amended-- (A) by redesignating paragraph (5) as paragraph (6); and (B) by inserting after paragraph (4) the following paragraph: '(5) With respect to device user facilities:
'(A) The Secretary shall by regulation plan and implement a program under which the Secretary limits user reporting under paragraphs (1) through (4) to a subset of user facilities that constitutes a representative profile of user reports for device deaths and serious illnesses or serious injuries.
'(B) During the period of planning the program under subparagraph (A), paragraphs (1) through (4) continue to apply.
'(C) During the period in which the Secretary is providing for a transition to the full implementation of the program, paragraphs (1) through (4) apply except to the extent that the Secretary determines otherwise.
'(D) On and after the date on which the program is fully implemented, paragraphs (1) through (4) do not apply to a user facility unless the facility is included in the subset referred to in subparagraph (A).
'(E) Not later than 2 years after the date of the enactment of the Food and Drug Administration Modernization Act of 1997, the Secretary shall submit to the Committee on Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the Senate, a report describing the plan developed by the Secretary under subparagraph (A) and the progress that has been made toward the implementation of the plan.'
Chapter IX is amended by adding at the end the following:
'SEC. 906. PRACTICE OF MEDICINE
'Nothing in this Act shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship. This section shall not limit any existing authority of the Secretary to establish and enforce restrictions on the sale or distribution, or in the labeling, of a device that are part of a determination of substantial equivalence, established as a condition of approval, or promulgated through regulations. Further, this section shall not change any existing prohibition on the promotion of unapproved uses of legally marketed devices.'
(a) FINDINGS- The Congress finds that--
(1) diabetes and its complications are a leading cause of death by disease in America;
(2) diabetes affects approximately 16,000,000 Americans and another 650,000 will be diagnosed in 1997;
(3) the total health care-related costs of diabetes total nearly $100,000,000,000 per year;
(4) diabetes is a disease that is managed and controlled on a daily basis by the patient;
(5) the failure to properly control and manage diabetes results in costly and often fatal complications including but not limited to blindness, coronary artery disease, and kidney failure;
(6) blood testing devices are a critical tool for the control and management of diabetes, and existing blood testing devices require repeated piercing of the skin;
(7) the pain associated with existing blood testing devices creates a disincentive for people with diabetes to test blood glucose levels, particularly children;
(8) a safe and effective noninvasive blood glucose meter would likely improve control and management of diabetes by increasing the number of tests conducted by people with diabetes, particularly children; and
(9) the Food and Drug Administration is responsible for reviewing all applications for new medical devices in the United States.
(b) SENSE OF CONGRESS- It is the sense of the Congress that the availability of a safe, effective, noninvasive blood glucose meter would greatly enhance the health and well-being of all people with diabetes across America and the world.
(a) USE OF DATA RELATING TO PREMARKET APPROVAL-
(1) IN GENERAL- Section 520(h)(4) (21 U.S.C. 360j(h)(4)) is amended to read as follows: '(4)(A) Any information contained in an application for premarket approval filed with the Secretary pursuant to section 515(c) (including information from clinical and preclinical tests or studies that demonstrate the safety and effectiveness of a device, but excluding descriptions of methods of manufacture and product composition and other trade secrets) shall be available, 6 years after the application has been approved by the Secretary, for use by the Secretary in--
'(i) approving another device;
'(ii) determining whether a product development protocol has been completed, under section 515 for another device;
'(iii) establishing a performance standard or special control under this Act; or
'(iv) classifying or reclassifying another device under section 513 and subsection (l)(2)
'(B) The publicly available detailed summaries of information respecting the safety and effectiveness of devices required by paragraph (1)(A) shall be available for use by the Secretary as the evidentiary basis for the agency actions described in subparagraph (A).'
(2) CONFORMING AMENDMENTS- Section 517(a) (21 U.S.C. 360g(a)) is amended-- (A) in paragraph (8), by adding 'or' at the end; (B) in paragraph (9), by striking ', or' and inserting a comma; and (C) by striking paragraph (10).
(b) PRODUCT DEVELOPMENT PROTOCOL- Section 515(f)(2) (21 U.S.C 360e(f)(2)) is amended by striking 'he shall' and all that follows and inserting the following: 'the Secretary--
'(A) may, at the initiative of the Secretary, refer the proposed protocol to the appropriate panel under section 513 for its recommendation respecting approval of the protocol; or
'(B) shall so refer such protocol upon the request of the submitter, unless the Secretary finds that the proposed protocol and accompanying data which would be reviewed by such panel substantially duplicate a product development protocol and accompanying data which have previously been reviewed by such a panel.'
Section 513(a)(3)(A) (21 U.S.C. 360c(a)(3)(A)) is amended by striking 'clinical investigations' and inserting '1 or more clinical investigations'.