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

According to the United States Supreme Court, the premarket notification process for medical devices does not preempt state law claims when the devices fail. In Medtronic v. Lohr (U.S., June 26, 1996), the Court determined that the 1978 device ammendments do not preclude state law suits over design defects. Medtronic involved a cardiac pacemaker, but the case is significant for all types of medical devices, including breast implants.

Concerned about the impact of Medtronic v. Lohr? Visit the Food and Drug Law Institute (FDLI) or Medtronic's page or their press release.

• 21 USC Sec. 360c. Classification of devices intended for human use
• 21 USC Sec. 360d. Performance standards
• 21 USC Sec. 360e. Premarket approval
• 21 USC Sec. 360f. Banned devices
• 21 USC Sec. 360g. Judicial review
• 21 USC Sec. 360h. Notification and other remedies
• 21 USC Sec. 360i. Records and reports on devices
• 21 USC Sec. 360j. General provisions respecting control of devices
• 21 USC Sec. 360k. State and local requirements respecting devices
• 21 USC Sec. 360l. Postmarket surveillance
• 42 USC Sec. 1395m. Special payment rules for particular items and services

• 21 CFR PART 805: CARDIAC PACEMAKER REGISTRY
  • Sec. 805.1. Scope
  • Sec. 805.3. Definitions
  • Sec. 805.10 Submission of information by physicians and providers
  • Sec. 805.20 How to submit information
  • Sec. 805.25 Confidentiality

• S. 1111, To amend title 35, United States Code, with respect to patents on biotechnological processes. Sponsored by: Sen Hatch; Official Title: A bill to amend title 35, United States Code, with respect to patents on biotechnological processes. Became Public Law 104-41; Signed by the President: 11/01/95.
• Medical Technology Bills: 105th Congress
• 1997 Congressional Record: Medical Technology
• 1997 Congressional Record: Breast Implants
• Search "Medical Technology"
  • AltaVista ~ Excite! ~ HotBot
• Search "Breast Implants"
  • AltaVista ~ Excite! ~ HotBot

• Medtronic v. Lohr (U.S., June 26, 1996) (1978 Medical Device Ammendments do not preempt state lawsuits alleging design defects)

• FDA News The latest news form the Food and Drug Administration.
• HCFA: Fraud & Home Medical Equipment
• HHS: FDA Approvals in 1996 Set New Records
• Medical Devices Agency Every day thousands of medical devices are used in the treatment and care of patients in the UK.
• Medicare: Home Oxygen Program Warrants Continued HCFA Attention. HEHS-98-17. 17 pp. plus 1 appendix (7 pp.) November 7, 1997.
• Medical Devices; Establishment of a Performance Standard for Electrode Lead Wires and Patient Cables, [Federal Register: May 9, 1997 (Volume 62, Number 90)] [Rules and Regulations] [Page 25477-25498]
• Medicare: Technology Assessment and Medical Coverage Decisions (Fact Sheet, 07/20/94, GAO/HEHS-94-195FS). Thousands of medical procedures, devices, and drugs are available for patient care in this country. Each year, public and private health care insurers make coverage decisions for these medical technologies.
• Medicare: Excessive Payments for Medical Supplies Continue Despite Improvements (Letter Report, 08/08/95, GAO/HEHS-95-171). In fiscal year 1994 alone, Medicare was billed over $6.8 billion for medical supplies.
• Durable Medical Equipment: Regional Carriers' Coverage Criteria Are Consistent with Medicare Law (Letter Report, 09/19/95, GAO/HEHS-95-185). In November 1993, the Health Care Financing Administration began consolidating the work of processing and paying claims for durable medical equipment, prostheses, orthoses, and supplies at four regional carriers. Claims for such items had previously been processed and paid by local Medicare carriers.
• Fraud and Abuse: Providers Target Medicare Patients in Nursing Facilities (Letter Report, 01/24/96, GAO/HEHS-96-18). Pursuant to a congressional request, GAO reviewed allegations of fraud and abuse related to services and supplies provided to nursing facility patients.
• FDA Laboratories: Magnitude of Benefits Associated With Consolidation Is Questionable (Letter Report, 03/19/96, GAO/HEHS-96-30). Pursuant to a congressional request, GAO reviewed the Food and Drug Administration's (FDA) plan to consolidate its Office of Regulatory Affairs' (ORA) 18 field laboratories for product testing.
• Medical Device Regulation: Too Early to Assess European System's Value as Model for FDA (Letter Report, 03/06/96, GAO/HEHS-96-65). Pursuant to a congressional request, GAO compared the Food and Drug Administration's (FDA) and the European Union's (EU) systems for reviewing and approving medical devices.
• Medical Device Reporting: Improvements Needed in FDA's System for Monitoring Problems With Approved Devices (Letter Report, 01/29/97, GAO/HEHS-97-21). Pursuant to a legislative requirement, GAO reviewed user facilities' compliance with the Safe Medical Devices Act of 1990's (SMDA 90) reporting requirements.
• Medical Devices: FDA Review Time (Letter Report, 10/30/95, GAO/PEMD-96-2). Pursuant to a congressional request, GAO reviewed the Food and Drug Administration's (FDA) review of medical devices, focusing on how FDA review time has changed from fiscal year 1989 to May 18, 1995.
• Medicare: Excessive Payments for Medical Supplies Continue Despite Improvements (Testimony, 10/02/95, GAO/T-HEHS-96-5). GAO discussed Medicare payments for medical supplies.

• A Status Report on Breast Implant Safety Recently published studies have shown that women with silicone gel-filled breast implants do not have a greatly increased risk of some well-defined autoimmune diseases.
• Breast Implant Imaging Imges from the Frederik Philips Magnetic Resonance Research Center (FPMRRC).
• Breast Implants and Breast Cancer Risk In one study (ICDB/95609474), levels of potential carcinogens, toluenediamines (TDA), found following implantation of polyurethane-covered breast prostheses into operated breast cancer patients were monitored in blood, urine and drainage.
• Breast Reconstruction Trials using Saline-Filled Implants Information is available in PDQ concerning two clinical trials using saline- filled implants for breast reconstruction.
• Bröstimplantat - silikon - några referenser Slicone breast implants - selected references.
• Coalition of Silicone Survivors The Coalition of Silicone Survivors is an organization with over 4000 members world wide with many local groups providing support and information for those affected in any way by implants.
• Doctor's Guide: Studies Cast Doubt on Link Between Silicone Implants andRheumatic Disease Women with silicone breast implants have no higher risk of developing fibromyalgia or rheumatoid arthritis, nor any significant increase in antibodies in their blood.
• FDA Advises Doctors to Provide Risk Information on Breast Implants The Food and Drug Administration today told doctors and breast implant manufacturers that they should advise patients who are considering breast implant surgery about the risks of having these products implanted.
• FRONTLINE: Breast Implants on Trial Links to resources for women, coporate information, legal information, medical information, and more.
• InterNet Bankruptcy Library - Dow Corning Corporation
• Library (CIC, General) - Silicone Breast Implants The Food and Drug Administration decided last April to allow the continued use of silicone gel-filled breast implants, but only under limited conditions.
• Lipo-Matrix, Inc. Clinical Trials (soy bean oil implants) Due to overwhelming reponse for volunteers for the clinical trials using the trilucant breast implants (soy bean oil implants) the trial has been fully accrued.
• New England Journal of Medicine
  • Complications Leading to Surgery
  • Breast Implantation -- The Quest for
  • Evaluating the health risks of breast implants
  • Evaluating the health risks of breast implants: the interplay of medical science, the
  • Breast implants and connective-tissue diseases
  • Still more on breast implants and connective-tissue diseases
  • Silicone breast implants and the risk of connective-tissue diseases and symptoms
  • Breast implants and breast cancer--reanalysis of a linkage study
  • More on breast implants and connective-tissue diseases
  • Editorials and Conflicts of Interest
• Panel Recommends Continues Limited Use of Breast Implants A federal advisory panel Thursday rejected an outright ban on the use of silicone gel breast implants, recommending instead that certain women be allowed to obtain them under carefully prescribed conditions.
• Women's Implant Information Network W.I.I.N. (The Women's Implant Information Network) is an organization of citizens concerned with the silicone gel breast implant issue.

American National Standards Institute ~ ASTM Home Page ~ Baxter International Inc. ~ BC Biotechnology Alliance ~ BioSpace: What's New ~ Biotechnology Industry Organization ~ BMEnet Biomedical Engineering Resource ~ CNIDR U.S. Patents Project ~ CDRH HOME PAGE ~ Health Services/Technology Assessment Text ~ Medical Products Guide ~ MEDMarket(TM) Healthcare Manufacturing Industry Index ~ MEDMarket(TM) Virtual Industrial Park ~ MMDMSA Update ~ NEWSPAGE: Medical Equipment, Devices & Supplies ~ NIST WWW - Home Page ~ PNL Medical Technology and Systems Initiative ~ Scientific Instrument Services ~ Sequitur Associates, Inc. ~ Surgical Depot ~ The World-Wide Web Virtual Library of Engineering ~ U.S. Products Liability Law