Food and drug administration Act of 1997: Medical device provisions

Food and Drug Law Journal

Volumn 53, Issue 2, 1998, Pages 267-295

  Pilot, Larry R ^a   Waldmann, Daniel R ^a  

^a LLP   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DEVICE; FOOD AND DRUG ADMINISTRATION; LAW; REVIEW;

EQUIPMENT AND SUPPLIES; EQUIPMENT SAFETY; HUMANS; LEGISLATION, MEDICAL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0031814080     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (59)

1. See 21 U.S.C.A. §§ 301-397 (West Supp. 1998).
2. Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. §§ 301 et seq. (1994)).
3. S. 5, 75th Cong., 3d Sess. (1938).
4. Pub. L. No. 59-384, 34 Stat. 768 (codified at 21 U.S.C. §§ 1-15 (1934)) (repealed by 21 U.S.C. § 392(a)).
5. Pub. L. No. 105-115, 111 Stat. 2295 (1997).
6. See id. tit. I, 52 Stat. at 2298-332.
7. See id. tit. II, 52 Stat. at 2332-50.
8. See id. tit. III, 52 Stat. at 2350-56.
9. Id. § 406, 111 Stat. at 2369-70 (to be codified at 21 U.S.C. § 393(b),(f)-(g)).
10. S. REP. NO. 105-43, 105th Cong., 1st Sess. 2 (1997); H.R. REP. NO. 105-310, 105th Cong., 1st Sess. (1997).
11. Pub. L. No. 75-717, § 201(g), (h), 52 Stat. at 1401 (codified at 21 U.S.C. § 321(g), (h)).
12. Id. § 505, 52 Stat. at 1052-53 (codified at 21 U.S.C. § 355).
13. Id. § 501-502, 52 Stat. at 1049-51 (codified at 21 U.S.C. §§ 351-352).
14. Pub. L. No. 87-781, 76 Stat. 780 (1962).
15. See AMP Inc. v. Gardner, 389 F.2d 825 (2d Cir.), cert. denied, 393 U.S. 825 (1968); United States v. An Article of Drug ... Bacto-Unidisk, 394 U.S. 784 (1969).
16. DEPARTMENT OF HEALTH, EDUC., AND WELFARE, STUDY GROUP ON MED. DEVICES, MEDICAL DEVICES: A LEGISLATIVE PLAN (1970) [hereinafter Cooper Committee Report].
17. Id.
18. Pub. L. No. 94-295, 90 Stat. 539 (1976) (codified as amended in scattered sections of 21 U.S.C.)
19. The study group agreed that "[T]here are inherent differences between drugs and devices - differences in the state of the art, and the size and scope of manufacture." It believed "that a new regulatory plan is needed, one which is specifically adapted to the needs of devices." Cooper Committee Report, supra note 16, at 10. Although 17 specific recommendations were identified to accomplish the general aims described above, the study group identified the following three issues as central to the development of a sound legislative proposal: (1) An immediate, systematic review of the devices available and in use by an appropriately constituted group broadly representative of the concerned scientific community for the purpose of grouping medical devices into three categories - those that should be exempt from standard-setting and pre-market review, those for which standards should be set and enforced to assure safety and reliability, and those requiring pre-market review; (2) Delineation of an acceptable plan for assuring expert scientific review of the safety and effectiveness of medical devices at the clinical application phase, and prior to marketing; (3) Definition of the Federal government's role in establishment and surveillance of compliance with standards. Id. at 3.
20. FDAMA now provides for use of statutory advisory committees to assist the FDA on matters relating to scientific review of drugs. Pub. L. No. 105-115, § 210, 111 Stat. at 2342-45 (to be codified at 21 U.S.C. § 360m).
21. Among the regulations promulgated between 1976 and 1980 were those relating to IDE, GMP, PMN, registration, listing, banned devices, classification, and administrative detention of devices.
22. See FDA's Generic Drug Approval Process (Parts 1-3): Hearings Before the Subcomm. on Oversight and Investigations of the House Comm. on Energy and Commerce, 101st Cong., 1st Sess. (1989). Numerous incidents of criminal conduct involving FDA employees and abbreviated new drug approval applicants were uncovered and subsequent criminal prosecutions followed.
23. Pub. L. No. 101-629, 104 Stat. 4511 (codified in scattered sections of 21 U.S.C. and 42 U.S.C. § 263).
24. Medical Device Amendments of 1992, Pub. L. No. 102-300, 106 Stat. 238 (codified in scattered sections of 21 U.S.C. and 42 U.S.C. § 262).
25. H.R. REP. NO. 103-N, 103d Cong., 1st Sess. 5 (1993).
26. H.R. 4864, 103d Cong., 2d Sess. (1994).
27. See, e.g., Medical Device User Fees: Hearing Before the Health and Environment Subcomm. of the House Comm. on Energy and Commerce, 103d Cong., 2d Sess. (1994) (statement of Wayne K. Barlow, Chairman, Utah Biomed. Indus. Council); Letter from Daniel R. Patrick, D.D.S., Pres., Dental Implant Mfrs. Ass'n, to Rep. Thomas J. Bliley, Jr. (Aug. 4, 1994); Letter from John F. Mancini, Exec. Vice Pres., Am. Elec. Ass'n, to Rep. Henry Waxman (Aug. 4, 1994); Medical Device Mfrs. Ass'n, MDMA Continues Opposition to Current Use Fee (Tax) Legislation (July 20, 1994) (press release). See also MEDICAL DEVICE MFRS. ASS'N, DO LESS BETTER (1994).
28. See, e.g., Medical Device User Fees: Hearing Before the Health and Environment Subcomm. of the House Comm. on Energy and Commerce, 103d Cong., 2d Sess. (1994) (statement of Wayne K. Barlow, Chairman, Utah Biomed. Indus. Council); Letter from Daniel R. Patrick, D.D.S., Pres., Dental Implant Mfrs. Ass'n, to Rep. Thomas J. Bliley, Jr. (Aug. 4, 1994); Letter from John F. Mancini, Exec. Vice Pres., Am. Elec. Ass'n, to Rep. Henry Waxman (Aug. 4, 1994); Medical Device Mfrs. Ass'n, MDMA Continues Opposition to Current Use Fee (Tax) Legislation (July 20, 1994) (press release). See also MEDICAL DEVICE MFRS. ASS'N, DO LESS BETTER (1994).
29. See WILKERSON GROUP, INC., FORCES RESHAPING THE PERFORMANCE AND CONTRIBUTION OF THE MEDICAL DEVICE INDUSTRY (1995) (special report prepared for the Health Industry Mfrs. Ass'n).
30. See John Schwartz, Cardiopump: Overregulated or Overrated? Opinions Divided on Reasons for Medical Device Not Being Approved for Use in U.S., WASH. POST, Dec. 11, 1994, at A19.
31. PROGRESS AND FREEDOM FOUND., ADVANCING MEDICAL INNOVATION; HEALTH, SAFETY AND THE ROLE OF GOVERNMENT IN THE 21ST CENTURY (1996).
32. NATIONAL PERFORMANCE REVIEW, REINVENTING REGULATION OF DRUGS AND MEDICAL DEVICES (1995), available at Food and Drug Admin., Reinventing Drug and Device Regulations (visited May 14, 1998) 〈http:// www.fda.gov/po/reinvent.html〉.
33. NATIONAL PERFORMANCE REVIEW, REINVENTING REGULATION OF DRUGS AND MEDICAL DEVICES (1995), available at Food and Drug Admin., Reinventing Drug and Device Regulations (visited May 14, 1998) 〈http:// www.fda.gov/po/reinvent.html〉.
34. See, e.g., FDA Approval Process, Hearing Before the Subcomm. on Health and the Environ. of the House Comm. on Commerce, 104th Cong., 2d Sess. (May 1, 1996); Need for Changes at the FDA, Hearing Before the Subcomm. on Oversight and Investigations of the House Comm. on Commerce, 104th Cong., 2d Sess. (Feb. 27, 1996); More Information for Better Patient Care, Hearing Before the Senate Comm. on Labor and Human Resources, 104th Cong., 2d Sess. (Feb. 22, 1996); Revitalizing New Product Development: From Clinical Trials Through FDA Review, Hearing Before the Senate Comm. on Labor and Human Resources, 104th Cong., 2d Sess. (Feb. 21, 1996); Effect of Regulations on Medical Technology Development, Hearing Before the Subcomm. on Technology of the House Comm. on Science, 104th Cong., 1st Sess. (Nov. 2, 1995); Elderly Access to Advance Medical Technologies, Hearing Before the Subcomm. on Aging of the Senate Comm. on Labor and Human Resources, 104th Cong., 1st Sess. (July 13, 1995); FDA Approval of Drugs, Hearing Before the Subcomm. on Oversight and Investigations of the House Comm. on Commerce, 104th Cong., 1st Sess. (May 25, 1995); Reform of the Food and Drug Administration, Hearing Before the Senate Labor and Human Resources Comm., 104th Cong., 1st Sess. (Apr. 5, 1995).
35. See, e.g., FDA Approval Process, Hearing Before the Subcomm. on Health and the Environ. of the House Comm. on Commerce, 104th Cong., 2d Sess. (May 1, 1996); Need for Changes at the FDA, Hearing Before the Subcomm. on Oversight and Investigations of the House Comm. on Commerce, 104th Cong., 2d Sess. (Feb. 27, 1996); More Information for Better Patient Care, Hearing Before the Senate Comm. on Labor and Human Resources, 104th Cong., 2d Sess. (Feb. 22, 1996); Revitalizing New Product Development: From Clinical Trials Through FDA Review, Hearing Before the Senate Comm. on Labor and Human Resources, 104th Cong., 2d Sess. (Feb. 21, 1996); Effect of Regulations on Medical Technology Development, Hearing Before the Subcomm. on Technology of the House Comm. on Science, 104th Cong., 1st Sess. (Nov. 2, 1995); Elderly Access to Advance Medical Technologies, Hearing Before the Subcomm. on Aging of the Senate Comm. on Labor and Human Resources, 104th Cong., 1st Sess. (July 13, 1995); FDA Approval of Drugs, Hearing Before the Subcomm. on Oversight and Investigations of the House Comm. on Commerce, 104th Cong., 1st Sess. (May 25, 1995); Reform of the Food and Drug Administration, Hearing Before the Senate Labor and Human Resources Comm., 104th Cong., 1st Sess. (Apr. 5, 1995).
36. See, e.g., FDA Approval Process, Hearing Before the Subcomm. on Health and the Environ. of the House Comm. on Commerce, 104th Cong., 2d Sess. (May 1, 1996); Need for Changes at the FDA, Hearing Before the Subcomm. on Oversight and Investigations of the House Comm. on Commerce, 104th Cong., 2d Sess. (Feb. 27, 1996); More Information for Better Patient Care, Hearing Before the Senate Comm. on Labor and Human Resources, 104th Cong., 2d Sess. (Feb. 22, 1996); Revitalizing New Product Development: From Clinical Trials Through FDA Review, Hearing Before the Senate Comm. on Labor and Human Resources, 104th Cong., 2d Sess. (Feb. 21, 1996); Effect of Regulations on Medical Technology Development, Hearing Before the Subcomm. on Technology of the House Comm. on Science, 104th Cong., 1st Sess. (Nov. 2, 1995); Elderly Access to Advance Medical Technologies, Hearing Before the Subcomm. on Aging of the Senate Comm. on Labor and Human Resources, 104th Cong., 1st Sess. (July 13, 1995); FDA Approval of Drugs, Hearing Before the Subcomm. on Oversight and Investigations of the House Comm. on Commerce, 104th Cong., 1st Sess. (May 25, 1995); Reform of the Food and Drug Administration, Hearing Before the Senate Labor and Human Resources Comm., 104th Cong., 1st Sess. (Apr. 5, 1995).
37. See, e.g., FDA Approval Process, Hearing Before the Subcomm. on Health and the Environ. of the House Comm. on Commerce, 104th Cong., 2d Sess. (May 1, 1996); Need for Changes at the FDA, Hearing Before the Subcomm. on Oversight and Investigations of the House Comm. on Commerce, 104th Cong., 2d Sess. (Feb. 27, 1996); More Information for Better Patient Care, Hearing Before the Senate Comm. on Labor and Human Resources, 104th Cong., 2d Sess. (Feb. 22, 1996); Revitalizing New Product Development: From Clinical Trials Through FDA Review, Hearing Before the Senate Comm. on Labor and Human Resources, 104th Cong., 2d Sess. (Feb. 21, 1996); Effect of Regulations on Medical Technology Development, Hearing Before the Subcomm. on Technology of the House Comm. on Science, 104th Cong., 1st Sess. (Nov. 2, 1995); Elderly Access to Advance Medical Technologies, Hearing Before the Subcomm. on Aging of the Senate Comm. on Labor and Human Resources, 104th Cong., 1st Sess. (July 13, 1995); FDA Approval of Drugs, Hearing Before the Subcomm. on Oversight and Investigations of the House Comm. on Commerce, 104th Cong., 1st Sess. (May 25, 1995); Reform of the Food and Drug Administration, Hearing Before the Senate Labor and Human Resources Comm., 104th Cong., 1st Sess. (Apr. 5, 1995).
38. See, e.g., FDA Approval Process, Hearing Before the Subcomm. on Health and the Environ. of the House Comm. on Commerce, 104th Cong., 2d Sess. (May 1, 1996); Need for Changes at the FDA, Hearing Before the Subcomm. on Oversight and Investigations of the House Comm. on Commerce, 104th Cong., 2d Sess. (Feb. 27, 1996); More Information for Better Patient Care, Hearing Before the Senate Comm. on Labor and Human Resources, 104th Cong., 2d Sess. (Feb. 22, 1996); Revitalizing New Product Development: From Clinical Trials Through FDA Review, Hearing Before the Senate Comm. on Labor and Human Resources, 104th Cong., 2d Sess. (Feb. 21, 1996); Effect of Regulations on Medical Technology Development, Hearing Before the Subcomm. on Technology of the House Comm. on Science, 104th Cong., 1st Sess. (Nov. 2, 1995); Elderly Access to Advance Medical Technologies, Hearing Before the Subcomm. on Aging of the Senate Comm. on Labor and Human Resources, 104th Cong., 1st Sess. (July 13, 1995); FDA Approval of Drugs, Hearing Before the Subcomm. on Oversight and Investigations of the House Comm. on Commerce, 104th Cong., 1st Sess. (May 25, 1995); Reform of the Food and Drug Administration, Hearing Before the Senate Labor and Human Resources Comm., 104th Cong., 1st Sess. (Apr. 5, 1995).
39. See, e.g., FDA Approval Process, Hearing Before the Subcomm. on Health and the Environ. of the House Comm. on Commerce, 104th Cong., 2d Sess. (May 1, 1996); Need for Changes at the FDA, Hearing Before the Subcomm. on Oversight and Investigations of the House Comm. on Commerce, 104th Cong., 2d Sess. (Feb. 27, 1996); More Information for Better Patient Care, Hearing Before the Senate Comm. on Labor and Human Resources, 104th Cong., 2d Sess. (Feb. 22, 1996); Revitalizing New Product Development: From Clinical Trials Through FDA Review, Hearing Before the Senate Comm. on Labor and Human Resources, 104th Cong., 2d Sess. (Feb. 21, 1996); Effect of Regulations on Medical Technology Development, Hearing Before the Subcomm. on Technology of the House Comm. on Science, 104th Cong., 1st Sess. (Nov. 2, 1995); Elderly Access to Advance Medical Technologies, Hearing Before the Subcomm. on Aging of the Senate Comm. on Labor and Human Resources, 104th Cong., 1st Sess. (July 13, 1995); FDA Approval of Drugs, Hearing Before the Subcomm. on Oversight and Investigations of the House Comm. on Commerce, 104th Cong., 1st Sess. (May 25, 1995); Reform of the Food and Drug Administration, Hearing Before the Senate Labor and Human Resources Comm., 104th Cong., 1st Sess. (Apr. 5, 1995).
40. See, e.g., FDA Approval Process, Hearing Before the Subcomm. on Health and the Environ. of the House Comm. on Commerce, 104th Cong., 2d Sess. (May 1, 1996); Need for Changes at the FDA, Hearing Before the Subcomm. on Oversight and Investigations of the House Comm. on Commerce, 104th Cong., 2d Sess. (Feb. 27, 1996); More Information for Better Patient Care, Hearing Before the Senate Comm. on Labor and Human Resources, 104th Cong., 2d Sess. (Feb. 22, 1996); Revitalizing New Product Development: From Clinical Trials Through FDA Review, Hearing Before the Senate Comm. on Labor and Human Resources, 104th Cong., 2d Sess. (Feb. 21, 1996); Effect of Regulations on Medical Technology Development, Hearing Before the Subcomm. on Technology of the House Comm. on Science, 104th Cong., 1st Sess. (Nov. 2, 1995); Elderly Access to Advance Medical Technologies, Hearing Before the Subcomm. on Aging of the Senate Comm. on Labor and Human Resources, 104th Cong., 1st Sess. (July 13, 1995); FDA Approval of Drugs, Hearing Before the Subcomm. on Oversight and Investigations of the House Comm. on Commerce, 104th Cong., 1st Sess. (May 25, 1995); Reform of the Food and Drug Administration, Hearing Before the Senate Labor and Human Resources Comm., 104th Cong., 1st Sess. (Apr. 5, 1995).
41. See, e.g., FDA Approval Process, Hearing Before the Subcomm. on Health and the Environ. of the House Comm. on Commerce, 104th Cong., 2d Sess. (May 1, 1996); Need for Changes at the FDA, Hearing Before the Subcomm. on Oversight and Investigations of the House Comm. on Commerce, 104th Cong., 2d Sess. (Feb. 27, 1996); More Information for Better Patient Care, Hearing Before the Senate Comm. on Labor and Human Resources, 104th Cong., 2d Sess. (Feb. 22, 1996); Revitalizing New Product Development: From Clinical Trials Through FDA Review, Hearing Before the Senate Comm. on Labor and Human Resources, 104th Cong., 2d Sess. (Feb. 21, 1996); Effect of Regulations on Medical Technology Development, Hearing Before the Subcomm. on Technology of the House Comm. on Science, 104th Cong., 1st Sess. (Nov. 2, 1995); Elderly Access to Advance Medical Technologies, Hearing Before the Subcomm. on Aging of the Senate Comm. on Labor and Human Resources, 104th Cong., 1st Sess. (July 13, 1995); FDA Approval of Drugs, Hearing Before the Subcomm. on Oversight and Investigations of the House Comm. on Commerce, 104th Cong., 1st Sess. (May 25, 1995); Reform of the Food and Drug Administration, Hearing Before the Senate Labor and Human Resources Comm., 104th Cong., 1st Sess. (Apr. 5, 1995).
42. S. 1477, 104th Cong., 1st Sess. (1995).
43. H.R. 3201, 104th Cong., 2d Sess. (1996).
44. H.R. 3200, 104th Cong., 2d Sess. (1996).
45. H.R. 3199, 104th Cong., 2d Sess. (1996).
46. S. 1369, 104th Cong., 1st Sess. (1995).
47. H.R. 1742, 104th Cong., 1st Sess. (1995).
48. S. 1477, § 609; H.R. 3201, § 12.
49. Pub. L. No. 102-571, 106 Stat. 4491 (1992).
50. In the Senate, Democratic Senators Chris Dodd (D-CT), Barbara Mikulski (D-MD), and Paul Wellstone (D-MN) worked closely with their Republican colleagues on the Labor and Human Resources Committee to fashion bipartisan legislation. Their support severely weakened the efforts of Senator Ted Kennedy (D-MA), the ranking Democrat on the committee, to block the passage of FDAMA. In the House, the cooperative efforts of Representatives Joe Barton (R-TX) and Anna Eshoo (D-CA) to craft the medical device provisions were critical to the inclusion of many device reforms in the final legislation.
51. 61 Fed. Reg. 14,789 (Apr. 3, 1996).
52. Pub. L. No. 105-115, 111 Stat. at 2344 (to be codified at 21 U.S.C. § 360m(c)).
53. S. 1477, § 408.
54. Pub. L. No. § 205(c) (to be codified at 21 U.S.C. § 360e(d)(1)(A)).
55. Id. § 205(a), (b) (to be codified at 21 U.S.C. § 360c(a)(3)(C), (a)(3)(D)(ii), (i)(1)(C)-(D)).
56. See Cook Group COO Ferguson to Testify on Behalf of Device Industry, F-D-C REP. ("The Gray Sheet"), Apr. 7, 1997, at (discussing testimony of Sidney Wolfe, M.D., Research Dir., Public Citizen Health Research Group).
57. House FDA Reform Mark-Up Expected in Early September, F-D-C REP. ("The Gray Sheet"), July 28, 1997 at 5.
58. These documents can be obtained at Center for Devices and Radiological Health, Guidance Pertaining to the FDA Modernization Act of 1997 (visited May 14, 1998) 〈http://www.FDA.gov/cdrh/modact/ modguid.html〉 or from CDRH Facts on Demand (ph. 1-800-899-0381 or 1-301-827-0111).
59. Table represents original work of McKenna & Cuneo, based on general information from FDA re: FDAMA.