General Accounting Office. Report to the Congress of the United States: Federal regulation of medical devices—problems still to be overcome. Washington DC, Government Printing Office, 1983; ReissJB, BucciVA. Medical device regulation: A new age of frustration. Health Lawyer 1985, 2:1.
5.
21 U.S.C. §321(h) (1982).
6.
21 U.S.C. §360c(a)(1)(A) (1982), and Sections referred to therein.
7.
21 U.S.C. §360d (1982).
8.
21 U.S.C. §360c(a)(1)(c) (1982).
9.
21 U.S.C. §360c(f)(2)(4) (1982).
10.
21 U.S.C. §360c(f)(1) (1982).
11.
21 U.S.C. §360c(f)(1)(A)(ii) (1982).
12.
21 U.S.C. $360c(f)(2)(B)(i) (1982).
13.
21 U.S.C. §360j(b) (1982).
14.
21 U.S.C. §360j(g) (1982).
15.
21 U.S.C. §360j(1) (1982).
16.
21 U.S.C. §360e (1982).
17.
21 U.S.C. §360c(a) (2) (1982).
18.
KesslerDA, PapeSM, SundwallDN. The federal regulation of medical devices. N Engl J Med1987;317:357–366.
19.
SmithGW. Device premarket approval: Lessons from the drug approval experience. Food Drug Cosmet Law J1983;38:4–12.
20.
21 U.S.C. §360c(a) (3) (1982).
21.
21 U.S.C. §360e(c) (1982).
22.
JacobsJA. FDA premarket approval of new medical devices: Confidentiality of data. Food Drug Cosmet Law J1980;35:576–587.
23.
21 U.S.C. §360e(c) (1982).
24.
21 U.S.C. §360e(d) (2) (1982).
25.
21 U.S.C. §360e(b) (1982).
26.
KahanJS. Premarket approval versus premarket notification: Different routes to the same market. Food Drug Cosmet Law J1984;39:510–525.
27.
U.S. Food and Drug Administration. Premarket notification: 510(k) regulatory requirements for medical devices. Department of Health and Human Services, 1983.
28.
Guidelines on the Center for Devices and Radiological Health's premarket notification review program. Department of Health and Human Services, 1986.
29.
U.S.C. §§360j(g), 355(i) (1982).
30.
Medical devices: Procedures for investigational device exemptions. Fed Regist January 18, 1980;45:3732–3759.
31.
Protection for human subjects; informed consent; standards for institutional review boards for clinical investigations; and clinical investigations which may be reviewed through expedited review procedures. Fed Regist January 27, 1981;13:1–2.
32.
FDA: Potential harm is key to significant risk decisions. Devices Diag Letter1986;13:1–2.
33.
Guidelines for the emergency use of unapproved medical devices; availability. Fed Regist October 22, 1985;50:42866–42867.
34.
21 U.S.C. §331 (1982).
35.
42 U.S.C. §1295y(2)(1)(A) (1982).
36.
Health Care Financing Administration. Intermediary letters numbers 77-4 and 77-5. Medicare and Medicaid guide. Chicago: Commerce Clearing House, 1976:152.
37.
BucciVA, ReissJB. Technology assessment of medical devices under Medicare: Who should examine "safety and effectiveness?"Food Drug Cosmet Law J1985;40:445–455.
38.
21 U.S.C. §360e(d)(1)(A) (1982).
39.
PMA Criticisms Task Force Report. Rockville MD. FDA Center for Devices and Radiological Health, 1985.
40.
United States House of Representatives, Committee on Energy and Commerce, Subcommittee on Health and Environment. Hearings on Medical Device Amendment of 1976. Testimony of the Health Industry Manufacturers Association. Washington DC: Government Printing Office, February 24, 1984.
41.
United States House of Representatives, Committee on Energy and Commerce, Subcommittee on Oversight and Investigations. Medical device regulation: The FDA's neglected child. Washington DC: Government Printing Office, 1983.
42.
United States House of Representatives, Committee on Energy and Commerce, Subcommittee on Health and Environment. Hearings on medical device amendments of 1976: Testimony of Franklin A Curtis. Washington DC: Government Printing Office, February 24, 1984.
43.
Office of Device Evaluation, Center of Devices and Radiologic Health. Annual Report, fiscal 1985. Rockville MD: FDA, 1985.
44.
U.S. Food and Drug Administration. Payment for investigational products. Washington DC: Department of Health and Human Services, 1984.
45.
United States House of Representatives, Committee on Energy and Commerce, Subcommittee on Health and the Environment. Hearings on medical device amendments of 1976: Testimony of Mark Novitch. Washington DC: Government Printing Office, February 24, 1984.
46.
Guideline for preparing notices of availability on investigational devices; availability. Fed Regist April 4, 1986;51:11642–11643.
