FDA regulation of telemedicine devices

Food and Drug Law Journal

Volumn 52, Issue 4, 1997, Pages 517-523

  Reichertz, Peter S ^a   Levan Halpern, Naomi Joy ^a  

^a Arent Fox Kintner Plotkin and Kahn   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DEVICE; FOOD AND DRUG ADMINISTRATION; HEALTH CARE DELIVERY; INFORMATION PROCESSING; LEGAL ASPECT; MEDICAL TECHNOLOGY; QUALITY CONTROL; REVIEW; TELECOMMUNICATION; UNITED STATES;

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

EID: 2642688633     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (33)

1. CENTER FOR DEVICES AND RADIOLOGICAL HEALTH, FOOD AND DRUG ADMIN., TELEMEDICINE-RELATED ACTIVITIES (1996), available in .
2. Id.
3. See South Texas Drug-Resistant Tuberculosis Study Will Use Telemedicine Link to NIH Clinical Center, F-D-C REP. ("The Blue Sheet"), Sept. 4, 1996, at 11.
4. See, e.g., David B. Jack, Robot Surgeons: Never Mind the Cost, Feel the Quality, 348 LANCET 1160 (1996).
5. COUNCIL ON COMPETITIVENESS, HIGHWAY TO HEALTH: TRANSFORMING U.S. HEALTH CARE IN THE INFORMATION AGE vi (1996).
6. Food and Drug Admin., Safety and Standard, in NATIONAL TELECOMMUNICATIONS AND INFO. ADMIN., DBP'T OF COMMERCE, TELEMEDICINE REPORT TO CONGRESS 63 (1997).
7. Pub. L. No. 102-539, 106 Stat. 3547 (codified at 42 U.S.C. §§ 201, 263b (1994)).
8. See TELEMEDICINE-RELATED ACTIVITIES, supra note 1.
9. Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended 21 U.S.C. §§ 301 et seq. (1994)).
10. 21 U.S.C. § 321(h) (FDCA § 201(h)).
11. TELEMEDICINE-RELATED ACTIVITIES, supra note 1.
12. 21 C.F.R. § 807.65(c) (1996).
13. 59 Fed. Reg. 44,991 (Aug. 31, 1994).
14. Id. at 44,992.
15. TELEMEDICINE-RELATED ACTIVITIES, supra note 1.
16. TELEMEDICINE REPORT TO CONGRESS, supra note 6, at 65-66.
17. See Medical Device Software: Highest Level of FDA Regulation Will Be 510(k), M-D-D-I REP. ("The Gray Sheet"), Sept. 22, 1986, at 4-5
18. FOOD AND DRUG ADMIN., DRAFT FDA POLICY FOR THE REGULATION OF COMPUTER PRODUCTS (1989)
19. Id. at 3.
20. 61 Fed. Reg. 36,886, 36,887 (July 15, 1996).
21. Id.
22. Id.
23. See Industry and Washington Memos, M-D-D-I REP. ("The Gray Sheet"), Dec. 23, 1996, at I&W 4-5.
24. 61 Fed. Reg. at 36,886.
25. CENTER FOR DEVICES AND RADIOLOGICAL HEALTH, FOOD AND DRUG ADMIN., FDA REGULATION OF MEDICAL DEVICE SOFTWARE (1996).
26. Id.
27. TELEMEDICINE-RELATED ACTIVITIES, supra note 1.
28. See Center for Devices and Radiological Health, Food and Drug Admin., Meeting Summary: FDA CADx Open Public Workshop (Mar. 6, 1996) .
29. TELEMEDICINE-RELATED ACTIVITIES, supra note 1.
30. CDRH SOFTWARE TASK FORCE GROUP, FOOD AND DRUG ADMIN., DRAFT ODE GUIDANCE FOR THE CONTENT OF PREMARKET SUBMISSION FOR MEDICAL DEVICES CONTAINING SOFTWARE (1996).
31. See ODE Software Reviewers Guide to Return to Policy Based on Three Levels of Concern, M-D-D-I REP. ("The Gray Sheet"), Sept. 29, 1997, at I&W-3.
32. CENTER FOR DEVICES AND RADIOLOGICAL HEALTH, FOOD AND DRUG ADMIN., DRAFT GUIDANCE FOR INDUSTRY: GENERAL PRINCIPLES OF SOFTWARE VALIDATION (1997). This guidance document is intended to assist manufacturer with quality assurance processes, rather than premarket submission issues.
33. OFFICE OF DEVICE EVALUATION, FOOD AND DRUG ADMIN., DRAFT GUIDANCE FOR OFF-THE-SHELF SOFTWARE USE IN MEDICAL DEVICES (1997).