The lohr decision: FDA perspective and position

Food and Drug Law Journal

Volumn 52, Issue 1, 1997, Pages 7-11

  Porter, Margaret Jane ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; EQUIPMENT; FOOD AND DRUG ADMINISTRATION; HUMAN; INDUSTRY; JURISPRUDENCE; LEGAL ASPECT; LEGAL LIABILITY; SAFETY; STANDARD; UNITED STATES;

CONSUMER PRODUCT SAFETY; EQUIPMENT SAFETY; HUMANS; INDUSTRY; JURISPRUDENCE; LIABILITY, LEGAL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0031292876     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (34)

1. 116 S. Ct. 2240(1996).
2. Pub. L. No. 75-717, §521, 52 Slat. 1040 (1938) (codified as amended 21 U.S.C. §360k (1994)).
3. Pub. L. No. 94-295, 90 Stat. 539 (codified as amended in scattered sections of 21 U.S.C.).
4. See 21 C.F.R. pt. 808 (1996).
5. Id. §808.l(d).
6. 21 C.F.R. S 801,420.
7. PDA Advisory Opinion to the National Women's Health Network, Dkt. No. 83A-0140/AP (Mar. 8, 1984).
8. Id.
9. Id.
10. 45 Fed. Reg. 67,321, 67,322 (Oct. 10, 1980).
11. H. REP. No. 94-853, at 45-46 (1976).
12. 505 U.S. 504(1992).
13. Pub. L. No. 89-72, 19 Stat. 282 (1965) (codified at 15 U.S.C. §§1331-41 (1994)).
14. Lohr, 116 S. Ct. at 2262; Cippulone. 505 U.S. at 521.
15. See, e.g., Moore v. Kimberly-Clarke Corp., 867 F.2d 243 (5th Cir. 1989) (regarding 21 C.F.R. § 801.430, regulation of menstrual tampons).
16. 63 F.3d 25 (1st Cir. 1995).
17. See Talbott v. Bard, Inc., 848 F. Supp. 287 (D. Mass. 1994).
18. Brief for the United States as Amicus Curiae at 13-14, Talbott v. Bard, Inc., 63 F.3d 25 (1st Cir. 1995).
19. Talbiitt, 63 F.3d at 26-17.
20. 65 F.3d 392 (4th Cir. 1995), vacated and remanded, 116 S. Ct. 2576 (1996).
21. See 21 U.S.C. §360(k) (FDCA §510(k)).
22. Brief for the U.S. Food and Drug Admin, as Amicus Curiae, Duvall v. Bristol-Myers Squibb Co., 65 F.3d 392 (4th Cir. 1995) (No. 94-1520).
23. Id. at 1720.
24. Duvall, 65 F. 3d at 401.
25. Brief for the United States as Amicus Curiae Supporting Respondents/Cross-Petitioners, Medtronic, Inc. v. Lohr, 116 S. Ct. 2240 (1996) Nos. 95-754, 95-886 (U.S. Mar. 13, 1996), 1996 WL 118035, at *13.
26. Id. at *6.
27. Id. at *21.
28. Lotir, 116 S. Ct. at 2252-53.
29. Id. at 2250.
30. Id. at 2252.
31. Id. at 2251.
32. Id. at 2254-55.
33. Id. at 2258.
34. Id. at 2255.