Food and drug administration regulation of blood bank software: The new regulatory landscape for blood establishments and their vendors

Transfusion

Volumn 38, Issue 1, 1998, Pages 86-89

  Weeda, D F ^a   O'Flaherty, N F ^a,b  

^a Olsson Frank and Weeda   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

BLOOD BANK; COMPUTER PROGRAM; FOOD AND DRUG ADMINISTRATION; GOOD MANUFACTURING PRACTICE; MARKETING; REVIEW;

EID: 0031951888     PISSN: 00411132     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.1537-2995.1998.38198141504.x     Document Type: Review

References (19)

1. Zoon, KC Letter to blood bank software developers/marketers. Rockville, MD: CBER, March 31, 1994.
2. Food, Drug, and Cosmetic Act. 21 USC § 301 et seq., as amended (1997).
3. Food, Drug, and Cosmetic Act. 21 USC § 321(h), as amended (1997).
4. Parkman, PD. Memorandum to blood establishments concerning FDA regulation of their computer systems. Rockville, MD: CBER, September 8, 1989.
5. 21 CFR 807, Subpart B.
6. 21 CFR 820.
7. 21 CFR 803.
8. 21 CFR 807, Subpart E and 814, respectively.
9. 21 CFR 801.
10. Draft guidance for the validation of blood establishment computer systems. Rockville, MD: CBER, September 28, 1993.
11. Guideline for quality assurance in blood establishments. Rockville, MD: CBER, July 11, 1995.
12. Draft review guidance for a premarket notification submission for blood establishment computer software. Rockville, MD: CBER, April 12, 1996.
13. Reviewer guidance for computer controlled medical devices under going 510(k) review. Rockville, MD: CDRH, August 29, 1991.
14. 21 CFR 807.81 (a) (3).
15. Deciding when to submit a new 510(k) for change to an existing device. Rockville, MD: CDRH, January 10, 1997.
16. 21 CFR 807.3(b) (1).
17. Draft policy for the regulation of computer products. Rockville, MD: CDRH, November 13, 1989.
18. Citizen Petition filed by Olsson, Frank and Weeda, PC, on behalf of the Association of Independent Blood Centers, Inc. FDA Docket No. 97P-0039/CP1, January 28, 1997.
19. Petition for a stay of action filed by Akin, Gump, Strauss, Hauer & Feld, LLP. FDA, Docket No. 96P-0087/PSA 1, March 7, 1996.