577 related articles for article (PubMed ID: 9800008)
1. FDA use of international standards in the premarket review process.
Rechen E; Barth DJ; Marlowe D; Kroger L
Biomed Instrum Technol; 1998; 32(5):518-26. PubMed ID: 9800008
[TBL] [Abstract][Full Text] [Related]
2. FDA recognition of consensus standards in the premarket notification program.
Marlowe DE; Phillips PJ
Biomed Instrum Technol; 1998; 32(3):301-4. PubMed ID: 9619259
[TBL] [Abstract][Full Text] [Related]
3. Safe Medical Devices Act: management guidance for hospital compliance with the new FDA requirements.
Alder HC
Hosp Technol Ser; 1993 Oct; 12(11):1-27. PubMed ID: 10129209
[TBL] [Abstract][Full Text] [Related]
4. Use and recognition of consensus standards in US premarket submissions.
Donawa ME
Med Device Technol; 1999 Mar; 10(2):13-7. PubMed ID: 10387610
[TBL] [Abstract][Full Text] [Related]
5. Medical devices; procedures for premarket notification, premarket approval, classification, performance standards establishment, banning devices, and availability of regulatory hearings--FDA. Final rule.
Fed Regist; 1992 Dec; 57(238):58400-6. PubMed ID: 10123143
[TBL] [Abstract][Full Text] [Related]
6. Human factors and the FDA's goals: improved medical device design.
Burlington DB
Biomed Instrum Technol; 1996; 30(2):107-9. PubMed ID: 8673158
[TBL] [Abstract][Full Text] [Related]
7. Delegations of authority and organization; Center for Devices and Radiological Health--FDA. Final rule.
Fed Regist; 1991 Oct; 56(197):51169-70. PubMed ID: 10115059
[TBL] [Abstract][Full Text] [Related]
8. Export of pharmaceuticals and medical devices under the federal Food, Drug & Cosmetic Act: FDA's striking change in interpretation post-Shelhigh.
Basile EM; Tolomeo D; Gluck E
Food Drug Law J; 2009; 64(1):149-69. PubMed ID: 19998744
[TBL] [Abstract][Full Text] [Related]
9. Legal regulation of the production and trade of medical devices and medical equipment in the EU and US: experience for Ukraine.
Pashkov V; Kotvitska A; Harkusha A
Wiad Lek; 2017; 70(3 pt 2):614-618. PubMed ID: 28713093
[TBL] [Abstract][Full Text] [Related]
10. The U.S. Food and Drug Administration's role in improving radiation dose management for medical X-ray imaging devices.
Miller DL; Kakar S; Jiang L; Spelic DC; Burk L
Br J Radiol; 2021 Oct; 94(1126):20210373. PubMed ID: 33989043
[TBL] [Abstract][Full Text] [Related]
11. New FDA draft guidance on premarket submissions.
Donawa ME
Med Device Technol; 1999 Oct; 10(8):12-4. PubMed ID: 10724773
[TBL] [Abstract][Full Text] [Related]
12. The need to certify products to CDRH Regulations.
Weiner R
J Laser Appl; 1994 Jun; 6(2):95-6. PubMed ID: 10160450
[TBL] [Abstract][Full Text] [Related]
13. Medical device regulation for manufacturers.
McAllister P; Jeswiet J
Proc Inst Mech Eng H; 2003; 217(6):459-67. PubMed ID: 14702983
[TBL] [Abstract][Full Text] [Related]
14. Use of standards in the review of medical devices.
Ho C; Jensen D; Lacy F; Muni N; Reilly S; Mallis E
J Electrocardiol; 2005 Oct; 38(4 Suppl):171-4. PubMed ID: 16226095
[TBL] [Abstract][Full Text] [Related]
15. What physicians should know about the regulation of Obstetric and Gynecologic Medical Devices.
Yin L
J Reprod Med; 1983 Jan; 28(1):3-11. PubMed ID: 6834344
[TBL] [Abstract][Full Text] [Related]
16. Designing medical devices for conformance with harmonized standards. The European Community's Medical Devices Directives and their effect on the product development process.
Fries RC; Graber MD
Biomed Instrum Technol; 1995; 29(4):284-92. PubMed ID: 7550495
[TBL] [Abstract][Full Text] [Related]
17. FDA Modernization Act of 1997: modifications to the list of recognized standards; availability; withdrawal of draft guidance "Use of IEC 60601 standards; medical electrical equipment"--FDA. Notice.
Fed Regist; 1998 Oct; 63(200):55617-30. PubMed ID: 10185835
[TBL] [Abstract][Full Text] [Related]
18. The "déjà vu effect:" evaluation of United States medical device legislation, regulation, and the Food and Drug Administration's contentious 510(k) program.
Bauman J
Food Drug Law J; 2012; 67(3):337-61, i. PubMed ID: 24624654
[TBL] [Abstract][Full Text] [Related]
19. FDA regulation of invasive neural recording electrodes: a daunting task for medical innovators.
Welle C; Krauthamer V
IEEE Pulse; 2012 Mar; 3(2):37-41. PubMed ID: 22481744
[TBL] [Abstract][Full Text] [Related]
20. FDA pilot programme in support of global harmonisation.
Donawa ME
Med Device Technol; 2003 Nov; 14(9):32-4. PubMed ID: 14682021
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
