165 related articles for article (PubMed ID: 35699217)
21. Medical devices; substantial equivalence; 510(K) summaries and 510(K) statements; class III summaries; confidentiality of information--FDA. Final rule.
Fed Regist; 1994 Dec; 59(239):64287-96. PubMed ID: 10139433
[TBL] [Abstract][Full Text] [Related]
22. Medical devices; exemption from premarket notification and reserved devices; class I. Food and Drug Administration, HHS. Final rule.
Fed Regist; 2000 Jan; 65(10):2296-323. PubMed ID: 11010655
[TBL] [Abstract][Full Text] [Related]
23. Recalls of Moderate- and High-Risk Otolaryngologic Devices Approved by the US Food and Drug Administration, 2003-2019.
Talati IA; Parsa KM; Gao WZ
Otolaryngol Head Neck Surg; 2022 Nov; 167(5):832-838. PubMed ID: 35290135
[TBL] [Abstract][Full Text] [Related]
24. Regulatory issues relating to therapies for periodontal regeneration.
Singleton DG; Torres-Cabassa A
Ann Periodontol; 1997 Mar; 2(1):223-8. PubMed ID: 9151556
[TBL] [Abstract][Full Text] [Related]
25. Selective reporting in trials of high risk cardiovascular devices: cross sectional comparison between premarket approval summaries and published reports.
Chang L; Dhruva SS; Chu J; Bero LA; Redberg RF
BMJ; 2015 Jun; 350():h2613. PubMed ID: 26063311
[TBL] [Abstract][Full Text] [Related]
26. Medical devices; exemption from premarket notification and reserved devices; Class I--FDA. Proposed rule.
Fed Regist; 1998 Nov; 63(218):63222-53. PubMed ID: 10187398
[TBL] [Abstract][Full Text] [Related]
27. Medical devices; exemption from premarket notification; class II devices; wheelchair elevator. Final order.
Food and Drug Administration, HHS
Fed Regist; 2013 Mar; 78(42):14013-5. PubMed ID: 23476998
[TBL] [Abstract][Full Text] [Related]
28. Food and Drug Association Approval Process for Devices Used in Endovascular Treatment of Stroke.
Gangadhara S; Siddiqui A; Mokin M
Neurology; 2021 Nov; 97(20 Suppl 2):S194-S200. PubMed ID: 34785618
[TBL] [Abstract][Full Text] [Related]
29. Substantial Equivalence Premarket Review: the Right Approach for Most Medical Devices.
Shapiro JK
Food Drug Law J; 2014; 69(3):365-97, i. PubMed ID: 27382855
[TBL] [Abstract][Full Text] [Related]
30. FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012.
Rome BN; Kramer DB; Kesselheim AS
JAMA; 2014 Jan 22-29; 311(4):385-91. PubMed ID: 24449317
[TBL] [Abstract][Full Text] [Related]
31. Medical devices; exemption from premarket notification; class II devices; powered patient transport. Final order.
Food and Drug Administration, HHS
Fed Regist; 2013 Mar; 78(42):14015-7. PubMed ID: 23476999
[TBL] [Abstract][Full Text] [Related]
32. Time to publication of cost-effectiveness analyses for medical devices.
Everhart AO
Am J Manag Care; 2023 May; 29(5):265-268. PubMed ID: 37229785
[TBL] [Abstract][Full Text] [Related]
33. Orthopaedic Device Approval Through the Premarket Approval Process: A Financial Feasibility Analysis for a Single Center.
Yang BW; Iorio ML; Day CS
J Bone Joint Surg Am; 2017 Mar; 99(6):e26. PubMed ID: 28291189
[TBL] [Abstract][Full Text] [Related]
34. The Food and Drug Administration's (FDA's) 510(k) Process: A Systematic Review of 1000 Cases.
Shah P; Olavarria O; Dhanani N; Ciomperlik H; Mohr C; Bernardi K; Neela N; Coelho R; Ali Z; Prabhu A; Liang MK
Am J Med; 2023 Feb; 136(2):172-178.e14. PubMed ID: 36170936
[TBL] [Abstract][Full Text] [Related]
35. 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]
36. Approval process for devices and mesh for surgical treatment of pelvic organ prolapse and urinary incontinence.
Nygaard I
Clin Obstet Gynecol; 2013 Jun; 56(2):229-31. PubMed ID: 23632639
[TBL] [Abstract][Full Text] [Related]
37. Use of Recalled Devices in New Device Authorizations Under the US Food and Drug Administration's 510(k) Pathway and Risk of Subsequent Recalls.
Kadakia KT; Dhruva SS; Caraballo C; Ross JS; Krumholz HM
JAMA; 2023 Jan; 329(2):136-143. PubMed ID: 36625810
[TBL] [Abstract][Full Text] [Related]
38. 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]
39. The FDA and Ensuring Safety and Effectiveness of Devices, Biologics, and Technology.
Dubin JR; Ibad H; Cil A; Murray M
J Am Acad Orthop Surg; 2022 Jul; 30(14):658-667. PubMed ID: 35797679
[TBL] [Abstract][Full Text] [Related]
40. Clinical Evidence Supporting US Food and Drug Administration Premarket Approval of High-Risk Otolaryngologic Devices, 2000-2014.
Rathi VK; Wang B; Ross JS; Downing NS; Kesselheim AS; Gray ST
Otolaryngol Head Neck Surg; 2017 Feb; 156(2):285-288. PubMed ID: 28093943
[TBL] [Abstract][Full Text] [Related]
[Previous] [Next] [New Search]
