143 related articles for article (PubMed ID: 27437880)
1. The US Food and Drug Administration Premarket Approval Process and the 515 Program Initiative: View From a Panel Chair.
Page RL
JAMA Cardiol; 2016 May; 1(2):119-20. PubMed ID: 27437880
[No Abstract] [Full Text] [Related]
2. Transparency and Dermatologic Device Approval by the US Food and Drug Administration.
Ezaldein HH; Scott JF; Yin ES; Ventura A; DeRuyter NP; Leffell DJ
JAMA Dermatol; 2018 Mar; 154(3):273-280. PubMed ID: 29365020
[TBL] [Abstract][Full Text] [Related]
3. Premarket approval supplement pathway: do we know what we are getting?
Zheng SY; Redberg RF
Ann Intern Med; 2014 Jun; 160(11):798-9. PubMed ID: 24664113
[No Abstract] [Full Text] [Related]
4. Medtronic, Inc.; premarket approval of the Interstim Sacral Nerve Stimulation (SNS) System--FDA. Notice.
Fed Regist; 1998 Jan; 63(19):4457. PubMed ID: 10177327
[TBL] [Abstract][Full Text] [Related]
5. 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]
6. Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011.
Rathi VK; Krumholz HM; Masoudi FA; Ross JS
JAMA; 2015 Aug; 314(6):604-12. PubMed ID: 26262798
[TBL] [Abstract][Full Text] [Related]
7. The US Food and Drug Administration 515 Program Initiative: Addressing the Evidence Gap for Widely Used, High-Risk Cardiovascular Devices?
Rathi VK; Kesselheim AS; Ross JS
JAMA Cardiol; 2016 May; 1(2):117-8. PubMed ID: 27437879
[No Abstract] [Full Text] [Related]
8. Defending substantial equivalence: an argument for the continuing validity of the 510(k) premarket notification process.
Flaherty JM
Food Drug Law J; 2008; 63(4):901-27. PubMed ID: 19601388
[No Abstract] [Full Text] [Related]
9. Gastroenterology and urology devices; effective date of requirement for premarket approval of the implanted mechanical/hydraulic urinary continence device. Food and Drug Administration, HHS. Final rule.
Fed Regist; 2000 Sep; 65(187):57726-32. PubMed ID: 11503643
[TBL] [Abstract][Full Text] [Related]
10. Medical devices; exemptions from premarket notification; class II devices; vascular tunnelers. Food and Drug Administration, HHS. Final rule.
Fed Regist; 2000 Mar; 65(43):11466-7. PubMed ID: 11010650
[TBL] [Abstract][Full Text] [Related]
11. Effective date of requirement for premarket approval for cardiovascular permanent pacemaker electrode. Final rule.
Food and Drug Administration, HHS
Fed Regist; 2012 Jul; 77(130):39924-7. PubMed ID: 22792583
[TBL] [Abstract][Full Text] [Related]
12. Medical devices; exemptions from premarket notification and reserved devices; class I--FDA. Notice.
Fed Regist; 1998 Feb; 63(21):5387-93. PubMed ID: 10177333
[TBL] [Abstract][Full Text] [Related]
13. Medical devices; exemptions from premarket notification; surgical lamps--FDA. Notice.
Fed Regist; 1998 Dec; 63(233):67075-6. PubMed ID: 10338882
[TBL] [Abstract][Full Text] [Related]
14. Food and Drug Administration Efforts to Mitigate Contact Lens Discomfort.
Hampton D; Green JA; Robboy M; Eydelman M
Eye Contact Lens; 2017 Jan; 43(1):2-4. PubMed ID: 27941360
[TBL] [Abstract][Full Text] [Related]
15. Gastroenterology-urology devices; effective date of requirement for premarket approval of the penile inflatable implant. Food and Drug Administration, HHS. Final rule.
Fed Regist; 2000 Apr; 65(71):19650-8. PubMed ID: 11010632
[TBL] [Abstract][Full Text] [Related]
16. Medical device; exemption from premarket notification; class II devices; barium enema retention catheters and tips with or without a bag. Food and Drug Administration, HHS. Final rule.
Fed Regist; 2000 Dec; 65(237):76930-2. PubMed ID: 11503724
[TBL] [Abstract][Full Text] [Related]
17. Premarket approval and federal preemption of product liability claims in the wake of Medtronic, Inc. v. Lohr.
Jarcho DG
Food Drug Law J; 1996; 51(4):613-8. PubMed ID: 11797730
[No Abstract] [Full Text] [Related]
18. 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]
19. Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair. Final order.
Food and Drug Administration, HHS
Fed Regist; 2016 Jan; 81(2):363-70. PubMed ID: 26742183
[TBL] [Abstract][Full Text] [Related]
20. Medical Devices; Exemption From Premarket Notification; Class II Devices; Electric Positioning Chair. Final order.
Food and Drug Administration, HHS
Fed Regist; 2015 Nov; 80(224):72589-91. PubMed ID: 26595944
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
