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Current Bladder Dysfunction Reports

Erschienen in:

22.06.2021 | Reconstructed Bladder Function & Dysfunction (M Kaufman, Section Editor)

Understanding the FDA Device Approval Process in FPMRS

verfasst von: Nathan Cheng, Debra Fromer

Erschienen in: Current Bladder Dysfunction Reports | Ausgabe 3/2021

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Abstract

Purpose of Review

This review will provide an understanding of the FDA device approval process, particularly with respect to medical devices used in female pelvic medicine and reconstructive surgery.

Recent Findings

Bringing a novel medical device to the market through the FDA regulatory process can be broken down into four steps: device classification, selecting and preparing premarket-submission regulatory pathways, FDA review of premarket-submissions, and postmarket regulatory controls.

Summary

While the FDA regulatory process can be daunting, physicians and surgeons have the responsibility toward unmet needs of patients and should be at the helm of medical device innovation.

Fox C, Fromer D. Trends in innovation in the surgical management of stress incontinence and pelvic organ prolapse: a “deep dive” into the FDA 510(k) and Premarket Approval Databases. American Urological Association National Meeting. (2020).

U.S. Food and Drug Administration. Center for Devices and Radiologic Health. Urogynecologic surgical mesh: update on the safety and effectiveness of transvaginal placement for pelvic organ prolapse. DC: Washington; 2011. www.fda.gov/media/81123/download

Obstetrical and Gynecological Devices; Reclassification of surgical mesh for transvaginal pelvic organ prolapse repair. 21 C.F.R. §884 (2016).

U.S. Food and Drug Administration. Center for Devices and Radiologic Health. FDA News Release: FDA takes action to protect women’s health, orders manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop selling all devices. DC: Washington; 2019. https://www.fda.gov/news-events/press-announcements/fda-takes-action-protect-womens-health-orders-manufacturers-surgical-mesh-intended-transvaginal

• U.S. Food and Drug Administration. How to Study and Market Your Device. https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/how-study-and-market-your-device, October 14, 2020. These sources provide the most real-world information on the regulatory process from the physician standpoint.

U.S. Food and Drug Administration. Center for Devices and Radiologic Health. Medical Device Classification Product Codes: Guidance for Industry and Food and Drug Administration Staff. DC: Washington; 2013. www.fda.gov/media/82781/download*

U.S. Food and Drug Administration. Regulatory Controls. https://www.fda.gov/medical-devices/overview-device-regulation/regulatory-controls, March 27, 2018

U.S. Food and Drug Administration. Pre Market Notification 510(k). https://www.fda.gov/medical-devices/premarket-submissions/premarket-notification-510k, March 13, 2020

U.S. Food and Drug Administration. De Novo Classification Request. https://www.fda.gov/medical-devices/premarket-submissions/de-novo-classification-request, November 20, 2019

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Premarket Approval of Medical Devices, 21 C.F.R § 814 (2020).

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U.S. Food and Drug Administration. Pre Market Approval. https://www.fda.gov/medical-devices/premarket-submissions/premarket-approval-pma, May 16, 2019

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U.S. Food and Drug Administration. Humanitarian device exemption. Sept 2019, https://www.fda.gov/medical-devices/premarket-submissions/humanitarian-device-exemption

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U.S. Food and Drug Administration. Reduced Medical Device User Fees: Small Business Determination (SBD) Program. https://www.fda.gov/medical-devices/premarket-submissions/reduced-medical-device-user-fees-small-business-determination-sbd-program

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United States Government Accountability Office. Report to the Ranking Member, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies, Committee on Appropriations, House of Representatives: Medical Devices: FDA Ordered Postmarket Studies to Better Understand Safety Issues, and Many Studies Are Ongoing. GAO-15-815 https://www.gao.gov/assets/gao-15-815.pdf, Sept 2015.

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U.S. Food and Drug Administration. 522 Postmarket Surveillance Studies Database. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pss.cfm. Last updated March 29, 2021.

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Reynolds IS, Rising JP, Coukell AJ, et al. Assessing the safety and effectiveness of devices after US Food and Drug Administration approval: FDA-mandated postapproval studies. JAMA Intern Med. 2014;174:1773–9.CrossRef

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Wimmer NJ, Robbins S, Ssemaganda H, et al. Assessing the cost burden of United States FDA-mandated post-approval studies for medical devices. J Health Care Finance. 2016.

Titel: Understanding the FDA Device Approval Process in FPMRS
verfasst von: Nathan Cheng
Debra Fromer
Publikationsdatum: 22.06.2021
Verlag: Springer US
Erschienen in: Current Bladder Dysfunction Reports / Ausgabe 3/2021
Print ISSN: 1931-7212
Elektronische ISSN: 1931-7220
DOI: https://doi.org/10.1007/s11884-021-00630-7

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Abstract

Purpose of Review

Recent Findings

Summary

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