Drugs, Devices, and the FDA: Part 2: An Overview of Approval Processes: FDA Approval of Medical Devices

JACC. Basic to Translational Science
Gail A Van Norman

Abstract

As with new drugs, the U.S. Food and Drug Administration's approval process is intended to provide consumers with assurance that, once it reaches the market place, a medical device is safe and effective in its intended use. Bringing a device to market takes an average of 3 to 7 years, compared with an average of 12 years for drugs. However, there are concerns that Food and Drug Administration processes may not be sufficient to meet the assurances of safety and efficacy as intended. This second part of a 2-part series reviews the basic steps in development and Food and Drug Administration approval of medical devices, and summarizes post-marketing processes for drugs and devices.

References

Jul 1, 2004·Circulation·Aaron V KaplanMartin B Leon
Jul 29, 2010·Foot & Ankle Specialist·J George DeVries, Gregory C Berlet
Aug 13, 2011·The New England Journal of Medicine·Gregory D Curfman, Rita F Redberg
Nov 10, 2011·JAMA : the Journal of the American Medical Association·Joseph P Broderick, Philip M Meyers
Aug 28, 2014·Plastic and Reconstructive Surgery·Nima NaghshinehJ Peter Rubin
Jun 4, 2015·The New England Journal of Medicine·Jerry Avorn, Aaron S Kesselheim

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Citations

Mar 26, 2019·Advanced Materials·Benjamin R Freedman, David J Mooney
Jun 25, 2019·Frontiers in Cardiovascular Medicine·Benjamin L ZhangFrederick J Schoen
Feb 23, 2020·Annual Review of Analytical Chemistry·Bryant C NelsonMatthias Roesslein
Sep 17, 2020·Advanced Healthcare Materials·Didier LetourneurAbhay Pandit
May 28, 2019·Frontiers in Bioengineering and Biotechnology·Benjamen T O'DonnellBruce A Bunnell
Jun 27, 2019·American Journal of Clinical Pathology·Jonathan R Genzen
Sep 25, 2019·Nature Reviews. Urology·Naşide MangirSheila MacNeil
Jul 7, 2020·International Journal of Technology Assessment in Health Care·Wan Qing WongKwong Ng
May 11, 2019·Nature Reviews. Neurology·Wendy Moyle
Mar 24, 2020·Nature Biomedical Engineering·Shiko M Ben-MenahemJörg Goldhahn
Nov 18, 2019·Current Diabetes Reports·Gonzalo J AcostaArchana Sadhu
Sep 29, 2020·Journal of Pharmaceutical Innovation·Anaida KadMadhu Khatri
Nov 7, 2019·Orphanet Journal of Rare Diseases·Mohua Chakraborty Choudhury, Gayatri Saberwal
Nov 19, 2020·Expert Review of Medical Devices·Sai SaranNamrata S Rao
Jan 10, 2021·Biomedicine & Pharmacotherapy = Biomédecine & Pharmacothérapie·Yujin Lee, Jaewook Yang
Nov 17, 2020·Biomaterials Science·Daniela Peneda PachecoPaola Petrini
Feb 21, 2021·Communications Biology·Samson AfewerkiAnderson Oliveira Lobo
Mar 4, 2021·Expert Review of Molecular Diagnostics·Steven C SchachterSally M McFall
Mar 13, 2021·Advanced Therapeutics·Carlisle R DeJuliusCraig L Duvall
Jul 2, 2019·Acta Pharmaceutica : a Quarterly Journal of Croatian Pharmaceutical Society and Slovenian Pharmaceutical Society, Dealing with All Branches of Pharmacy and Allied Sciences·Othman A Al HanbaliAbdul Hameed
May 30, 2021·American Journal of Health-system Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists·Amanda J Gerberich, Heather J Ipema
Jul 19, 2021·Journal of the American Pharmacists Association : JAPhA·Casey M KepczynskiMichael E Klepser
Aug 19, 2021·Health Marketing Quarterly·Savannah CampbellMelissa Clark
Feb 4, 2022·Nanomedicine·Gourvi KumariAbhimanyu Dev

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Methods Mentioned

BETA
PMA

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