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Publications
  • January–February 2021
  • Article
  • American Journal of Therapeutics

Food and Drug Administration Guidance Documents and New Medical Devices: The Case of Breast Prostheses

By: Rachel E. Weitzman, Ariel Dora Stern and Daniel B. Kramer
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Abstract

As pressure mounts on the Food and Drug Administration (FDA) to speed its review process for novel devices, and budgetary pressures further strain its resources, the critical role of guidance documents in assuring consistent, rigorous, and scientifically grounded review across device types has never been more important. In this article, we use the regulatory experience of one medical device class, specifically implantable breast prostheses, to illustrate the crucial role of FDA guidance documents. We find that the emergence of FDA guidance preceded significant growth of scientific publications around breast prostheses, with 0.30 +/- 0.57 papers/year published in the period 1987–2006 compared with 2.27 +/- 1.56 papers/year in the period 2007–2017, P=0.0017. This illustrates the importance of supporting the FDA to enhance guidance document drafting, revision, publication, and updating to reflect evolving scientific consensus and the needs of sponsors, regulators, and patients for transparent and consistent standards in a broad range of fields.

Keywords

Medical Devices; FDA; Health Care and Treatment; Government Administration; Information; Standards

Citation

Weitzman, Rachel E., Ariel Dora Stern, and Daniel B. Kramer. "Food and Drug Administration Guidance Documents and New Medical Devices: The Case of Breast Prostheses." American Journal of Therapeutics 28, no. 1 (January–February 2021).
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About The Author

Ariel D. Stern

Technology and Operations Management
→More Publications

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    Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance

    By: Alexander O. Everhart, Yi Zhu and Ariel D. Stern
More from the Authors
  • Hello Heart: The Next Generation of Chronic Disease Management Apps By: Ariel Dora Stern and Kumba Sennaar
  • Building the Business Case for an Inclusive Approach to Digital Health Measurement with a Web App (Market Opportunity Calculator): Instrument Development Study By: Mitchell Tang, Yashoda Sharma, Jennifer C. Goldsack and Ariel Dora Stern
  • Regulatory Submission Characteristics and Recalls of Medical Devices Receiving 510(k) Clearance By: Alexander O. Everhart, Yi Zhu and Ariel D. Stern
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