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

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.