Division of Clinical Research

Office of the Vice President and Innovation

12/20/2019 – Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff

The Food and Drug Administration (FDA) has developed this document to describe relevant information that should be included in test report summaries, test protocols and complete test reports for non-clinical bench performance testing provided in a premarket submission (i.e., premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, premarket notification (510(k)) submissions, investigational device exemption (IDE) applications, and De Novo requests).

Link: www.fda.gov/media/113230/download


12/18/2019 – Bridging for Drug-Device and Biologic-Device Combination Products: Draft Guidance for Industry [DRAFT]

This guidance provides recommendations to industry and FDA staff on how to approach bridging in new drug applications (NDAs) or biologics license applications (BLAs) for drug-device and biologic-device single entity or co-packaged combination products including the following:

  • Bridging of information related to a combination product that employs a different device constituent part or parts with the same drug constituent part or parts as the proposed combination product
  • Bridging of information related to a combination product that employs a different drug constituent part or parts with the same device constituent part or parts as the proposed combination product

Link: www.fda.gov/media/133676/download


12/16/2019 – eCopy Program for Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff

This is an updated version of the guidance that was issued on October 10, 2013. It provides clarification to the processing and technical standards for eCopies based on FDA’s experience to date with the program.

The purpose of this guidance is to explain the new electronic copy (eCopy) Program for medical device submissions… The inclusion of an eCopy is expected to improve the efficiency of the review process by allowing for the immediate availability of an electronic version for review rather than relying solely on the paper version.

Link: www.fda.gov/media/83522/download


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