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Guidance Document updates on the FDA website

All divisions

  • Certificates of Confidentiality (distributed for comment purposes only) – This draft guidance describes FDA implementation of the revised provisions applicable to the request for, and issuance of, a Certificate of Confidentiality (CoC). The 21st Century Cures Act (Cures Act) (Public Law 114-255) amended the Public Health Service Act (PHS Act), section 301(d) (42 U.S.C. 241(d)) relating to the issuance of CoCs. A CoC is intended to help protect the privacy of human subject research participants from whom identifiable, sensitive information is being collected or used in furtherance of the research.
  • Bridging for Drug-Device and Biologic-Device Combination Products – 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 copackaged combination products.
  • Requesting FDA Feedback on Combination Products – The purpose of this guidance is to discuss ways in which combination product sponsors can obtain feedback from FDA on scientific and regulatory questions and to describe best practices for FDA and sponsors when interacting on these topics.

CDER

CDER & CBER

CDRH

  • Magnetic Resonance (MR) Coil – Performance Criteria for Safety and Performance Based Pathway – This draft guidance provides performance criteria for magnetic resonance (MR) coils in support of the Safety and Performance Based Pathway. Under this framework, submitters planning to submit a 510(k) using the Safety and Performance Based Pathway for MR coils will have the option to use the performance criteria proposed in this draft guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.

CDRH & CBER

CBER

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