FDA Guidance – updates

Please find below the recently published Guidance and draft guidance documents:

Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act | FDA

Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers | FDA

Global Unique Device Identification Database (GUDID) | FDA

Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions | FDA

Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices | FDA

510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review | FDA

Draft

Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations | FDA

Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies | FDA

Study of Sex Differences in the Clinical Evaluation of Medical Products | FDA

Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency | FDA

Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices | FDA