These are the updates published since 07/01/2025 (when we last put updates on regulatory newsletter) up to and Including 29/05/2025.
- Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program | FDA
- Evaluation of Sex-Specific Data in Medical Device Clinical Studies – Guidance for Industry and Food and Drug Administration Staff | FDA
- Data Standards Catalog | FDA
- Institutional Review Boards Frequently Asked Questions | FDA
- Institutional Review Board (IRB) Written Procedures | FDA
- Evaluation of Sex Differences in Clinical Investigations | FDA
- Premarket Approval Application and Humanitarian Device Exemption Modular Review | FDA
- Electronic Submission Template for Medical Device Q-Submissions | FDA
