On May 29, 2025, the U.S. Food and Drug Administration (FDA) issued a final version of its guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program,” ...
The US Food and Drug Administration (FDA) has announced new steps it is taking to modernize the 510(k) program, which include updates on its Safety and Performance Based Pathway, electronic Submission ...
On October 1, 2024, the Food and Drug Administration (FDA) marked a major milestone in medical device cybersecurity enforcement. This marks one year since the retracted Refuse to Accept (RTA) policy ...
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