As technology evolves and medical devices change as a result, creating even more challenges for regulators, clinical trial designs must adapt to the emerging trends.
With the launch of the National Medical Device Postmarket Surveillance System still years away, manufacturers should focus on the quality of their clinical trial data to increase adoption.
A new guidance document, “Patient Preference Information –Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling,” aims to allow patient perspectives to play a greater role in the regulatory process.
The site was a joint effort between the FDA, the National Institutes of Health (NIH) and the National Library of Medicine (NLM).
The 21st Century Cures Act aims to make a number of significant changes to the design and regulation of medical device clinical trials.
Sponsors of extra-U.S. trials need to carefully monitor the FDA’s requirements for the submission of foreign data.
A major health insurers group has penned a letter to a U.S. Senator in criticism of the 510(k) approval pathway.
The agency has identified 34 new areas of interest, showcasing its ambition to become better informed on the device development life cycle.
Participation in transparency efforts can evidence a commitment to patient safety and moving the medical device field forward.
The administration’s most recent release clears up what is necessary for developers to successfully approach specialized medical device advisory committee (MDAC) panels.