Change control plans for AI/ML, remanufacturing of devices and medical device shortages are among the guidances the FDA Center for Devices and Radiological Health (CDRH) is prioritizing in 2024. The agency is seeking stakeholder feedback on the list of guidance documents it intends to publish in the coming year.
The updated guidance document clarifies what constitutes a statement of the basis for the deficiency and includes examples of well-constructed deficiencies and industry responses to facilitate a more efficient review process.
Priorities include unique device identification and next-generation sequencing for in vitro diagnostics.
FDA issues two new draft guidances that explain when device or software changes require a 510(k) submission.
The agency calls out specific devices that should include human factors data in premarket submissions, along with recommendations for combination products.