Medical Device Regulation
The Food and Drug Administration today proposed reclassifying surgical staplers for internal use as moderate-risk rather than low-risk medical devices.
The Centers for Medicare & Medicaid Services last week announced planned changes to the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Competitive Bidding Program for 2021.
The Food and Drug Administration intends to finalize guidance early next year on a new approach to its 510(k) program for pre-market review of medical devices.
The AHA opposes tariffs that have been imposed on medical equipment and medical products imported from China that are used in hospitals, as well as potential tariffs under consideration that would impact the health care field.
The Food and Drug Administration today issued draft guidance that provides recommendations to the medical device industry on cybersecurity considerations for device design, labeling and documentation that the FDA recommends be included in premarket submissions for medical devices with cybersecurity…