ARTICLE SUMMARY:
Balancing the need for clinical vs non-clinical data to meet EU clinical evaluation requirements for moderate-risk devices; DOJ's Data Security Program mandates tighter control over data going to entities in China and other countries of concern; Little clarity on the number of laid-off vs. reinstated staffers; UK's MHRA proposes indefinite recognition of CE-marked devices, streamlines review of other countries' products; FDA's user fees on the rise; Recent FDA digital device authorizations
