Experts Disagree Over Whether FDA Has Authority For Pre-Cert

Device industry experts disagree over whether a suite of new documents related to FDA’s nascent medical software precertification program answers a key question posed by stakeholders: Does the agency have statutory authority to implement pre-cert? Aaron Josephson, a senior director at ML Strategies and former senior policy advisor at FDA’s device center, said the agency does provide a satisfying answer to the question by rooting its authority for pre-cert in its de novo device review process. However, Brad Thompson, a...