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Device Companies Dodge Controversial Changes at FDA

Medical-device makers led by Medtronic Inc. won’t face drastic changes to U.S. regulatory reviews as they had feared, at least not initially.

The Food and Drug Administration announced today 25 steps it intends to take in 2011 to ensure the safety of medical devices approved under the agency’s 510(k) program and to make the process more predictable for companies and investors. The list omits the most controversial of 55 proposals made in August by an internal agency task force, according to the FDA.