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The FDA posted an update on its Accreditation Scheme for Conformity Assessment (ASCA) pilot, which aims to streamline conformity assessments for medical device submissions that meet yet-to-be-announced standards. Read More
The FDA said it will allow device manufacturers of Class I and unclassified devices another two years to comply with its unique device identification system requirements, which are being phased in over seven years. Read More
The company said that in certain lots of the pacing leads, the connector cap housing may shift and expose the internal wire, risking loss of connectivity or breakage. Read More