AAMI Cautions FDA About “Unintended Consequences” of Regulating Medical Device Repair
Asserting its role as “a neutral organization that highly values its…’honest broker reputation,’ ” AAMI has submitted comments to the FDA concerning medical device repair and refurbishment in advance of the agency’s June 3 deadline. The 18-page letter, followed by nearly 40 more pages of attachments, notes the dangers of silo-based thinking and advocates for consensus-based standards over regulation.
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