FDA Upgrades External Defibrillators to Class III, Cites Demonstrated Risk
The FDA has announced plans to require PMAs for all automated external defibrillators (AEDs).
The move — which reclassifies AEDs as Class III devices — is motivated by reports of 45,000 adverse events and 88 recalls between 2005 and 2012, said CDRH Deputy Director William Maisel. Many of the recalls were related to preventable manufacturing, design or component flaws.
“AEDs are critically important, with proven clinical utility,” Maisel said. “But we believe they can be more reliable. Tens of thousands of adverse events and 88 recalls are too many.”
A proposed reclassification rule is slated for publication in the March 25 Federal Register. Once finalized, manufacturers will have 90 days to notify the FDA of plans to file a PMA and an additional 15 months to submit it.
The agency expects each manufacturer cleared to distribute AEDs in the U.S. will need to file only separate PMAs for AEDs intended for public use and AEDs with more advanced functionality designed for use by medical workers. AEDs that are currently cleared for marketing in the U.S. will remain on the market during the approval process.
Most, if not all, manufacturers have the clinical data needed for a PMA on hand and won’t need to conduct new clinical trials, Maisel said. He also anticipates that bench testing will suffice for future modifications to approved AEDs, speeding enhanced models to patients and lessening the regulatory burden on companies.
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