FDA is issuing a final guidance document to revise its compliance policy regarding the deadline for filing premarket approval (PMA) applications for previously cleared accessories necessary to the operation of automated external defibrillator (AED)1 systems. This policy is based, in part, in consideration of the burden on healthcare facilities as they transition to FDA-approved AEDs and on the manufacturers as they prepare to implement the PMA requirements while addressing the challenges related to Coronavirus Disease 2019 (COVID-19).
This guidance is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the FD&C Act and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices.
The initial compliance date for regulatory filings for AED accessories was Feb. 3, 2020, a date that slid back to Feb. 3, 2021, after the agency heard from stakeholders about the need to update the filings and the replacement accessories, reports Bioworld. The new compliance date is Feb. 3, 2022.
Download the final guidance document at FDA.
Reference
1 On February 3, 2015, FDA published a final rule calling for the submission of premarket approval applications for AEDs and their necessary accessories (80 FR 5674). AEDs that were cleared prior to the implementation of this regulatory requirement are sometimes referred to as “legacy” AEDs.
