In a newly released document from the FDA, it tells us it would like to help manufacturers of Automated External Defibrillators by reclassifying their devices as Class III, the highest risk group. In a lovely use of the English language the agency says that by raising the requirement it will aid manufacturers in their efforts to reduce the significant number of adverse events reported over the past several years. It says many of these are preventable, and that by having to go through the Pre-Market Approval (PMA) process, companies will of necessity have to exert better and tighter controls over their practices and especially their externally supplied parts.
The FDA proposal can be found here.
FDA requires PMA applications to contain clinical data to support a product’s approval, which might not quite hit the spot in terms of addressing the key issues of adverse events with AEDs. Consequently the agency is admitting that if it does get its way with the new proposal, it will focus its review of the pre-market applications on the more problematic aspects of AEDs rather than by implication burying its head in clinical data.
In addition to the clinical safety and effectiveness data, a PMA must also include a review of a manufacturer’s quality systems information and an inspection of its manufacturing facilities. After approval, manufacturers must submit to the FDA any significant manufacturing changes made to the devices as well as annual reports of the device’s performance.
What happens next is that the FDA will take comments on the proposed order for 90 days. If the proposed order is finalized, the FDA intends to exercise enforcement discretion for those manufacturers that notify the FDA of their intent to file a PMA in a timely manner. The FDA intends to exercise enforcement discretion for a year and a half and won’t be pulling anything off the market in the near term.