The US Food and Drug Administration's (FDA) has finalized a change in policy that will soon require all Automated External Defibrillators (AEDs) to undergo a more rigorous regulatory review process meant to ensure the devices—which have failed in tens of thousands of reported cases since 2005—function reliably when they are needed most.
The move, which was first announced in 2013, relates to the way in which FDA approves medical devices. Currently, most high-risk medical devices are approved through a rigorous "Premarket Approval" (PMA) process which requires the submission of new clinical data to show that a device is both safe and effective.
However, some manufacturers use a shortcut of sorts to bring their devices to market. Under the 1976 Medical Device Amendments (MDA), device makers can bring a product to market under a "premarket notification" procedure, otherwise known as the 510(k) process. Instead of obtaining new clinical data, device makers can show that their device is "substantially equivalent" to an already-approved predicate device, which indicates that their device would be as safe and effective as the predicate.
A shrinking subset of medical devices can also take advantage of another shortcut to bring their devices to market. Under the Medical Device Amendments, any product already marketed as a medical device was allowed to remain on the market without needing to submit a PMA application to FDA. They were, however, classified as Class III ("high-risk") medical devices as a precautionary measure. FDA has since down-classified many of these devices to lower risk categories.
This series of regulatory pathways has allowed many AEDs to come to market not through FDA's PMA process, but instead through the far less rigorous 510(k) pathway referencing predicate defibrillators approved prior to 1976, FDA noted.
FDA: No More 510(k)—Only PMA
FDA has now finalized a regulation that will require all AEDs—even ones already on the market—to be assessed under the PMA process.
The reason for the change, FDA explained in a press statement, was that regulators have become aware of "approximately 72,000 medical device reports associated with the failure of these devices."
"Since 2005, manufacturers have conducted 111 recalls, affecting more than two million AEDs," FDA noted. "The problems associated with many of these recalls and reports included design and manufacturing issues, such as inadequate control of components purchased from other suppliers.
The numbers supplied by FDA are far higher than estimates supplied by the agency in 2013, which then said it was aware of 88 recalls and approximately 45,000 reports.
FDA said it will not take action against any AED or AED accessory already on the market until 29 January 2020, when it expects all marketed AEDs to be covered by an approved PMA. New devices, however, will be required to be covered under the PMA process much sooner.
A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976.
A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976.
Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed [Product Development Protocol] in effect before being placed in commercial distribution.
However, FDA's enforcement strategy will involve some leeway relative to the regulation, it said.
"Given the importance of these devices in emergency situations, AEDs currently on the market will remain available while manufacturers work to meet the new PMA requirements. The FDA does not intend to enforce the PMA requirement for AEDs until 29 July 2016, as long as manufacturers notify the FDA of their intent to file a PMA by 29 April 2015. The FDA does not intend to enforce the PMA requirement for currently marketed, necessary AED accessories until 29 January 2020."
Effective Date of Requirement for Premarket Approval for Automated External Defibrillator Systems
FDA Press Announcement