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From Health Law Daily, January 29, 2015

FDA to charge up its AED review process

By Lisa A. Weder

The FDA announced in a Final rule issued January 29, 2015, that it is strengthening its review process of automated external defibrillators (AEDs) by requiring AED manufacturers to submit premarket approval applications (PMAs). The new review procedures will allow closer monitoring of these AEDs’ design and manufacture, which will improve the quality and reliability of these devices and their necessary accessories, which includes batteries, pad electrodes, adapters, and hardware keys for pediatric use (Final rule, 80 FR 4783, January 29, 2015).

Background. The Medical Device Amendments of 1976 to the federal Food, Drug, and Cosmetic Act (FDC Act) (P.L. 94–295) established three regulatory classes for medical devices. The three device classes are based on the degree of control necessary to assure that the various types of devices are safe and effective. The three classes are class I (general controls), class II (special controls), and class III (premarket approval). The most regulated devices are in Class III. AEDs fall into the Class III device category, because they support or sustain human life or take part in preventing impairment of human health.

PMAs are essentially a private license granted to applicants for marketing a particular medical device that undergo a more rigorous review process. A Class III device failing to meet PMA requirements is considered to be adulterated and cannot be marketed, regardless of the supplier.

According to the FDA, approximately 72,000 medical device reports associated with the failure of AEDs were filed from January 2005 through September 2014. Since 2005, manufacturers have conducted 111 recalls, affecting more than two million AEDs.

Requirements. All new AED and necessary AED accessories must have an approved PMA in effect before being placed in commercial distribution. The FDA conducts inspections of manufacturers’ facilities prior to approval. After approval, manufacturers are required to submit to the FDA any changes made to the devices that affect safety or effectiveness, as well as annual reports on device performance. The FDA acknowledged that the imposed PMA process may result in increased regulatory costs to AED manufacturers, but that public health trumps these costs.

Effective dates. The PMA requirement for AEDs takes effect July 29, 2016, as long as manufacturers notify the FDA of their intent to file a PMA by April 29, 2015. The FDA will not enforce compliance with the 90-day deadline for PMA submission for currently marketed AEDs and necessary AED accessories until January 29, 2020.

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