US FDA Issues Notice on Pre-Amendment Class III Medical Devices

Authored by: John Lockwood

On April 9 of 2009, the FDA announced in the Federal Register requiring the manufacturers of twenty-five (25) Class III preamendment devices to submit a summary of safety or efficacy information, including information which had not been submitted under section 519 of the Food, Drug, and Cosmetic Act. The twenty-five (25) devices identified are those Class III preamendment devices for which a final regulation requiring the submission of a PMA has yet to be issued. These devices were marketed in the U.S. prior to the Medical Device Amendments to the Food, Drug, and Cosmetic Act of 1976 which authorized the FDA to review new medical devices. This announcement is the first step towards completing the review of Class III device types predating the 1976 law, as was recommended by the U.S. Government Accounting Office (“GAO”).

On January 15, 2009, the GAO issued a long-awaited report evaluating the use of the 510(k) process by the Food and Drug Administration (“FDA”).  As part of the FDA Amendments Act of 2007 (“FDAAA”), Congress required GAO to conduct a study to assess the use of the 510(k) premarket notification process for review of certain class III devices and to investigate devices cleared through the 510(k) process, to determine whether the process is being utilized appropriately. The report criticized the timeliness of FDA’s classification efforts in regard to certain devices that were legally marketed prior to the Medical Device Amendments of 1976, so-called “preamendment devices.”   Noting that three decades have passed since the Medical Device Amendments of 1976, GAO urged FDA to take immediate steps to address the remaining class III devices that continue to be eligible for 510(k) review.

The FDA classifies medical devices into three (3) categories according to their level of risk to patients. Class III devices represent the highest level of risk and generally require a showing of safety and effectiveness before they may be marketed. Although these high-risk medical devices are subject to a premarket approval (“PMA”) process, preamendment class III devices were cleared through the 510(k) pathway until FDA issues regulations requiring a PMA.  Under the law, these devices were not immediately required to undergo the premarket approval process. The law required the FDA to issue a rule subjecting the devices to that requirement.

Manufacturers of the 25 remaining device types must submit the requested information within 120 days. The FDA will review the submitted data and, based on the risk level, issue regulations for each device type that either will require manufacturers to submit premarket approval applications or will re-classify the devices into Class I or Class II.