AdvaMed Questions FDA Classification Proposal

The Association for the Advancement of Medical Instrumentation (AAMI) is reporting that the Advanced Medical Technology Association (AdvaMed) has asked the Food and Drug Administration (FDA) to revisit its proposed amendments to regulations governing the classification and reclassification of medical devices.

“We are gravely concerned regarding the wide-ranging impact of these proposed revised regulations governing the classification and reclassification of medical devices,” the trade group said in its comments on the proposed rule.

The agency issued its proposal in March, saying it would amend its regulations to be in line with provisions in the FDA Safety and Innovation Act (FDASIA) governing the classification and reclassification of medical devices. In addition, it proposed changes unrelated to the FDASIA requirements.

Medical devices are classified either Class I, II, or III based on risk, with Class III considered higher risk and subject to premarket review. Members of industry can petition to have devices reclassified to reflect lower or higher risk.

During a call explaining the proposal, agency officials emphasized that it would clarify the threshold criteria for Class III, or high-risk, devices—specifically, when it may find that general and special controls that apply to Class I or II devices are insufficient.

In its comments, AdvaMed said the proposed rule went far beyond clarifying these criteria and would “substantially” rewrite the definition of Class III.

“This proposed rule is not simply an update or implementation of FDASIA provisions—it implements new processes inconsistent with FDASIA for reclassification,” the trade group added.

The association also questioned the agency’s estimates on the time and cost burdens the proposed rule would impose. The FDA estimated it receives six petitions for reclassification per year, with the average time to prepare the petition being 497 hours. But AdvaMed said this estimate misses the mark, particularly if a device is moving from Class II to III.

“Based on prior Class III product submissions to [the] FDA, the average time required to prepare and submit a PMA application, including time needed to assemble supporting data, is approximately 4,380 hours per response,” according to AdvaMed.

“The burden of complying with the proposed rule must be considered and substantially revised to assure an accurate estimate of the burned of proposed collection of information and overall utility of the information,” the group concluded.

The FDA initially requested that comments be submitted by June 23, but extended the comment period through Sept. 22.

Source: AAMI

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