FDA MANDATORY RECALL DECISION SHOULD BE MADE WITHIN 10 DAYS

FDA MANDATORY RECALL DECISION SHOULD BE MADE WITHIN 10 DAYS after the agency issues a cease distribution and notification order, the Health Industry Manufacturers Association says in Sept. 9 comments on FDA's proposed rule on medical device recall authority. HIMA expresses concern that in the proposal "no deadline is established for FDA to issue its decision" on whether or not to require a device recall.

Noting the lack of a deadline, HIMA says it "is troubled at the possibility that a cease distribution and notification order could be in operation indefinitely." As an alternative to a 10-day deadline, HIMA suggests that cease distribution orders could automatically expire if FDA fails to issue a decision within "a fixed number of days."

The mandatory recall provisions of the Safe Medical Devices Act of 1990 call for FDA to order manufacturers to halt distribution and notify device users if "there is a reasonable probability that a device...would cause serious, adverse health consequences or death." FDA would then hold a hearing to determine actions necessary under the order and to decide whether to require a mandatory recall of the device. FDA published a proposed rule on the provisions in the June 14 Federal Register; the comment period ended Sept. 12 ("The Gray Sheet" June 20, p. 9).

HIMA also says that the agency should establish a fixed time period for its review of a manufacturer's strategy for notification and recall. In the proposed rule, manufacturers are required to initiate their strategy as soon as it is submitted to FDA, which "can cause much wasted effort in the likely event that a comprehensive, expensive strategy is undertaken by a company only to be changed at a later date once FDA has had an opportunity" to review it, HIMA says. "A more streamlined, productive, and cost-effective procedure" would include an FDA deadline within "a reasonably short time period" so the recall could "proceed rapidly."

Another time issue involves FDA's proposed three-calendar-day timeframe for manufacturers to request a regulatory heating on the cease distribution and notification order. In its letter, HIMA called that deadline "unacceptably short" because an intervening weekend could reduce the response time to just one work day. As a remedy, HIMA suggested that FDA "change the computation of time method to working days and retain the three-day period, or change the period to five days and retain the computation of time as calendar days."

In general comments on the proposed rule, HIMA asks FDA to publish "more specific standards and factors to be met for a mandatory recall to occur." Such guidelines would "help to assure consistency among recall decisions" and "greatly assist the industry and the agency," HIMA said.

The association also suggests that the agency should pursue informal communication with manufacturers in order to resolve safety and efficacy issues before issuing a cease distribution order. "The proposed rule should be modified to acknowledge explicitly the opportunity and preference for open, informal communication between the agency, manufacturers and distributors, and expert consultants prior to or in lieu of a cease distribution order," HIMA says.