While the degree of risk and a company’s history dictate the level of regulatory scrutiny a device recall audit gets, recall strategies are expected to document supply chain communications down to the patient, FDA and Health Canada officials say.
Both agencies plan to issue guidance soon on what evidence is acceptable to show that a company’s recall has been effective. In the meantime, devicemakers must continue to meet recall coordinators’ individual expectations, the regulators said Sunday.
Ann Ferriter, acting director of risk management operations within CDRH’s Office of Compliance, and Chris Rose, manager of Health Canada’s Medical Device Compliance Unit, spoke at the Regulatory Affairs Professionals Society’s 2012 conference.
Recall files such as call lists and courier receipts of notification are generally considered to be satisfactory proof of contact. But it all “depends” on what individual Health Canada investigators and FDA recall caseworkers say is acceptable, they said, acknowledging the industry’s confusion on the issue.
A recent FDA report found 25 percent of all recalled devices were the result of bad software.
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