The possibility of a recall pilot program and expedited enforcement initiatives top the list of regulatory concerns devicemakers have with the FDA, according to a panel at the annual Medical Device Regulatory, Reimbursement and Compliance Congress last week. Allegations have increased that the FDA is ordering the recall of older products when newer versions are approved under a “corrective fix” pilot program, the panelists said. Other concerns include inconsistencies in the agency’s review of 510(k)s, device registries and postapproval requirements.
Devices & Diagnostics Letter