www.fdanews.com/articles/122343-recalls-enforcement-timelines-big-concerns-for-devicemakers
Recalls, Enforcement Timelines Big Concerns for Devicemakers
November 19, 2009
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
Devices & Diagnostics Letter