Medical device warning letter draft pilot; availability--FDA. Notice

The Food and Drug Administration (FDA) is planning to initiate a pilot program involving the medical device industry that is a continuation of the "medical device industry initiatives." This draft pilot concerns the issuance of warning letters for quality system, premarket notification submission (510(k)), and labeling violations. This draft pilot is intended to optimize resource utilization, enhance communication between industry and FDA, and provide firms with incentives to promptly correct violations or deficiencies. The draft pilot includes eligibility criteria and procedures for the issuance of warning letters and will not be implemented until after the public comment period has expired.