• Oscar Garcia

Concluding the Quality in 510(k) Review Program Pilot

On April 26, 2021, the FDA announced the decision to conclude the "Quality in 510(k) Review Program Pilot". After May 30, 2021, the FDA will no longer accept them. Companies should consider using the Voluntary "eSTAR Pilot Program".

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Responsibilities Actively execute quality assurance in design development, including but not limited to: Support design control deliverables. Author verification and validation protocols and reports.