FDA Clarifies 510(k) Review Clock Policy In MDUFMA Guidance
FDA will allow extensions of up to 90 days for firms to respond to additional information (AI) requests, the agency explains in a guidance document on 510(k) user fee performance goals
FDA will allow extensions of up to 90 days for firms to respond to additional information (AI) requests, the agency explains in a guidance document on 510(k) user fee performance goals