The US Food and Drug Administration plans to formalize processes for managing feedback requests received from medical device companies cited for deficiencies following establishment inspections, helping firms to determine adequate responses and corrective actions.
The new draft guidance from the agency would set up a standardized process through which companies that have received FDA Inspectional Observation Form (Form 483) inspectional observations may submit requests for nonbinding feedback, as well as for how the agency reviews and answers these requests.
Manufacturers may receive Form 483 notices following onsite inspections by FDA staff that identify quality system deficiencies or violations of the US Food, Drug and Cosmetics Act. Companies must respond to a Form 483 and describe planned courses of action to address cited observations within timeframes set by FDA. Requests for feedback to FDA from medical device manufacturers must meet eligibility criteria in order to receive responses. FDA will respond to requests for feedback and proposed corrective actions within 45 days.