Zdrowie i gospodarka · 29/03/2019
FDA Publishes Draft Guidance for Device Establishment Inspection Processes and Standards
The Food and Drug Administration (FDA) has released a draft guidance document outlining the agency's plan to review and update its inspection processes and standards for medical device establishments, in compliance with the FDA Reauthorization Act of 2017, which requires regular reviews and updates to ensure consistency and continuity of inspections.