US FDA: guidance for abbreviated 510(k) programs finalized, updates Refuse to Accept policy
The US FDA’s Center for Devices and Radiological Health (CDRH) has issued final guidance for its Abbreviated 510(k) premarket notification pathways following proposals in 2018 to expand access to these programs, as well as its Refuse to Accept policy for inadequate or incomplete 510(k) submissions. Abbreviated 510(k) program for faster FDA clearance FDA and CDRH […]
US FDA proposes more transparent process for managing requests for feedback on Form 483 observations
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 The new draft guidance from the agency would set up a standardized process through which companies that have received FDA Inspectional Observation Form […]
US FDA finalizes Safety and Performance 510(k) registration route
FDA’s final guidance on what the agency calls its Safety and Performance Pathway is based on the Abbreviated 510(k) Program; FDA first announced plans to expand the Abbreviated 510(k) Program and published draft guidance in early 2018. Through this market authorization pathway, qualifying device manufacturers would be able to utilize performance criteria identified and approved by FDA to demonstrate […]
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