![FDA Guidance on Laboratory Developed Tests: Scope](https://www.regdesk.co/wp-content/uploads/2024/07/FDA-compliance-guide-on-IVDs-scope.jpg)
FDA Guidance on Laboratory Developed Tests: Scope
The new article describes in detail the applicability scope of the new regulatory policy for laboratory-developed tests.
The new article describes in detail the applicability scope of the new regulatory policy for laboratory-developed tests.
The new article highlights certain specific aspects pertaining to the regulatory framework, emphasizing the key points to be taken into consideration.
The US Food and Drug Administration (FDA), the authority responsible for medical device regulation, issued guidance intended to assist the manufacturers of In Vitro Diagnostic Devices (IVD) in filing applications for the CLIA Waiver. CLIA Waiver: The Scope of...
The difference between CLIA and FDA standards