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- CAP Responds to FDA Draft Guidance on Validation of IVDs
The CAP expressed support for draft guidance by the Food and Drug Administration (FDA) on validating in vitro diagnostics (IVDs) for emerging pathogens during emergencies.
The CAP said the proposal would provide necessary guidance for the development of IVDs during a health emergency declared by the Department of Health and Human Services secretary. The CAP letter of support emphasized the vital role pathologists play in test development and validation and further recommended adding a provision to the guidance that encourages test developers to involve practicing pathologists.
The CAP letter also recommended revisions to provide greater flexibility for tests developed within a laboratory setting.