FDA Moves Ahead With Third-Party 510(k) Review
A new guidance document from the US FDA discusses how the agency will accredit and oversee third-party reviewers, as well as how it will determine which 510(k) devices are eligible for outside review.
A new guidance document from the US FDA discusses how the agency will accredit and oversee third-party reviewers, as well as how it will determine which 510(k) devices are eligible for outside review.