We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
Home » FDA Tips From Unreleased Guidance Help Dx Company Get 510(k)
FDA Tips From Unreleased Guidance Help Dx Company Get 510(k)
June 3, 2011
As the FDA faces continuing criticism about unpredictable 510(k) review standards, one devicemaker says the agency helped it win clearance by giving it a heads up on a pending guidance.