After enactment of the Medical Device Amendments of 1976, which established three regulatory classes for medical devices, the Food and Drug Administration (FDA) has been required to classify all medical devices into Class I,...more
Implications for 510(k) Submissions -
On September 20, 2019, FDA issued four separate draft guidance documents for industry and FDA administration staff that provide extensive objective performance criteria (OPC) for five...more
FDA Announces Intent to Modernize the Medical Device Review Process that Would Discourage Reliance on Older Devices as Predicates for the 510(k) Process -
Last week FDA released two statements announcing plans and...more