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On September 20, 2019, FDA issued four separate draft guidance documents for industry and FDA administration staff that provide extensive objective performance criteria (OPC) for five...more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
Would Not Require Collaboration by the Drug Sponsor; FDA Requests Comments on Potential Approach -
The Food and Drug Administration (FDA) requests comment on a potential approval pathway for “ devices referencing drugs”...more
Following its recent announcement that it would not finalize its 2014 draft guidance on laboratory developed tests (“LDTs”), the U.S. Food and Drug Administration (“FDA”) issued a Discussion Paper on Laboratory Developed...more