Quynh Hoang

King & Spalding

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Latest Posts › Food and Drug Administration (FDA)

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FDA Issued Draft Objective Performance Criteria For Five Device Types

Implications for 510(k) Submissions - On September 20, 2019, FDA issued four separate draft guidance documents for industry and FDA administration staff that provide extensive objective performance criteria (OPC) for five...more

9/27/2019 / 510(k) RTA , Draft Guidance , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Pharmaceutical Industry , Premarket Approval Applications , Safety and Performance Pathway

FDA Announces “Modernization” Reforms to Medical Device Review Process

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

12/4/2018 / 510(k) RTA , Food and Drug Administration (FDA) , Medical Devices , National Evaluation System for Health Technology (NEST)

FDA Considers Approval Pathway for Medical Devices to Unilaterally Cross-Reference Marketed Drug Products

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

12/19/2017 / Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Medical Devices , Pharmaceutical Industry

FDA Issues Discussion Paper on LDTs

Following its recent announcement that it would not finalize its 2014 draft guidance on laboratory developed tests (“LDTs”), the U.S. Food and Drug Administration (“FDA”) issued a Discussion Paper on Laboratory Developed...more

1/21/2017 / Centers for Medicare & Medicaid Services (CMS) , CLIA , Draft Guidance , Food and Drug Administration (FDA) , Laboratory Developed Tests

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