Elaine Tseng

King & Spalding

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Latest Posts › 510(k) RTA

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FDA Issues Proposed Rule Classifying Certain Wound Dressings and Liquid Wound Washes For the First Time

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

1/11/2024 / 510(k) RTA , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Medical Devices , Premarket Approval Applications , Proposed Rules , World Health Organization

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Implications for 510(k) Submissions - On September 20, 2019, FDA issued four separate draft guidance documents for industry and FDA administration staff that provide extensive objective performance criteria (OPC) for five...more

9/27/2019 / 510(k) RTA , Draft Guidance , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Pharmaceutical Industry , Premarket Approval Applications , Safety and Performance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

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