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Latest Posts › Medical Devices

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FDA releases draft guidance on expansion of abbreviated 510(k) Program

On April 12, the FDA released draft guidance discussing an expansion of its Abbreviated 510(k) program for medical devices. This new guidance would allow a submitter to establish substantial equivalence by demonstrating that...more

5/1/2018 / 510(k) RTA , Draft Guidance , Food and Drug Administration (FDA) , Medical Devices , Pharmaceutical Industry

Proposed Legislation to Relax Rules on Medical Device Reporting Passes U.S. House

On July 13, 2017, the U.S. House of Representatives passed a bill that would triple the amount of time in which medical device manufacturers are required to report certain malfunctions of some products to the Food and Drug...more

7/17/2017 / Food and Drug Administration (FDA) , Manufacturing Defects , Medical Devices , Proposed Legislation , Reporting Requirements

New FDA Draft Guidance on Benefit-Risk Factors Affecting Medical Device Compliance and Enforcement

In June, the U.S. Food and Drug Administration released draft guidance to clarify the benefit and risk factors it may consider in compliance and enforcement actions involving medical devices. Medical device manufacturers...more

8/11/2016 / Draft Guidance , Food and Drug Administration (FDA) , Manufacturers , Medical Benefits , Medical Devices , Public Comment , Risk Assessment

FDA Issues Final Ruling Allowing Medical Device Manufacturers to Use Stand-Alone Symbols on Labels

This week, on June 14, 2016, the FDA issued a final ruling revising its medical device and certain biological product labeling regulations to allow, for the first time, manufacturers to use graphical representations of...more

6/20/2016 / Biologics , Federal Food Drug and Cosmetic Act (FFDCA) , Final Rules , Food and Drug Administration (FDA) , International Harmonization , Manufacturers , Medical Devices , Product Labels

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