Paul Kim

Foley Hoag LLP

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Latest Posts › Medical Devices

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FDA Issues Emergency Use Authorizations for Additional Medical Devices in Response to COVID-19

On Friday, April 10, 2020, the Food and Drug Administration (FDA) announced that it has issued two additional Emergency Use Authorizations (EUA) in response to the coronavirus pandemic: one for a device that is used to...more

4/15/2020 / Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Medical Devices , Medical Supplies , Personal Protective Equipment

Modernization of the 510(k) Pathway to Market Medical Devices

Introduction - Congress enacted the Medical Device Amendments in 1976 establishing the regulatory framework for evaluating safety and effectiveness of medical devices. The U.S. Food and Drug Administration (“FDA” or...more

11/30/2018 / 510(k) RTA , Food and Drug Administration (FDA) , Medical Devices

FDA Issues Draft Guidance on Medical Device Accessories

On January 16, 2015, the Food and Drug Administration (FDA) issued a draft guidance document titled “Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types.” The draft guidance...more

1/23/2015 / Draft Guidance , Food and Drug Administration (FDA) , Medical Devices

FDA Unveils Anticipated Draft Guidance for the Regulation of Laboratory-Developed Tests

On July 31, 2014, the Food and Drug Administration (FDA) provided Congress notice of its intent to issue draft guidance providing a risk-based framework for the regulation of laboratory developed tests (LDTs) under the...more

8/6/2014 / Clinical Laboratories , Draft Guidance , Enforcement Guidance , Food and Drug Administration (FDA) , Medical Devices , Risk Assessment

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