Carolyne Hathaway

Latham & Watkins LLP

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Latest Posts › Medical Devices

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FDA Announces Planned Changes to the 510(k) Premarket Notification Program

Agency signals forthcoming changes that could impact manufacturers’ ability to commercialize new medical devices. Background - On November 26, 2018, officials from the Food and Drug Administration (FDA or the Agency)...more

12/3/2018 / 510(k) RTA , FDA De Novo Clearance , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Medical Devices , Pharmaceutical Industry , Regulatory Agenda

FDA to Strengthen Oversight of Certain In Vitro Diagnostic Devices

In the wake of a new Medicare reimbursement framework, FDA plans stricter regulation of some in vitro diagnostic devices. On July 31, 2014, the U.S. Food and Drug Administration (FDA; Agency) announced its intent to...more

8/21/2014 / Centers for Medicare & Medicaid Services (CMS) , CLIA , Clinical Laboratories , Food and Drug Administration (FDA) , Healthcare , Medical Devices , Medicare , Reimbursements

Preparing for a "New Era of Medical Product Development"

FDA report demonstrates support for personalized medicine and more efficient regulatory pathways. In a new report issued by the Food and Drug Administration (FDA) on October 28, 2013, Commissioner of Food and Drugs...more

11/8/2013 / Food and Drug Administration (FDA) , Medical Devices , Personalized Medicine

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