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- FDA Issues Temporary Guidance on New CARES Act Provision Requiring Certain Device Notifications to CDRH
FDA Issues Temporary Guidance on New CARES Act Provision Requiring Certain Device Notifications to CDRH
May 14, 2020, Covington Alert
The recently-enacted Coronavirus Aid, Relief, and Economic Security Act (CARES Act) added new section 506J to the Federal Food, Drug, and Cosmetic Act (FDCA). This section requires manufacturers of certain devices to notify FDA of an interruption or permanent discontinuance in manufacturing during, or in advance of, a declared public health emergency. On May 6, FDA’s Center for Devices and Radiological Health (CDRH) issued a direct-to-final guidance document addressing: (1) who must notify CDRH, (2) devices for which CDRH requires notification, (3) when to notify CDRH, (4) what information to include in the notification, and (5) how to notify CDRH. This guidance is intended to remain in effect only for the duration of the COVID-19 public health emergency.
August 25, 2020, Covington Alert
On August 19, the Department of Health and Human Services (HHS) announced a new policy concerning laboratory developed tests (LDTs). Under this policy, HHS has determined that the Food and Drug Administration (FDA) must engage in notice-and-comment rulemaking before requiring premarket review of LDTs. Depending on the next steps from HHS and FDA, this ...
March 29, 2020, Covington Alert
Medical device manufacturers are facing numerous novel legal, regulatory, and commercial issues as a result of the evolving COVID-19 public health emergency. This slide presentation addresses key regulatory considerations for medical device companies seeking to supply products that are in critical need, including the Emergency Use Authorization pathway and other ...
February 24, 2020, Covington Alert
This e-alert reviews trends emerging from warning letters and untitled letters concerning product advertising and promotion issued in 2019 by the Office of Prescription Drug Promotion (OPDP) of the Center for Drug Evaluation and Research (CDER), the Advertising and Promotional Labeling Branch (APLB) in the Office of Compliance and Biologics Quality (OCBQ) of the ...