FDA Update FDA Issues Final Guidance on Content of Premarket Submissions for Device Software Functions The U.S. Food and Drug Administration (FDA) issued the final guidance: Content of Premarket Submissions for Device Software Functions. The final guidance provides information regarding the recommended documentation sponsors should include in premarket submissions for the FDA’s evaluation of the
FDA Update Warning: Certain Tattoo Inks Can Cause Serious Illnesses… FDA Issues Draft Guidance on Tattoo Inks The U.S. Food and Drug Administration recently issued draft guidance on tattoo ink to manufacturers and distributors to help recognize situations in which a tattoo ink may become contaminated with microorganisms, and thus, be potentially injurious to health. This
FDA Update The FDA is Seeking Public Comments CDRH Seeks Public Comment: Increasing Patient Access to At-Home Use Medical Technologies The U.S. Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) seeks input from the public, particularly patients, patient advocacy organizations, health care providers, consumers, the medical device industry, clinical researchers, and
FDA Update Prevention for Drug Shortages Being Addressed Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act” Guidance for Industry The U.S. Food and Drug Administration announced the availability of a draft guidance to help prevent and mitigate drug shortages, titled:
FDA Update Final Guidance: General Considerations for Animal Studies Intended to Evaluate Medical Devices The U.S. Food and Drug Administration (FDA) is issuing this final guidance: General Considerations for Animal Studies Intended to Evaluate Medical Devices. The FDA developed this guidance document to assist medical device sponsors, testing facilities, and others involved in designing, conducting,
FDA Update Standards Change as COVID Pandemic Ends FDA Explains What Will Happen to CDER Guidances and Emergency Use Authorizations as the Public Health Emergency Ends The U.S. Food and Drug Administration published a Federal Register notice explaining the status of guidance documents addressing the COVID-19 public health emergency (PHE), which the Secretary of Health
FDA Update It took awhile but we saw this coming – the EUAs will be ending. Further Guidance Clarification Post COVID Just Announced by FDA Enforcement Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators Today, the U.S. Food and Drug Administration (FDA) divided into two the guidance, Enforcement Policy for
FDA Update Baby Formula Recall Debacle Causes Shakeup at FDA FDA Food Safety Chief Resigns after Formula Recall Due to controversy regarding the massive recall and shortage of baby formula, Frank Yiannas, deputy commissioner of the FDA’s Office of Food Policy and Response will step down from his position as of February 24th. Mr. Yiannas,
FDA Update Spotlight on Children as FDA Announces Funding Opportunity to Support Pediatric Medical Device Development The U.S. Food and Drug Administration (FDA) announced a funding opportunity through the Pediatric Device Consortia (PDC) grants program open through Wednesday, March 29, 2023, 11:59 p.m. (ET). The FDA funds this program to advance the development of medical
A new report on the FDA’s food safety program just came out. One of the recommendations is to break up the Agency into 2: one for food and another for medicine. – READ ON Protecting the nation’s food supply is one of FDA’s primary charges. While affirming that Americans generally have access to safe and
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