FDA Update For In Vitro Diagnostic Test Developers: Updates to the FDA’s Clinical Laboratory Improvement Amendments (CLIA) Web Pages Make Processes Clearer, Easier to Understand The Clinical Laboratory Improvement Amendments (CLIA) and the associated regulations provide the authority for oversight of clinical laboratories and laboratory testing. While the Centers for Medicare and Medicaid Services (CMS)
FDA Update mdi likes to get important information out to the public. New Available Material Makes for a More Informed Patient As… FDA Provides Information on Surgical Mesh Used for Hernia Repair The U.S. Food and Drug Administration (FDA) is providing information for consumers on surgical mesh used for hernia repair. This information includes: Types
FDA Update Assuring the Quality of Medicines is Not So Plain and Simple Report on the State of Pharmaceutical Quality The mission of the Office of Pharmaceutical Quality is to assure that quality medicines are available to the American public. This mission is not easy, but it is critically important. As our new Fiscal Year
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FDA Update Warning: Certain Tattoo Inks Can Cause Serious Illnesses… FDA Issues Draft Guidance on Tattoo Inks The U.S. Food and Drug Administration recently issued draft guidance on tattoo ink to manufacturers and distributors to help recognize situations in which a tattoo ink may become contaminated with microorganisms, and thus, be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
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