Latest Federal Register Notices
HIV Tests Down Classified to 510(k)
05/13/2022 Federal Register notice: FDA is issuing a final order to reclassify certain human immunodeficiency virus (HIV) serological diagnostic and supplemental tests and HIV nucleic acid diagnostic and supplemental tests, which are postamendments Class 3 devices with the product code MZF, into Class 2 (special controls), subject to premarket notification. The reclassification will reduce the regulatory burdens associated with these device types, as manufacturers will no longer be required to submit a PMA and instead now can submit a 510(k). To view the notice, click here.
Meeting on User Fee Financial Transparency
05/12/2022 Federal Register notice: FDA is announcing a 6/7 public meeting entitled “Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments.” The meeting will include presentations from FDA on topics related to the financial management of certain user fee programs, including presentations on the agency’s five-year financial plan for the user fee programs. To view the notice, click here.
Gastrointestinal Drugs Committee Renewal
05/11/2022 Federal Register notice: FDA has announced the renewal of its Gastrointestinal Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 3/3/2024. To view the notice, click here.
Glucotrol Not Withdrawn Due to Safety/Efficacy: FDA
05/10/2022 Federal Register notice: FDA has determined that Pfizer’s Glucotrol (glipizide) tablets, 2.5 mg, were not withdrawn from sale due to safety or effectiveness reasons. The determination will allow the agency to approve ANDAs that reference the product if all other legal and regulatory requirements are met. Glucotrol is indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus. To view the notice, click here.
Drug Quality Assessments Guidance
05/10/2022 Federal Register notice: FDA has made available a draft guidance entitled “Benefit-risk Considerations for Product Quality Assessments.” The document discusses how FDA assesses risks, sources of uncertainty, and possible mitigation strategies for a product quality-related issue and how those considerations inform FDA’s understanding of the potential effect on a product. It also discusses how unresolved product quality issues may be addressed in in relation to the agency’s regulatory decision making. To view the notice, click here.
Guide on Device Quality Improvement Program
05/09/2022 Federal Register notice: FDA has made available a draft guidance entitled “Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program.” The document describes the program that uses third-party appraisals to guide device quality improvements. To view the notice, click here.