FDA Policy/General

Latest Federal Register Notices

Guide on Bench Testing Data in Device Submissions
Federal Register notice: FDA makes available a final guidance entitled “Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions.” 04/26/2019

Guide on Polyethylene Used in Devices
Federal Register notice: FDA makes available a final guidance entitled “Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices.” 04/26/2019

Info Collection Extension on Device Small Biz Fee
Federal Register notice: FDA submits to OMB an information collection extension entitled “Medical Device User Fee Small Business Qualification and Certification.” 04/26/2019

Info Collection Extension on Device Sterilization Agreements
Federal Register notice: FDA seeks comments on an information collection extension for its “Agreement for Shipment of Devices for Sterilization — 21 CFR 801.150.” 04/26/2019

Final Guide on UDI Convenience Kit Labeling
Federal Register notice: FDA makes available a final guidance on “Unique Device Identification: Convenience Kits.” 04/26/2019

Covariates in Randomized Clinical Trials Guide
Federal Register notice: FDA makes available a draft guidance entitled “Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics with Continuous Outcomes.” 04/25/2019

Draft Guide on Initiating Voluntary Recalls
Federal Register notice: FDA makes available a draft guidance entitled “Initiation of Voluntary Recalls Under 21 CFR part 7, subpart C.” 04/24/2019

Panel to Discuss Surgical Staplers & Hemostatic Agents
Federal Register notice: FDA announces a 5/30-31 Advisory Committee meeting to discuss reclassification proposals for surgical stapler devices and certain absorbable hemostatic agents. 04/24/2019

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome