FDA Policy/General

Latest Federal Register Notices

Peripheral Vascular Atherectomy Devices
5/21/2021 Federal Register notice: FDA has made available a final guidance entitled Peripheral Vascular Atherectomy Devices — Premarket Notification Submissions. The document provides updated recommendations for premarket submissions for a new or modified peripheral vascular atherectomy device. To view the notice, click here.

More ANDA-specific Bioequivalence Guidances
5/21/2021 Federal Register notice: FDA has made available additional draft and revised draft product-specific guidances (XXX DELETE XXX)on, among other things, the design of bioequivalence studies to support ANDAs. To view the notice, click here.

Guide on Device MRI Testing and Labeling
5/21/2021 Federal Register notice: FDA has made available a final guidance on Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment. It provides recommendations on the testing needed for assessing the safety and compatibility of medical devices in the magnetic resonance environment and the recommended format for such information in medical device labeling. To view the notice, click here.

Guide on ANDAs for Synthetic Peptide Products
5/20/2021 Federal Register notice: FDA has made available a final guidance entitled ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin. The document is intended to help potential applicants in determining when an application for a synthetic peptide drug product that refers to a previously approved peptide drug product of recombinant deoxyribonucleic acid origin should be submitted as an ANDA rather than an NDA. To view the notice, click here.

Feasibility Study Guide on Diabetes Control Devices
5/20/2021 Federal Register notice: FDA has made available a draft guidance entitled Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus. The document provides recommendations for feasibility and early feasibility clinical studies for certain medical devices intended to therapeutically improve glycemic control in patients with Type 2 diabetes mellitus. To view the notice, click here.

Implanted Brain-Computer Interface Device Guide
5/19/2021 Federal Register notice: FDA has made available a final guidance entitled Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation — Non-Clinical Testing and Clinical Considerations. The agency defines implanted brain-computer interface devices as neuroprostheses that interface with the central or peripheral nervous system to restore lost motor and/or sensory capabilities in patients with paralysis or amputation. To view the notice, click here.

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