FDA Policy/General

Latest Federal Register Notices

Guide on Device Software Policy Changes
Federal Register notice: FDA makes available a final guidance on “Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act.” 09/27/2019

Guide on Type A Medicated Articles
Federal Register notice: FDA makes available a draft guide on demonstrating bioequivalence for soluble powder oral dosage form products and Type A medicated articles made from soluble APIs. 09/27/2019

Clinical Decision Support Software Guide
Federal Register notice: FDA makes available a draft guidance entitled “Clinical Decision Support Software.” 09/27/2019

Draft Guide on Device e-Submissions
Federal Register notice: FDA makes available a draft guidance on medical device regulatory electronic submissions. 09/26/2019

Atropine Sulfate Not Withdraw Over Safety/Efficacy
Federal Register notice: FDA determines that Hospira’s atropine sulfate ansyr plastic syringe was not withdrawn due to safety or effectiveness reasons. 09/25/2019

Regulatory Review Period for Med–El EAS Hearing Device
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Med-El Electromedizinische Gerate’s medical device Med–El EAS, intended to provide electrical stimulation for patients with low-frequency hearing sensitivity. 09/25/2019

Info Collection Extension on Transplant Tissues
Federal Register notice: FDA seeks comments on an information collection extension for “Human Tissue Intended for Transplantation — 21 CFR Part 1270.” 09/25/2019

Draft Guide on Patient Input on Device Trials
Federal Register notice: FDA makes available a draft guidance entitled “Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations.” 09/24/2019

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

Read more

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