Devices

Guide on Covid Effects on Device User Fee Activities

FDA has issued a guidance on “Effects of the Covid-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices — Questions and Answers.” The document says that CDRH is leveraging technology to host teleconferences and video conferences rather than in-person meetings with industry during the Covid-19 public health emergency. Until further notice, all requests for in-person meetings will be handled as requests for teleconferences, and all CDRH meetings previously scheduled as in-person meetings have been converted to teleconferences to be held at the same date and time. CDRH says it remains committed to the Medical Device User Fee Amendments (MDUFA) performance goals, but the Center is experiencing ”considerable increases in Covid-19 activities related to pre-emergency use authorizations (pre-EUAs), EUAs, and the development of policies, requiring shifting of staff resources to focus on these critical activities... Should an original premarket approval application (PMA), panel track PMA supplement, premarket notification 510(k) submission, or de novo request miss its MDUFA performance goal, FDA will follow the missed MDUFA decision procedures outlined in the guidance documents FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals, FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals, and FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals.”

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