FDA Policy/General

Medical Device User Fee Rates Posted

Federal Register Notice: FDA is announcing the fee rates and payment procedures for medical device user fees for fiscal year 2017. The standard fee (adjusted base amount) for a premarket application, including a BLA, and for a premarket report and a BLA efficacy supplement, is $234,495 for FY 2017. For a panel-track supplement, the rate is 75% of the standard fee; for a 180-day supplement —15% of the standard fee; for a real-time supplement — 7% of the standard fee; for a 510(k) premarket notification — 2% of the standard fee; for a 30-day notice — 1.6% of the standard fee; for a 513(g) request for classification information —1.35% of the standard fee; for an annual fee for periodic reporting concerning a Class 3 device — 3.5% of the standard fee. For all submissions other than a 510(k) premarket notification, a 30-day notice, and a 513(g) request for classification information, the small business fee is 25% of the standard (full) fee for the submission. For a 510(k) premarket notification submission, a 30-day notice, and a 513(g) request for classification information, the small business fee is 50% of the standard (full) fee for the submission. The annual fee for establishment registration, after adjustment, is set at $3,382 for FY 2017. To view this 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

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