Devices

Legislative MDUFA 4 Changes

New funding to be phased in over the course of MDUFA 4 will be used to implement proposed MDUFA 4 enhancements. A summary of draft recommended legislative changes dated 10/25 shows new funding of $47,419,400 in FY 2018, $54,849,400 in FY 2019, $64,339,400 in FY 2020, $76,563,400 in FY 2021, and $77,313,400 in FY 2022. The amounts will be adjusted for inflation each year, the document says.

Proposed statutory changes to implement the agreement include:

increasing the premarket notification submission fee from 2% of the PMA fee to 3.4%;
reducing the fee small businesses pay for a premarket notification submission from 50% of the standard fee to 25%;
establishing a fee to be collected for de novo classification requests equal to 30% of the PMA fee; and
providing that de novo classification requests from small businesses are eligible for a reduced fee of 25% of the standard fee.

The draft also includes wording to implement the agreement provisions negotiated by the parties.

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