Devices

CDRH, Industry Mull Improvements to Pre-Submission Process

CDRH and the medical device industry are exploring the addition of more resources and performance goals under the next Medical Device User Fee Program to improve the Center’s Pre-Submission (Pre-Sub) process. In just-released user fee negotiation meeting minutes, FDA explained that the Pre-Sub consultation process is currently implemented as resources permit, without any specific user fee performance goals attached to the process. As negotiations continue to finalize the next user fee program, FDA and industry continue to work on identifying a mix of resources and performance commitments that will “achieve meaningful and feasible improvements to the process.”

An industry counter proposal on enhancing the user fee program included resources for establishing a Quality Management system at a funding level that FDA estimated was needed,” according to the minutes. “Industry’s counter proposal regarding establishing a more integrated review process for ODE [Office of Device Evaluation] was below the level of resources that FDA estimated would be needed to make the transition. Industry’s counter proposal for the De Novo process also fell short of the resources FDA had estimated are needed to achieve the goals proposed. Likewise, the level of resources industry proposed for improving the CLIA waiver review process was below the amount FDA had estimated is necessary to achieve the performance goals that industry proposed. Additionally, FDA noted that the CLIA waiver program proposals will need a legal review before moving forward. Industry’s counter proposal also included another independent assessment similar to the one conducted during MDUFA III.”

Meeting minutes from a 5/15 negotiation noted that FDA’s latest user fee funding proposal included a base of $680 million plus inflation to maintain the performance goals that will be in place in the final year of MDUFA III. FDA proposed two options with different levels of performance targets and associated resource needs. “The low option included an additional $291 million spread out over five years to support an additional 186 FTEs by the end of MDUFA IV,” the agency said. “The high option included an additional $321.7million spread out over five years to support an additional 215 FTEs by the end of MDUFA IV.” FDA noted that the components of the two options could be reorganized into a hybrid counterproposal, and that all proposed performance goals assume agreement on a fee setting algorithm with inflation and volume adjusters.

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