Devices

MDUFA 4 Discussion of 510(k)s, PMAs Delayed

Issues that did not receive full discussion due to time constraints at a 12/15/15 MDUFA $ reauthorization meeting included 510(k) total time to decision reduction, third-party 510(k) review, digital health, leveraging standards, device-specific guidance, PMA process enhancements and total product life cycle, access to review summaries, and deficiencies traced to references. Just-released meeting minutes say FDA staff noted that they had provided some requested data on 513(g) submissions before the meeting and acknowledged that AdvaMed, MDTA, and MITA may present a 513(g) proposal at the 1/20 negotiation meeting.

The two sides discussed establishing working groups to address technical details about personnel recruitment, IT, complex topics for pre-submissions, pre-submissions/SIMS, de novo, CLIA waivers, mechanisms for addressing workload uncertainty, and the PMA proposals. They agreed to develop the working group logistics over the next two weeks with a goal of holding technical working group discussions early in January so that key discussion points may be reported at the 1/20 meeting.

Participants also discussed details of their respective proposal packages. FDA presented in-depth information for several proposals, including review process infrastructure, Q-submissions, de novo, CLIA waivers, patient-centered data, evidence from real world experience, and mechanisms for addressing workload uncertainty. The two sides discussed questions and general observations about remaining proposals, but did not have a detailed discussion due to time constraints. They agreed to form working groups to further address proposals that require focused work by subject matter experts.

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