Devices

Insights from Q&A on FDA Breakthrough Designation Webinar

Breakthrough device designation requests are confidential and will not be maintained in an FDA database. That’s one of the insights gained by attorney Rachel Hunt (Hyman, Phelps & McNamara) from the question and answer period following an FDA Webinar on the program.

Writing in her firm’s FDA Law Blog, Hunt says that FDA’s response to a question was that a sponsor may wish to publicize that it has received a breakthrough designation, but the agency will not maintain a public database of that information. Other information gleaned from the sessions was:

FDA said it has no formal plan to publish program metrics;
FDA did not preclude the possibility that a medical device with a preventive indication could qualify for breakthrough status, but said the determination may require careful wording of the indications and discussions with program staff;
a breakthrough designation may include a statement of the planned marketing application and FDA will ensure the product is, in fact, subject to premarket review, but will not comment on whether the sponsor has chosen the appropriate pathway;
the breakthrough process is not a substitute for a 513(g);
while there is no expected level of product development prior to seeking breakthrough designation, FDA is looking for evidence on technical success and clinical impact; and
the breakthrough designation program is not intended for devices with a broad indication in which a subset of the indication could qualify as a breakthrough.

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