Devices

FDA Steps to Promote Medical Device Innovation and Access

FDA commissioner Scott Gottlieb says the agency’s Medical Device Innovation Access Plan is intended to enable patients and providers to have efficient access to new and innovative medical products that meet the agency’s standard for safety and effectiveness. His statement says FDA is taking new steps to promote beneficial medical device innovation including:

Completion of the agency’s first qualification of a medical device development tool to provide a more objective platform for developing devices in cardiovascular health. The tool is a 23-item questionnaire that measures health information reported directly by patients with heart failure. Gottlieb says the tool has the potential to help engineers designing heart failure devices to more efficiently and accurately quantify how much their device could actually improve a patient’s quality of life.
Posting a CDRH blog on medical device development tools.
Releasing a draft guidance on the agency’s new Breakthrough Devices Program created under the 21^st Century Cures Act. Gottlieb says the new program is intended to help patients more quickly access certain devices that more effectively diagnose or treat life-threatening or irreversibly debilitating diseases or conditions, such as technologies that have no alternative or that offer a significant advantage over FDA-cleared or approved alternatives.
· Finalizing two guidance to help innovators determine when they need to submit a new 510(k) prior to making a change to a legally-marketed device subject to premarket notification requirements. One guidance discusses when to submit a 510(k) for a change to an existing device, and the other discusses software changes to an existing device. Gottlieb says the guidances do not change the agency review standard, but rather enhance predictability and consistency for innovators deciding when to submit a new 510(k), thus lowering the barriers to innovation and improving patient care by reducing unnecessary submissions to FDA for changes that could not significantly affect device safety or effectiveness.

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