Devices

CDRH Medical Device Development Tools Help Developers: Shuren

CDRH director Jeffrey Shuren says the FDA Medical Device Development Tools (MDDT) program is a way for the agency to qualify tools that medical device developers can use in the development and evaluation of medical devices. Writing in an online FDA Voices post, Shuren says qualification means the agency has evaluated the tool and concurs with available supporting evidence that the tool produces scientifically-plausible measurements and works as intended within the specified context of use.

“Although the MDDT qualification program is not meant to replace the consensus standard development and recognition process,” Shuren writes, “FDA views the MDDT qualification program as a complementary program for evaluating and recognizing tools that are useful for medical device evaluation and to support regulatory decision-making.”

The article also discusses the Catalog of Regulatory Science Tools that provides a peer-reviewed resource for companies to use where standards and MDDTs do not yet exist. “The tools reduce the need for device developers to design ad hoc test methods and allow them to focus their limited resources on how well their new product works, not how well it may be tested,” Shuren says. “Ad hoc testing can slow the process of bringing innovative devices to market because the developer must develop and validate a testing methodology in addition to developing a new product. As a result, FDA must then assess both the testing methodology on a case-by-case basis to ensure that tests are fit for purpose, as well as the new product. It is therefore of great benefit to both innovators and regulators to use a common set of methodologies whenever possible, and over time we would expect the most useful regulatory science tools to progress through the qualification process to become full-fledged MDDTs.”

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