Devices

Senators Have More Software Pre-Cert Questions

Sens. Elizabeth Warren (D-MA), Patty Murray (D-WA), and Tina Smith (D-MN) are raising additional questions on the CDRH software pre-certification program after receiving the 6/19 response from FDA acting commissioner Ned Sharpless and CDRH director Jeffrey Shuren to the senators’ initial 10/18/18 questions. In a 10/30 letter to Sharpless and Shuren, the senators say they “support the agency's efforts to update its medical device review regime to better accommodate digital health devices.”

But the three also assert that “it is essential that changes to FDA’s regulatory framework are done in compliance with the current statutory framework and do not compromise public safety. Based on the updated materials you have provided us on the Pre-Cert Pilot Program, we continue to have concerns about the program. These concerns primarily relate to (1) the agency's ability to ensure public safety under a ‘precertification’ regime, particularly through its proposed ‘Excellence Appraisals’; (2) the appropriateness of the de novo pathway as a statutory basis for the pilot; and (3) the agency's use of real-world performance data to assess the safety and efficacy of software as a medical device approved through the pilot.”

The remainder of the 10-page letter lists and explains 18 additional questions the senators want to have answered on their three main concerns.

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