Devices

FDA Issues Patient Preference Info Guidance

FDA has published a guidance, Patient Preference Information — Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling, explaining the principal concepts for sponsors and other stakeholders to consider when choosing to collect patient preference information (PPI), which may inform FDA’s benefit/risk determinations in the premarket review of PMAs, HDE applications, and de novo requests. The document is applicable to both diagnostic and therapeutic devices that are subject to the review processes.

“FDA values the experience and perspective of patients,” the guidance says. “The agency understands that patients and care-partners who live with a disease or condition on a daily basis and utilize devices in their care may have developed their own insights into and perspectives on the benefits and risks of devices reviewed under the premarket approval, humanitarian device exemption, or de novo classification pathway. FDA believes that patients can and should bring their own experiences to bear in helping the agency evaluate the benefit-risk profile of certain devices.”

The guidance’s objectives are to:

encourage submission of PPI, if available, by sponsors or other stakeholders to FDA and to aid in FDA decision making;
outline recommended qualities of patient preference studies, which may result in valid scientific evidence;
provide recommendations for collecting and submitting PPI to FDA; and
discuss FDA’s inclusion of PPI in its decision summaries and provide recommendations for including such information in device labeling.

The policy in the guidance, FDA says, is consistent with an earlier benefit-risk guidance.

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