Devices

Patient Preference Info in Product Life Cycle

FDA has published a draft guidance, Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle, with recommendations on how voluntary patient preference information (PPI) may be considered by FDA staff in medical device decision-making. The document’s objectives are to:

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

The guidance also includes hypothetical examples to illustrate how PPI may inform agency decision-making. “The knowledge gleaned from the use of PPI could be used across the total product lifecycle,” FDA says, “including for review in IDE applications, PMAs, HDE applications, de novo classification requests, or 510(k)s.

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