Devices

Patient Access to At-Home Technologies

CDRH is soliciting public comment on increasing patient access to at-home use medical technologies. The request for comment says access to medical devices outside a clinical care setting “may help bridge the gap by bringing healthcare directly to patients wherever they are….” The Center says it particularly wants public comment on these questions:

ways FDA can support the development of medical technologies, including digital health technologies and diagnostics, for use in non-clinical care settings, such as at home;
factors that should be considered to effectively institute patient care that includes home-based care;
ways that digital health technologies can foster the conduct of clinical trials remotely and support local or home-based healthcare models;
ways FDA can facilitate individuals accessing medical technologies in remote locations when they are unable or unwilling to access care in clinical settings;
the processes and medical procedures, including diagnostics, that would be ideal for transitioning from a hospital and/or healthcare setting to non-clinical care settings;
design attributes and user needs that would facilitate using medical technologies, including diagnostic and therapeutic devices, for use in a non-clinical setting;
digital health technology design attributes that could better facilitate their use by diverse patient populations outside of clinical settings; and
potential methods and strategies for evidence generation and data analysis that could facilitate the regulatory review of medical technologies intended for use in non-clinical settings.

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