Devices

FDA Publishes 3 X-Ray Guidances

FDA has published three guidances relating to x-ray systems. The first, Performance Standards for Diagnostic X-Ray Systems and Their Major Components; Small Entity Compliance Guide, is intended to assist small entities to comply with a 2005 final rule amending the performance standard for diagnostic x-ray systems and their major components. The document also reflects a 1/20 amendment to the radiological health regulation removing certain reporting requirements for diagnostic x-ray systems and their major components.

The second guidance, Assembler’s Guide to Diagnostic X-Ray Equipment, addresses requirements that apply to diagnostic x-ray equipment under the Electronic Product Radiation Control provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA). The document does not address requirements that apply to such equipment under the medical device provisions of the act.

Medical X-Ray Imaging Devices Conformance with IEC Standards describes the agency’s policy on the regulation of medical x-ray imaging equipment that is subject to the FFDCA and agency regulations that apply to medical devices and electronic products. FDA says it is using the document to harmonize performance standards in the FFDCA with International Electrotechnical Commission standards, where appropriate, to help ensure more efficient and consistent regulatory review of submissions for the products. It also provides recommendations to industry on how to comply with the applicable requirements.

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