Devices

FDA Electronic Product Certification Program Explained

A new CDRH Learn module tells new manufacturers and importers about the FDA requirements for radiation-emitting products. In the Web video presentation, CDRH electrical engineer Lowell Howard reviews agency regulations and describes its role in regulating radiation-emitting electrical products.

He says that manufacturers of radiation-emitting electrical products have several steps to follow before their products may enter the U.S. market: complying with applicable standards, establishing a quality testing program based on good manufacturing practices, certifying and reporting the product to FDA, and permanently affixing certification and identification labels to their products. Howard also explains that placing defective or non-compliant products into U.S. commerce can have consequences that can include implementing corrective action at no cost to the purchaser.

In the program, Howard provides background on the FDA electronic product radiation control program, explains what electronic product certification represents, defines a manufacturer’s certification requirements, defines a quality testing program, and identifies the consequences of a poor testing program.

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