Devices

Certificate for Devices Not Exported from U.S.

FDA is implementing a certification program for medical devices not exported from the U.S., which is mandated under the Coronavirus Aid, Relief, and Economic Security Act. If certain requirements are met, a Certificate for Device Not Exported from the U.S. (CDNE) may be issued upon request, an agency notice says. In addition, FDA has revised its Web-based application system, CDRH Export Certification Application and Tracking System (CECATS), which can be used for submitting requests for a CDNE. The system offers a reduction in processing time, real-time validation of firm-specific data, and status updates on requests

FDA says that a CDNE may be issued for medical devices manufactured outside of the U.S. that are cleared, approved, granted a De Novo authorization or that are subjects of an approved humanitarian device exemption, on the market prior to 5/28/1976 or exempt from Section 510(k), but are not exported from the U.S. and are identical to the FDA authorized device with no modifications to the technology, intended use, indications for use or labeling. “Establishments that wish to request a CDNE must have been inspected by the FDA within three years of the date of the request, or audited pursuant to an FDA-recognized program or a program in which the FDA participates and the findings of such audit have been provided to the FDA within three years from the date of the request,” the agency says.

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