Devices

FDA Harmonizing MDR Adverse Event Coding with Other Regulators

FDA says it is no longer adding new adverse event codes for Medical Device Reporting (MDR) in response to device manufacturer requests. As part of an adverse event harmonization effort with the International Medical Device Regulators Forum (IMDRF), FDA expects to transition to the new coding as new annexes from the group are published. Manufacturers and other stakeholders who would like to request that a new adverse event code be added should follow the IMDRF code request process.

The IMDRF Adverse Event Reporting terminologies working group is iteratively producing new code sets, which are posted to the IMDRF documents repository as new annexes on a singular guideline document. “As each new annex is published, FDA intends to update the corresponding FDA code set to harmonize with the new IMDRF code set; as a result, each IMDRF code will map to a single, distinct FDA code,” an FDA notice says. “At this time, the FDA’s eMDR system is not configured to accept the IMDRF codes, however, once the IMDRF working group has published the initial version of all IMDRF code sets, the FDA plans to update eMDR to accept IMDRF codes, in addition to the FDA codes and NCIt [NCI Thesaurus] codes that are currently accepted. This will be possible because all three (FDA, NCIt, and IMDRF) coding systems will be harmonized with a one-to-one mapping for each code across all three systems.”

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