Devices

FDA Annual Report on CDRH International Harmonization

As part of its MDUFA 5 commitment to promote international harmonization and provide additional CDRH resources for that work, the Center conducts annual assessments of its international activities. The 2025 report lists the five strategies envisioned in the CDRH strategic plan on international harmonization:

increase engagements in international harmonization, convergence, and reliance efforts;
create a mechanism for CDRH to share best practices with trusted partners;
assess the extent of CDRH implementation of IMDRF (International Medical Device Regulators Forum) technical documents;
support creation of a forum to engage with stakeholders to identify opportunities for regulators to leverage one another’s approach to decision-making; and
participate in outreach activities to encourage harmonization, convergence, and reliance.

The report discusses accomplishments for each of the five strategies and pledges to continue the effort as MDUFA 5 enters its remaining years and FDA looks ahead to MDUFA 6.

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