FDA Policy/General

FDA Streamlined Compliance Policy for Certain Respirators

FDA has issued a draft guidance outlining a proposed compliance policy that could ease certain premarket requirements for respirators already approved by National Institute for Occupational Safety and Health, signaling a shift toward reduced regulatory burden for widely used protective devices.

The draft document covers a range of air-purifying respirators — including surgical N95s, non-surgical filtering facepiece respirators (FFRs), powered air-purifying respirators (PAPRs), and reusable elastomeric respirators—when used for medical purposes such as protecting healthcare workers from airborne pathogens.

FDA says the proposed policy is based in part on NIOSH’s existing regulatory framework, which evaluates respirator performance under federal standards. The agency also cited postmarket data supporting the safety and effectiveness of these devices.

If finalized, the policy would allow FDA to rely more heavily on NIOSH approvals for certain respirators, aligning with the agency’s “least burdensome” approach to device regulation and potentially reducing the need for additional premarket submissions in some cases.

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