EPA has published its May 2026 TSCA Section 5 statements of findings for certain new-chemical and significant-new-use submissions determined not likely to present an unreasonable risk under the reviewed conditions of use. The notice is not a new medical-device restriction, but it can be useful upstream intelligence when suppliers introduce new polymers, additives, coatings, or other chemical inputs.
FDA has formally published Recognition List 066 in the Federal Register, covering additions, replacements, and revisions to recognized consensus standards used in medical-device premarket submissions. Manufacturers should review not only the new standard editions but also FDA recognition numbers, complete versus partial recognition, and transition deadlines for declarations of conformity.
Eight selected FDA Class II recall events for 16–22 August 2026 highlight neonatal breathing-circuit failures, erroneous diagnostic results, software-driven measurement and analyzer risks, an implant machining defect, endotoxin-related surgical-kit actions, a CT bolus-tracking issue, and high-volume urostomy pouch leakage. The issue emphasizes clinical follow-up, inventory control, result review, software correction, and component-level quality management.
FDA has classified the recall of certain Medline convenience kits containing B. Braun bupivacaine hydrochloride components as Class I. Medline Industries, LP is correcting affected kits because they include Huons Bupivacaine Hydrochloride in Dextrose Injection, USP that was recalled for quality issues.
FDA’s general draft guidance on Predetermined Change Control Plans remains in draft status, but section 515C of the FD&C Act is already in effect and manufacturers may submit PCCPs today. The draft explains what planned device modifications may be appropriate for a PCCP and the information FDA expects manufacturers to provide.
FDA has issued a discussion paper seeking feedback on how generative AI-enabled medical devices should be assessed across risk classification, premarket evaluation, and postmarket monitoring. The paper outlines possible approaches including a two-axis risk framework and competency-based premarket assessment, but it does not establish new regulatory requirements.
FDA has classified the recall of specified BD Intraosseous Vascular Access System Needle Set lots as Class I after out-of-tolerance dimensions were linked to difficulty removing the obturator and potential delays in therapy; the FDA recall database lists Bard Access Systems, Inc. as the recalling firm.
Eight selected FDA Class II recall events for 9–15 August 2026 highlight diagnostic false negatives, interventional imaging software failures, a potential sterilization underdose, endotoxin-related kit actions, reagent rework, cryosurgical pressure risk, and an incorrect guidewire. The issue centers on clinically meaningful failures plus substantial inventory, notification, correction, and replacement work.