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The US Food and Drug Administration (FDA) on Friday outlined a set of proposed reforms to advance modern manufacturing methods and increase supply chain visibility. In a proposed rule, the agency said it will enable distributed manufacturers to register as a single entity under a “hub-and-spoke” model and clarified when foreign establishments must register as a manufacturer.

The US Food and Drug Administration (FDA) recently issued two warning letters to companies for marketing medical devices without authorization, including devices for eyelid cleaning and an infection control system. Additionally, the agency sent an untitled letter to a company regarding misleading promotional communications for a prescription migraine drug.

Researchers at the US Food and Drug Administration (FDA) recently conducted a study in response to a 2024 study that raised safety concerns about metal toxicity from tampons; however, the study found that the potential leaching of metals from tampon usage in even the most conservative conditions was negligible.

The Trump administration has released its latest unified agenda, laying out the proposed and final rules its agencies plan to issue in 2026, including 22 final and 43 proposed rules by the US Food and Drug Administration (FDA).

The US Food and Drug Administration (FDA) and the medtech industry have agreed to commitment letter language for the Medical Device User Fee Amendments (MDUFA VI) program for the next five fiscal years.

The US Food and Drug Administration (FDA) revised its compliance program guide (CPG) for preapproval inspections (PAIs) for new drugs. This update emphasizes a risk-based approach to making decisions about the necessity of inspections and clarifies the agency’s use of alternative methods instead of relying solely on onsite inspections.

Industry groups are asking the US Food and Drug Administration (FDA) for greater transparency into its Commissioner's National Priority Voucher (CNPV) pilot, including how the agency intends to transition the pilot into a full-fledged program.

The US Food and Drug Administration (FDA) recently warned a distributor and medical device maker for marketing continuous positive airway pressure (CPAP) machines and related software for treating sleep apnea without securing proper marketing authorization and for inadequate complaint handling. The agency also warned a device maker for misclassifying its products as premarket notification exempt pharmacy compounding kits.

Industry and academic stakeholders have asked the US Food and Drug Administration (FDA) to clarify its objectives and plans for a proposed pilot program to evaluate how artificial intelligence (AI) technologies can help improve early-phase clinical trials. They also said the agency should develop a governance structure with specific metrics and goals and consider aligning its thinking with other regulators.

The European Commission has published two delegated acts that expand the list of well-established technologies (WET) under the Medical Devices Regulation (MDR) that are exempt from conducting clinical investigations and technical assessments. The first regulation applies to implantable devices and Class III devices, while the second regulation focuses on Class IIb implantable devices.