FDA’s Breakthrough Devices Program provides expedited interaction and prioritized review for eligible medical devices intended to treat or diagnose life-threatening or irreversibly debilitating diseases or conditions.

FDA has published a discussion paper seeking stakeholder feedback on regulatory considerations for generative AI-enabled medical devices, including risk assessment, premarket evaluation, benchmarking, clinical confirmation, postmarket monitoring and foundation models.

FDA has issued draft guidance on potency assessment of active immunotherapy products, covering potency assays, critical quality attributes, bioassays, physicochemical assays and product-specific considerations.

FDA has issued updated guidance on 510(k) submissions for hemodialysis blood tubing sets, covering device description, performance testing, biocompatibility, sterility, shelf life, packaging and labeling.

FDA has issued guidance on applying human factors and usability engineering to medical devices, focusing on user interface design, use-related risk management, critical tasks and human factors validation testing.

FDA opens the FY2027 MDUFA Small Business Request window on August 1, 2026. Learn eligibility rules, user fee discounts, and submission steps.

FDA updates its list of authorized companion diagnostic devices to 226 entries, covering NGS assays, liquid biopsies, group labeling, and key biomarkers.

The MDSAP Regulatory Authority Council releases the 2026 Forum Outcome Statement, detailing 2025 performance, MDO pilot results, and EU MDR alignment.

FDA has issued draft guidance on biocompatibility testing of medical devices under the ASCA Program, covering recognized standards, laboratory accreditation, test methods and premarket submission content.

FDA CBER has updated SOPP 8704 on MDUFA user fee payments and billing activities, including electronic payments, payment verification, user fee holds, refunds and establishment registration fees.

FDA has updated its technical specifications guidance on submitting next-generation sequencing protocols, data and analyses to the Division of Antivirals.

The FDA has announced upcoming eMDR system enhancements, including AEMS consolidation, country code requirements and IMDRF adverse event code updates.

FDA classifies the Endoscopic Traction Device as a Class II medical device with Special Controls, setting performance, safety, and labeling requirements applicable to medical device and IVD manufacturers.

The FDA has classified the ingestible gastrointestinal blood detection capsule as a Class II medical device, establishing special controls to support the safety and effectiveness of this innovative diagnostic technology.

The FDA has classified radiological machine learning-based quantitative imaging software with predetermined change control plans as Class II medical devices, establishing special controls to support the safe development and regulatory oversight of AI-enabled imaging software.

FDA has published draft guidance on Forms FDA 3542a and FDA 3542, clarifying requirements for Orange Book patent listings, electronic patent submissions, and the management of patent information throughout the medicinal product lifecycle.

FDA has published draft guidance on Essential Drug Delivery Outputs (EDDOs) for drug delivery devices and combination products. Learn how the recommendations may impact design controls, verification, validation, and change management activities.

The FDA has updated its draft guidance on medical device manufacturer communications with payors, health economic information, and investigational products.

The FDA has released eSTAR Version 7.0, integrating new Human Factors content and expanding PreSTAR capabilities. Learn how these changes may affect medical device manufacturers preparing FDA submissions.

FDA has established a new Class II classification with special controls for transcutaneous electrical nerve stimulators (TENS) intended to treat fibromyalgia symptoms, creating a new regulatory pathway for manufacturers.