💰FY 2026 Medical Device User Fees
The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2026. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee Amendments of 2022 (MDUFA V), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2026, which apply from October 1, 2025, through September 30, 2026, and provides information on how the fees for FY 2026 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.
Learn More💉FDA Notice on Dermal Fillers
The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee (the Committee). This meeting was announced in the Federal Register of July 3, 2025. The amendment is being made to reflect a change in the ADDRESSES and SUPPLEMENTARY INFORMATION portions of the document. There are no other changes.
Learn More📋FDA Medical Device Reporting Requirements and Compliance Overview
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Learn More📄FDA Information Collection Approvals and Business Implications
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Learn More📋Regulatory Hearing on FDA Correction for 21 CFR Part 16
The Department of Health and Human Services published a rule correcting errors in 21 CFR Part 16. It reinstates specific provisions concerning the regulation of medical devices and tobacco products, detailing statutory provisions related to their approval, modification, and potential administrative actions. These updates are crucial for ensuring accurate regulatory compliance for affected businesses.
Learn More💰Proposed Medicare and Medicaid Payment Policies for CY 2026
This major proposed rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; codification of establishment of new policies for: the Medicare Prescription Drug Inflation Rebate Program under the Inflation Reduction Act of 2022; the Ambulatory Specialty Model; updates to the Medicare Diabetes Prevention Program expanded model; updates to drugs and biological products paid under Part B; Medicare Shared Savings Program requirements; updates to the Quality Payment Program; updates to policies for Rural Health Clinics and Federally Qualified Health Centers update to the Ambulance Fee Schedule regulations; codification of the Inflation Reduction Act and Consolidated Appropriations Act, 2023 provisions; updates to the Medicare Promoting Interoperability Program.
Learn More🍏FDA Approves Gardenia (Genipin) Blue Color Additive for Foods
The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of gardenia (genipin) blue in various foods, at levels consistent with good manufacturing practice (GMP). We are taking this action in response to a color additive petition (CAP) submitted by Exponent, Inc., on behalf of the Gardenia Blue Interest Group (GBIG).
Learn More🏥FDA Notice on Information Collection for Medical Device Programs
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed revision of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection requirements associated with the Q-Submission and Early Payor Feedback Request Programs for medical devices and Qualification of Medical Device Development Tools.
Learn More💉FDA Notice on Dermal Fillers Advisory Committee Meeting
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Learn More📋FDA Notice on Approved Information Collections and Business Impact
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Learn More