Recent Department of Health and Human Services regulations affecting small businesses

Centers for Medicare & Medicaid Services seeks public comment on proposed information collection activities under the Paperwork Reduction Act; interested parties may submit feedback on burden estimates and collection methods.

Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests is rechartered with five new members and will hold public meetings July 14-15, 2026 to advise HHS and CMS on diagnostic laboratory test issues.

National Institutes of Health Director's office will hold a public meeting to discuss agency priorities and research funding strategies.

Center for Scientific Review holds closed meetings to review and discuss NIH grant applications and funding decisions affecting small research businesses and academic institutions.

HHS maintains a current list of certified laboratories and testing facilities authorized to conduct urine and oral fluid drug testing for federal workplace drug testing programs under the Mandatory Guidelines.

Medicare announces a public meeting to receive comments on payment amounts for new and revised laboratory test codes under the Clinical Laboratory Fee Schedule for calendar year 2027.

Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests holds public meetings September 15-16, 2026, to review payment rates for diagnostic tests with insufficient data from the May 1–July 31, 2026 reporting period.

Federal agencies seek public comment on proposed information collection requirements affecting small businesses; submit feedback by the deadline specified in the Federal Register notice.

FDA seeks 60-day public comment on proposed exemptions from premarket notification requirements for certain class II clinical toxicology test system devices under 21st Century Cures Act procedures.

FDA classifies phototherapy devices for reducing acute post-surgical incision appearance as Class II medical devices, subject to special controls to ensure safety and effectiveness.

The National Institute of Biomedical Imaging and Bioengineering will hold a public meeting to discuss research funding priorities and grant review procedures for biomedical imaging and bioengineering projects.

FDA requests public input on obesity's effects on drug pharmacokinetics and pharmacodynamics during development to inform safety, effectiveness, and dosing guidance for obese patients.

FDA establishes public docket to collect examples of how patient-focused drug development meetings have influenced drug development efforts, community engagement, research priorities, and advocacy strategies.

FDA classifies the laser-powered inferior vena cava filter retrieval catheter as a Class II medical device, requiring special controls to ensure safety and effectiveness for cardiovascular applications.

The FDA classifies radiation therapy marking devices as class II medical devices, requiring special controls to ensure safety and effectiveness while reducing regulatory burden for manufacturers.