Recent Department of Health and Human Services regulations affecting small businesses

FDA classifies manual surgical instruments for orthopedic implant patient selection as Class II medical devices, requiring special controls to ensure safety and effectiveness while reducing regulatory burden on manufacturers.

FDA classifies transcutaneous electrical nerve stimulators for congestion relief as class II devices subject to special controls to ensure safety and effectiveness while reducing regulatory burden.

FDA's Pharmacy Compounding Advisory Committee will hold a public meeting to advise on bulk drug substances for inclusion in the Section 503A list, with a public docket open for comments.

FDA reclassifies non-invasive bone growth stimulators (product codes LOF and LPQ) from class III to class II devices, requiring premarket notification and establishing special controls for safety and effectiveness.

SAMHSA proposes new information collection requirements for substance abuse and mental health services programs; public comment period details available in Federal Register notice.

FDA amends animal drug regulations to reflect application actions for new animal drugs during October through December 2025 and improve regulatory accuracy and readability.

HRSA solicits public comment on a proposed Information Collection Request for performance measures related to the Transforming Pediatrics for Early Childhood Program under the Paperwork Reduction Act of 1995.

FDA draft guidance recommends next-generation sequencing methods for nonclinical safety assessment of investigational human genome editing products in gene therapy.

HHS Administration for Children and Families will hold a Tribal Consultation meeting with tribal Head Start and Early Head Start program leaders to discuss funding allocations and service delivery improvements for American Indian and Alaska Native c…

Center for Scientific Review will hold closed meetings to review and discuss grant applications and related matters; specific meeting dates and locations available upon request to the agency.

FDA holds public meeting on expanding nonprescription drug access and requests stakeholder comments; no specific deadline or financial impact stated for small businesses.

Center for Scientific Review holds closed meetings to review and evaluate grant applications and research proposals across multiple federal funding agencies.

HHS Office of Minority Health is accepting nominations for Tribal Advisory Committee delegates to advise on indigenous health innovation priorities and tribal consultation activities.

The Advisory Council on Alzheimer's Research, Care, and Services convenes for its second 2026 meeting to discuss federal agency updates, long-term care advancements, and faith-based partnership models for dementia support services.

FDA seeks public comments on financial transparency and efficiency of prescription drug, biosimilar, and generic drug user fee programs at a public meeting.