28 Jul 2025
📋Regulatory Hearing on FDA Correction for 21 CFR Part 16
Regulatory Hearing Before the Food and Drug Administration
Summary
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.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The regulatory document outlines compliance and regulatory requirements related to the food and drug industries, particularly concerning devices and tobacco products. These regulations will impact businesses directly by dictating their operational standards and approval processes for products.