🏥Unique Device Identifier Requirements for Combination Products
Unique Device Identifier Requirements for Combination Products; Draft Guidance for Industry and FDA Staff; Availability
Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled "Unique Device Identifier (UDI) Requirements for Combination Products." This draft guidance is intended to assist industry and FDA staff in understanding how FDA's unique device identifier (UDI) requirements apply to combination products with device constituent parts.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The draft guidance outlines UDI requirements for combination products, crucial for compliance in the medical device industry. It significantly impacts design and labeling processes for businesses, requiring adherence to FDA regulations. Compliance implies potential costs associated with labeling, submission, and keeping records, which are vital considerations for business owners.