FDA Postpones Enforcement of Combination Product Rules
The FDA issued two guidances on postmarketing safety reporting for combination products, pushing back reporting requirements for certain combination products and clarifying reporting rules for their constituent parts.
In one guidance, titled Compliance Policy for Combination Product Postmarketing Safety Reporting, the agency said it will not immediately enforce certain provisions of the 2016 Postmarketing Safety Reporting rule.
The FDA said it will not enforce recordkeeping requirements for combination product applicants who use the agency’s Electronic Medical Device Reporting System (EMDRS) and the Adverse Event Reporting System (FAERS) before July 31, 2019.
The agency also will not enforce the rules on combination product applicants using the Vaccine Adverse Event Reporting System (VAERS) for individual case safety reports until Jan. 31, 2020.
In a separate draft guidance, titled Postmarketing Safety Reporting for Combination Products Guidance for Industry and FDA Staff, the agency detailed how to comply with the PMSR rule, noting the rule applies to both combination product applicants and constituent part applicants.
Both categories must meet the safety reporting requirements associated with the application type for which the product received the marketing authorization. Only combination product applicants, however, are subject to certain safety reporting requirements associated with the constituent parts of the product, the agency said.