In December 2016, the FDA published a final rule for post-market safety reporting (PMSR) for combination products. This applies to combination products that are subject to premarket review by the FDA.
The following rules must be complied with by all combination product applicants:
- application type-based PMSR requirements
- constituent part-based PMSR requirements
- associated submission process and record-keeping requirements
• July 31, 2019, for Combination Product Applicants using the FDA Adverse Event Reporting System (FAERS) and Electronic Medical Device Reporting System (eMDR) to report ICSRs.
• January 31, 2020, for Combination Product Applicants using the Vaccine Adverse Event Reporting System (VAERS) to report ICSRs.
The FDA set the above dates of compliance, but it will be delayed because the FDA wants all combination product applicants to have enough time to update and edit reporting and record-keeping systems, including completing all the procedures to comply with all the requirements.
The FDA will help all the applicants to comply with the requirements, offering education to the applicants about the procedures that they are less familiar with and providing guidance, recommendations and technical specifications to comply with these provisions.
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