On 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 by all combination product applicants:
- application type-based PMSR requirements
- constituent part-based PMSR requirements
- associated submission process and recordkeeping 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 above dates of compliances, but it will be delayed because the FDA wants all combination products applicants have enough time to update and edit reporting and recordkeeping systems, including complete 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, providing guidance, recommendations and technical specifications to comply with these provisions.
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