FDA Delays Post-market Safety Reporting Requirements for Combination Products

EMERGO SUMMARY OF KEY POINTS:

• Postponed FDA enforcement of post-market safety reporting rules (PMSR) for combination products
• Delay allows combination product applicants more time to implement appropriate reporting and recordkeeping systems and procedures

The US Food and Drug Administration have pushed back enforcement of post-market safety reporting (PMSR) requirements for combination product manufacturers to give affected registrants more time to ensure compliance.

According to new FDA guidance, the delay affects portions of PMSR rules finalized in late 2016 in order to allow combination product applicants more time to implement appropriate reporting, recordkeeping and related technologies and systems.

New PMSR compliance deadlines

FDA has set two new PMSR enforcement dates tied to which system combination product applicants use to submit individual case safety reports, or ICSRs:

• July 31, 2019 for combination product applicants reporting ICSRs through the FDA Adverse Event Reporting System (FAERS) and the Electronic Medical Device Reporting System (eMDR)
• January 31, 2020 for combination product applicants using the Vaccine Adverse Event Reporting System (VAERS) for ICSR submissions

Ahead of the new enforcement deadlines, FDA has issued additional draft guidance to more fully explain PMSR compliance requirements.

Related FDA medical device and combination product regulatory information:

• US FDA regulatory consulting for medical device and IVD manufacturers
• FDA eMDR adverse event reporting support for medical device companies
• Whitepaper: Implementing a post-market surveillance program