21 CFR 600.80 - Postmarketing Reporting of Adverse Experiences

What it says

Licensed manufacturers of biological products must develop written procedures for the surveillance, receipt, evaluation and reporting of postmarketing adverse experiences to FDA. They must submit expedited reports for serious and unexpected adverse experiences, periodic reports on the required schedule, and keep records of the information.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• It is the biologics counterpart to 21 CFR 314.80, which applies to drugs.
• Information from any source, including complaints and literature, can start the reporting clock.
• Written procedures should be clear on who receives information and how fast it moves to the safety function.

What FDA inspectors look for

• Whether written procedures for adverse experience handling exist.
• Whether expedited and periodic reports were submitted on time.
• Whether records are complete and retained.

Related regulations