Implementation Guide for FDA Medical Device Reporting

Here we go with the link:

http://www.fda.gov/downloads/ForIndustry/DataStandards/IndividualCaseSafetyReports/UCM161178.pdf

Timeframe for reporting Adverse Events

1. 24 hour notice – When sponsor is told by PI- Death – Regardless of relatedness or expectedness

2.15 day notice- When sponsor is told by PI- Adverse Events that are either unanticipated or serious and  related or possibly related

3.Within 5 days of receipt - PI or Sponsor- Safety Reports (any adverse experience associated with use of the drug that is both serious and unexpected, Any finding from tests in laboratory animals that suggests a
significant risk for human subjects including reports of mutagenicity.

4.Periodic - PI- All other events must be tabulated for submission at the time of continuing review or final report.

COMPANY CORE SAFETY INFORMATION

It is the reference information by which listed and unlisted are deter-mined for the purpose of periodic reporting for marketed products, but not by which expected and unexpected are determined for expedited reporting.All relevant safety information contained in the Company Core Data Sheet prepared by the Marketing Authorisation Holder and which the Marketing Authorisation Holder requires to be listed in all countries where the company markets the product, except when the local regulatory authority specifically requires a modification.

Individual Case Safety Report in Pharmacovigilance

Information to validate an Individual Case Safety Report in Pharmacovigilance when they receive it from a source( Clinical Trial & Spontaneous):

The criteria for a valid case are:

● an identifiable patient;

● a suspect drug;

● a suspect reaction;

● an identifiable HCP reporter.

In the context of expedited reporting, day zero should be considered the day on which the minimum criteria for a reportable adverse reaction report becomes available to the MAH.