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Medical Device Reporting; FDA eSubmission Mandate

Posted on August 31, 2015 · Posted in FDA Regulatory Updates

The Medical Device Reporting (MDR) regulation explains mandates for manufacturers, importers, and device user facilities to report device-related adverse events and product problems to the FDA.  Details regarding reporting requirements can be found here: (21 CFR 803).
As of August 14, 2015 all manufacturers and importers of medical devices are required to submit Medical Device Reports (MDRs) to the FDA in an electronic format.  Written reports will no longer be accepted

There are 2 options for reporting:
1. The eSubmitter:
The eSubmitter application, developed by the FDA, can be downloaded and used to send one electronic medical device report at a time (for low volume reporting).

2. The HL7 ICSR (Health Level 7 Individual Case Safety Reports):
A Medical Device company can use the HL7 ICSR standard to develop its own, custom application (for high volume and batch reporting).

A regulatory review: Complaint handling and MDR time requirements

Keep in mind, complaint files are connected to MDR event files because a complaint must be evaluated to determine if it is a reportable adverse event.

FDA definition of a complaint:
“ any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.

Manufacturers and importers are required to maintain complaint files and establish and maintain procedures for receiving, reviewing, and evaluating complaints. Complaint files that are found to be reportable MDR events should be maintained in a separate portion of the complaint file or otherwise clearly identified.”

Summary of Mandatory Reporting Requirements for Manufacturers and Importers

REPORTER WHAT TO REPORT TO WHOM WHEN
Manufacturers 30 day reports of deaths, serious injuries and malfunctions FDA Within 30 calendar days of becoming aware of an event
5-day reports for an event designated by FDA or an event that requires remedial action to prevent an unreasonable risk of substantial harm to the public health FDA Within 5 work days of becoming aware of an event
Importers Reports of deaths and serious injuries FDA and the manufacturer Within 30 calendar days of becoming aware of an event
Reports of malfunctions Manufacturer Within 30 calendar days of becoming aware of an event

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