FDA to Soon Require Medical Device Companies to Submit Adverse Event Data Electronically

Posted 19 June 2015 | By Alexander Gaffney, RAC 

FDA to Soon Require Medical Device Companies to Submit Adverse Event Data Electronically

The US Food and Drug Administration (FDA) is reminding manufacturers and importers of medical devices about an upcoming requirement to submit all adverse event reports electronically.


The shift was made final in February 2014 under a final rule, Medical Device Reporting: Electronic Submission Requirements.

While medical device manufacturers have long been required under 21 CFR 803 to report known or suspected adverse events to FDA, the regulator has traditionally accepted reports in paper form (Form 3500A).

But as with many forms submitted to FDA, the agency is moving toward an electronic submission standard, arguing that digital submission is faster, cheaper, more accurate and allows for better analysis and reporting.

Under the rule, manufacturers and importers of medical devices will have just two electronic options to report MDRs to FDA: One for single reports using the eSubmitter tool, and the other for batch reports using the Health Level 7 Individual Case Safety Reporting (ICSR) tool.

Use of FDA's paper-based form, 3500A, will be limited to user facilities, including hospitals.

Upcoming Compliance Date

One notable aspect of FDA's February 2014 rule was the amount of time the agency said it would give medical device companies to become compliant with the rule: about 18 months.

The rule is set to come into effect on 14 August 2014, at which time all MDR submissions will need to be made electronically.

While the date of implementation might have fallen off the radar of some companies, FDA is now out with a new package of technical documents intended to help companies implement the changes and comply with the upcoming requirements.

"Manufacturers should consider registering for an Electronic Submission Gateway (ESG) account and submit a test submission as soon as possible to ensure that they are electronic submission compliant by 14 August 2015, regardless of which transmission method they choose," FDA explained. "Manufacturers may begin testing their submissions as early as 29 June 2015."

FDA has also released a guidance, issued in February 2014, to help companies comply with the new requirements.



Technical Documents

Categories: Regulatory News

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