FDA’s New eMDR Requirements

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Manufacturers and importers must report adverse events associated with a risk to health or death. Until now, the reports were submitted in hardcopy using MedWatch form 3500A. Managing the volume adverse event reports for industry and the FDA became increasingly difficult over time. The FDA announced its development of an electronic format for submitting Medical Devices Reports. The final rule for requiring the submission of electronic MDRs was announced on February 13, 2014. That regulation goes into effect on August 14, 2015. At that time, all MDRs submitted by manufacturers and importers must be accomplished through the FDA’s Electronic Submissions Gateway (ESG). Hardcopy reports from manufacturers and importers will not be accepted. The information requirements of an adverse event for MDR purposes remain the same. The reporting deadlines of 5, 10 or 30 days technically remain the same, although in practice the deadlines are shorter. The eMDR program is intended to provide greater efficiency, accuracy and utility to the FDA and to the industry.

The FDA’s eMDR requirement for submitting adverse event reports becomes effective August 14, 2015. That deadline is almost here. If you have not prepared for this requirement, you are running out of time. The information requirements that manufacturers and importers must collect concerning an event remain the same. How the information gets to the FDA is not the same. Firms must use an Electronic Submissions Gateway (ESG) to submit MDRs, now known as eMDR. Firms must establishment an account with the FDA to use the ESG for the eMDR program.

With the changes in operational parameters for MDRs, firms need to adjust their reporting program to ensure they provide adequate time to make corrections to their coding errors. eMDRs with errors will be rejected and, therefore, deemed “not filed.” This means firms should exam their MDR program to adapt to the strict eMDR requirements. Unless the FDA issues an acknowledgement of receipt for your eMDR, it is not considered filed. The date you submit the eMDR is not relevant. This creates secondary demands on a firm’s MDR program, CAPA program and its Q.A. functions. Firms need to integrate the new procedural requirements for eMDR. When the FDA will start enforcing the new eMDR requirements is not clear. Typically, the FDA will give the industry enough time to make mistakes or reach a point of unquestionable failure. The industry’s problems are predictable. Likewise, the content of eMDR Warning Letters is predictable. Given the number of years firms have had to implement eMDR, excuses will not be persuasive.

Firms need to reassess their MDR procedures for information accuracy and coding. Efficiency is equally important. MDR requires the prompt management of “risk to health” information. Such information is critical to the medical device postmarket program and equally loaded as an enforcement issue for failures to meet eMDR requirements. Firms no longer have the option of being on a learning curve. Firms need to be sure that their related postmarket programs are well coordinated with eMDR requirements. Otherwise, they will be facing a tough Q.A. problem.

Areas to be Covered:

MDRs reporting elements for
User facilities
New eMDR program requirements
eSubmitter program
HL7 electronic submissions
Electronic Submissions Gateway (ESG) account
Operational deadlines
eMDR rejections
Revisions to related postmarket programs
Quality Assurance coverage
Corrective and Preventive Actions

Who will Benefit:

Device manufacturers
Device importers
User facilities
FDA consultants
Domestic and international regulatory affairs managers
Q.A. managers / training
Complaint and MDR managers
Data processing managers
3rd party complaint managers

Casper E. Uldriks

Casper (Cap) Uldriks brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, served as a senior manager in the Office of Compliance and as an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He understands how FDA thinks, operates and where it is headed. Cap is the President of Encore Insight LLC, a consulting and training service for FDA law and operations.

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