eMDR System Enhancements
March 9, 2023On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time. Those who use eSubmitter will notice changes in the electronic 3500A template in the first week of March.
Background
FDA first introduced the final rule and guidance on eMDR in 2014, which we blogged about here. Since the final rule took effect on August 14, 2015, medical device manufacturers and importers have been required to submit MDRs in an electronic format. User facilities are not required, but have been encouraged, to submit MDRs electronically. The eMDR requirements pertain to initial and supplemental MDRs and follow-up reports. Additional information responses for an MDR were also encouraged to be submitted electronically.
eMDR submissions can be submitted in one of two ways: Health Level 7 Individual Case Safety Reports (HL7 ICSR) via AS2 (for high volume reporting) or by using FDA’s eSubmitter software (for low volume reporting). The HL7 ICSR option extracts information directly from the reporter’s database to populate the eMDR. The eSubmitter software generates an electronic version of Form 3500A, the form for use by user facilities, importers, distributors and manufacturers for mandatory reporting.
Either way, the information is transmitted to FDA via the ESG. Once the eMDR is submitted through the ESG to FDA, three separate acknowledgement messages are sent to the submitter. These messages are to be maintained as part of the file per 21 C.F.R. § 803.18(b)(1)(iii). Acknowledgment 1 indicates that the submission was received at the ESG. Acknowledgement 2 indicates that the submission reached CDRH. Acknowledgement 3 notifies the submitter that the submission was either successfully loaded into CDRH’s adverse event database or that the submission contained errors, which will be specified in the letter. If errors are identified, the submitter will need to correct the file and re-submit. If there are no issues, the submitter can expect all three acknowledgement letters either on the same day or within 24 hours of the submission.
Updates
The eMDR system will be updated to not accept reports:
- That provide a Patient Age but do not provide the patient age unit in the A2 section of the form;
- That do not identify the Product Code in the D2b section of the form;
- Where the “implant date” (D6a) is after the “explant date” (D6b), if both dates are provided;
- That do not include Adverse Event Problem codes in H6 (for manufacturers) or F10 (for distributors and importers); specifically Medical Device Problem Code and Health-Effect Clinical Code;
- That do not provide a contact email address in G1 (for manufacturers) or F3 (for distributors and importers). (This should serve as a reminder to submitters to carefully review their MDRs ahead of submission.)
In all of the above instances, submitters will receive a rejection message in Acknowledgement 3 describing the error or missing information. Test deployment for the changes listed above were deployed to eMDR on August 19, 2022 and will be deployed to production on March 17, 2023.
The Adverse Event codes accepted in sections F10 and H6 of the 3500A form will be updated to harmonize with maintenance updates from the International Medical Device Regulators Forum (IMDRF). This was deployed to pre-production on August 19, 2022 and implemented in eMDR and eSubmitter the same day.
To provide early notice and predictability about potential eMDR system changes, FDA is adopting a yearly schedule announcing and implementing enhancements to the eMDR system:
- Announce upcoming enhancements in June,
- Release the implementation package in August,
- Deploy enhancements to pre-production (ESG Test) also in August, and
- Deploy enhancements to production in March of the following year.
Although FDA intends to follow this schedule, emergency fixes may be implemented outside of the schedule. For any major changes, additional time will be granted between the release of the implementation package and production deployment.
To stay up to date with changes or review ones that have been implemented, refer to the regular communications, which can be found here.