Life Science companies that manufacture medical devices need to stay on the forefront of compliance with the latest regulatory requirements. Recently, the FDA laid out updated requirements for Electronic Medical Device Reporting (eMDR) submissions, with implementation timelines falling in the June 2018 timeframe. Some rules that have previously been optional are now being required, and the landscape of electronic submissions are now being expanded. Companies that currently use eMDR with their Quality Management Systems, such as TrackWise, should start evaluating and implementing these new requirements to maintain their compliant state.
Sparta Systems, the makers of TrackWise, is now in the process of implementing and releasing these new requirements in the TrackWise e-Reporting Utility, in an upcoming release prioritized by the timelines provided by the FDA. As Sparta is updating the tool, we are working with customers to evaluate the impact and changes required to their configuration, and collaboratively implement to meet the June 2018 timelines.
The following are the focus areas of the new requirements that should be addressed proactively.
- Reason for Blank
For a while, the FDA requested that blank fields include a reason why they are intentionally left blank, or a null flavor. As of October 2017, this is now a requirement to be included. To meet the new submission requirement, Reason for Blank (RFB) fields are added to the quality management system’s configuration, and subsequently, their values need to be mapped in the utility.
- Symptom and Evaluation Coding
To align with the coding schema for IMDRF in Europe, the FDA is implementing a new NCI Concept Codes for all coding fields. These new codes should be included now. The new schema can be found here.
- HL7 ICMR Release 2
By June 2018, the FDA will update the XML file schema for HL7 ICMR to Release 2. This release includes new fields for ethnicity and race, as well as all the Concomitant Drug Therapy (Section C) fields to now be included. If these fields apply to your organization and products, these need to be considered for addition.
- ASR Exception Summary Format
If your company has applied for and submits Alternative Summary Reports (ASR), these now have to be submitted electronically as an attachment on a specially formatted eMDR, including additional summary information in the eMDR and a Manufacturer’s Report Number in line with the rest of your eMDR submissions.
If your company uses an eMDR submission utility and is looking to pro-actively meet the 2018 FDA requirements for electronic submissions, consider implementing the best practices outlined above. Sparta Systems is releasing these changes soon, and it is in your interest to keep up with these changes.