An electronic MDR or eMDR submission is nothing but a file with one or more medical device reports compiled in an electronic format, which the FDA can review, process, and archive.
1. Information needed in electronic MDR
21 CFR Part 803, the MDR regulation defines the types of reports and the data elements needed in an MDR. An eMDR also holds the same data elements. Importers must take into account the information specified in 21 CFR 803.42. Manufacturers need to include the details specified in 21 CFR 803.52. User facilities should contain the information specified in 21 CFR 803.32. Even though the eMDR Final Rule allows user facilities to carry on submitting MDRs on paper, user facilities might as an alternative choose to submit MDRs in an electronic format.
2. Format of an electronic MDR
The FDA's present data system has been developed for the purpose of processing, reviewing, and archiving MDRs configured according to the Health Level Seven Individual Case Safety Report message format. An MDR is comprised of data element identifiers and the associated data element value in a machine-readable format.
3. Filling up a field where you don’t have information
For all Health Level Seven (HL7) Individual Case Safety Reporting (ICSR) users, the HL7 ICSR schema offers numerous values that could be made use of when there is no information to enter in an optional field:
Asked But Unavailable- ASKU
These values, which are otherwise called “null values”, are added to the HL7 ICSR message to further clarify why data is not being supplied.
4. Acknowledging eMDR submission
The system in FDA automatically routes three forms of electronic acknowledgments to the ESG account of the user. These acknowledgements points out the eMDR’s stage of processing:
Acknowledgment 1indicates that the ESG got the eMDR(s), acknowledgment 2 specifies that CDRH received the eMDR(s) and acknowledgment 3specifies the pass or failure status of the eMDR(s) into the adverse event database of the CDRH.
5. Receipt date for an electronic MDR
According to the FDA, the date the eMDR arrived at the ESG is the receipt date for an eMDR.
6. Preserving a copy of the eMDRs/the acknowledgments
As per electronic MDR final rule, under 21 CFR 803.18(b)(1)(ii), an individual must preserve any paper or electronic copies of all reports submitted to the importers, manufacturers or distributers. A person must also keep copies of all the electronic acknowledgments sent by the FDA in response to the individual’s eMDRs.