Recently, the FDA released a final rule amending its postmarket medical device reporting regulation (21 C.F.R. Part 803), to stipulate that mandatory medical device reports (MDRs) be provided in “an electronic format that FDA can process, review and archive.” The original draft of the Final Rule was proposed on August 21, 2009. The most significant change between the proposed and Final Rule is that user facilities are not required, but are encouraged, to submit MDRs electronically.
Noting that the agency has received paper-based MDRs via mail for more than 20 years, the FDA says that the “final rule to require the electronic submission to FDA of manufacturer and importer MDRs is an important step toward improving the agency’s systems for collecting and analyzing postmarket MDRs.” Electronic MDRs (eMDRs) will be submitted to FDA’s existing Electronic Submissions Gateway (ESG) through either of two options: (1) FDA’s eSubmitter program or (2) Health Level Seven Individual Case Safety Reporting (HL7 ICSR) format.
The final rule is effective August 14, 2015. The agency indicates that “a manufacturer or importer needs to request and obtain an exemption from electronic reporting to continue to report via hardcopy past the effective date for electronic reporting.”
In an accompanying Federal Register notice, the FDA announced the availability of guidance, “Questions and Answers about eMDR – Electronic Medical Device Reporting – Guidance for Industry, User Facilities and FDA Staff,” that aims to “provide general information regarding how to prepare and send an electronic postmarket medical device report to the Center for Devices and Radiological Health,” as well as identify “where to find more detailed information on the preparation and transmission of the reports.”
I. Overview of the Final Rule
A. Changes to the 2009 Proposed Rule
The 2009 proposed rule included only the parts of the regulation that contained amended and changed language. The final rule contains part 803 in its entirety for ease of reading and clarity.
The 2009 proposed rule proposed to remove the definition for “Five-day report” from § 803.3 as unnecessary since it merely referred to a report under § 803.53. Because there is still a requirement for 5-day reports, FDA has concluded that removing the definition could be confusing to reporting entities and have decided to retain the definition.
The 2005 plain language MDR direct final rule removed the enumeration of definitions under § 803.3. Subsequent difficulties when referencing specific definitions have suggested that FDA should reinstitute numbering the definitions and have done so in this final rule. Certain terminology used in the proposed rule has changed in the final rule. References to CeSub (CDRH eSubmitter) have been revised to reflect the current FDA-wide term used for electronic submissions, eSubmitter.
In addition, under this final rule, a manufacturer or importer needs to request and obtain an exemption from electronic reporting to continue to report via hardcopy past the effective date for electronic reporting. The 2009 proposed rule used the term “variance” at the end of section § 803.19(b), but FDA has concluded that “exemption” more accurately describes the reporting change and have therefore used the term “exemption” in the final rule. FDA’s existing guidance for requesting exemptions applies to such requests.
B. Highlights of the Final Rule
For over 20 years, FDA received postmarket MDRs in a paper format through the mail. In 2008, FDA permitted manufacturers to submit postmarket MDRs electronically, on a voluntary basis. This final rule to require the electronic submission to FDA of manufacturer and importer MDRs is an important step toward improving the Agency’s systems for collecting and analyzing postmarket MDRs. When manufacturers and importers submit data elements to FDA in a paper format, the information must be manually entered into our internal electronic database before it can be effectively reviewed and analyzed. Under the proposed rule, this data entry will be performed by the manufacturers and importers and they will save the cost of submitting the paper forms. More importantly, eliminating that step will make the information available more quickly to FDA.
This final rule includes reports of deaths, serious injuries, and malfunctions that must be reported to FDA in initial 5-day, 10-day, or 30-day individual MDRs as well as information that must be reported to FDA in supplemental or followup reports. It does not change the underlying reporting requirements, just the manner in which they are submitted to FDA. This final rule will have the following benefits:
- Reducing industry’s time and costs associated with transcribing data from internal data management systems to paper and mailing the paper reports to the Agency;
- Reducing the Agency’s transcription errors, time, and costs associated with receiving paper reports and transcribing data to electronic format for review and analysis;
- Expediting the Agency’s access to safety information in a format that supports efficient and comprehensive data analysis and reviews; and
- Enhancing the Agency’s ability to rapidly communicate information about suspected problems to the medical device industry, health care providers, consumers, and other government Agencies.
C. How Do I Submit MDRs in Electronic Format?
Upon the effective date of this final rule, manufacturers and importers are required to submit MDRs to the Agency in an electronic format that FDA can process, review, and archive. The most specific and updated information about how to create, format, and transmit reports electronically using the eSubmitter software (for low volume reporting) or the Health Level Individual Case Safety Reports (HL7 ICSR) (for high volume reporting), is provided on the Agency’s Web site at the address identified in the new § 803.23. FDA is committed to providing industry with adequate notice of any specifications changes. To the extent possible, FDA will ensure previous versions of such specifications can still be utilized to submit adverse events electronically.
D. How Have the MDR Requirements Changed?
1. What Has Changed for User Facilities and Has Annual Reporting Been Affected?
Section 803.30(a) requires user facilities to report information required by § 803.32 in accordance with § 803.12(b). User facility reports submitted to device manufacturers may also be in paper format or an electronic format that includes all required data fields to ensure that the manufacturer has all required information. Since user facilities will continue to submit annual reports on the paper Form FDA 3419, the rule amends § 803.33 to specify where to obtain the Form FDA 3419 and where to submit completed annual reports.
2. What Has Changed for Importers?
The rule amends § 803.40(a) to require submission to FDA of information required by § 803.42 in electronic format in accordance with § 803.12(a). The mandatory electronic format requirement does not apply to importer reports submitted to device manufacturers, which may be in paper format or an electronic format that includes all required data fields to ensure that the manufacturer has all required information.
3. What Has Changed for Manufacturers?
The rule amends §§ 803.50(a), 803.53, and 803.56 to require submission of MDR and supplemental report information required by §§ 803.52, 803.53, and 803.56 in electronic format in accordance with § 803.12(a).
4. Are There Changes for Recordkeeping?
Section 803.18 contains requirements for establishing and maintaining MDR files or records for manufacturers, user facilities, and importers. The rule amends § 803.18(b)(1)(ii) to require keeping copies of all reports submitted under part 803, whether paper or electronic. (Regulated entities may choose to maintain required records, including copies of all reports, either in hardcopy or in electronic form). FDA is also adding § 803.18(b)(1)(iii), to require the retention of all acknowledgments that FDA sends the manufacturer, importer, or user facility in response to electronic MDR submissions.
5. What Other Changes Are In This Final Rule?
The final rule does the following:
- Amends §§ 803.32, 803.42, and 803.52 to reflect the addition to the Form FDA 3500A of a question whether the device is a single use device that has been reprocessed and reused on a patient and, if so, asking for the name and address of the reprocessor (these modifications were already made to Form FDA 3500A and its instructions, with Office of Management and Budget (OMB) approval under the Paperwork Reduction Act (PRA));
- Changes language in §§ 803.32(b)(4), 803.42(b)(4), and 803.52(b)(4) from “date of report by the initial reporter” to “[d]ate of this report,” to make part 803 consistent with the way that other FDA Centers interpret Form FDA 3500A, Block B4, and how Block B4 appears on Form FDA 3500A; and
- Makes minor updates to §§ 803.32(c), 803.42(c), and 803.52(c) and (e) to reflect the changes already made to the forms and instructions, including references to the Product Code and PMA/510(k) number.
II. Questions and Answers about eMDR – Electronic Medical Device Reporting – Guidance for Industry, User Facilities and FDA Staff
What is an electronic MDR submission?
For the purposes of this guidance, an eMDR submission is a file containing one or more medical device reports in an electronic format that FDA can process, review, and archive.
What information do I need to include in my electronic MDR?
The MDR regulation (21 CFR Part 803) specifies the types of reports and the data elements required in an MDR. An eMDR contains the same data elements. Importers must include the information specified in 21 CFR 803.42. Manufacturers must include the information specified in 21 CFR 803.52. User facilities must include the information specified in 21 CFR 803.32. Although the eMDR Final Rule permits user facilities to continue to submit MDRs on paper, user facilities may instead choose to submit MDRs in an electronic format.
What is the format of an electronic MDR?
FDA’s current data system was developed to process, review, and archive MDRs configured according to the Health Level Seven Individual Case Safety Report (HL7 ICSR) message format. An MDR is made up of data element identifiers and the associated data element value in a machine-readable format. For specific information on data element identifiers used by both of the reporting options discussed below, see the Health Level Seven (HL7) Individual Case Safety Report (ICSR) Release 1: Implementation Guide for FDA Medical Device Reporting.
B. Sending an Electronic MDR Submission via FDA’s Electronic Submissions Gateway (ESG)
What do I need to do to start submitting MDRs electronically to FDA?
To submit MDRs electronically, you will need to set up a Web Trader Account and then submit test data that is successfully processed through the ESG before you receive a production account to use for your MDR submissions. Here is the process for beginning to file eMDRs:
- Request a Web Trader Account from the ESG.
- Submit a Letter of Non-Repudiation to FDA.
- Obtain a personal digital certificate.
- Submit test data. Prepare a test eMDR (a mock report and not an actual adverse event report) containing the information specified in the appropriate section of 21 CFR Part 803: 803.32 for user facilities, 803.42 for importers, or 803.52 for manufacturers.
- Receive a production account from the ESG. CDRH will notify ESG to provide you with the production account once you have completed successful testing.
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Use the production account to send your actual eMDRs to FDA.
Detailed instructions can be found at: Setting up a WebTrader Account Checklist
Additional information about the ESG is available at: Electronic Submissions Gateway.
How do I prepare an electronic MDR submission?
You can choose from two options to create your eMDR submission. More information on the two options for filing eMDRs is available at: Electronic Medical Device Reporting (eMDR).
1. FDA eSubmitter (formerly referred to as CDRH eSubmitter or CeSub) Software
The eSubmitter program is a free, downloadable application that allows users to create one report at a time. With eSubmitter, the user manually enters the required MDR information into the eSubmitter program. The program contains data elements that correspond with 21 CFR 803.32, 803.42, and 803.52, and generates the .xml message, in HL7 ICSR format, needed to successfully transmit the report via the ESG.
The eSubmitter program allows the user to print a copy of the submitted report(s) and allows the attachment of labeling or other documents to the initial report or to a supplemental or follow-up report.
The eSubmitter program and installation instructions are free and available at: eSubmitter Download and Installation.
2. Health Level Seven (HL7) Individual Case Safety Reporting
This option provides the capability to create and submit eMDRs either individually or in batches (containing multiple individual reports in a single submission). Entities who choose this option are encouraged to develop systems that can save or print the resultant report and that can encode attachments into their eMDRs.
You can find more detailed information on these two methods of preparing an eMDR at: eMDR – Electronic Medical Device Reporting.
How should I complete a data field (a field where a user can type information) if I do not have information for the field?
For Health Level Seven (HL7) Individual Case Safety Reporting users, the HL7 ICSR schema provides for several values that may be used when there is no information to enter in an optional field:
- ASKU – asked but unavailable
- NI – no information
- NA – not applicable
These “null values” are added to the code of the HL7 ICSR message to further clarify why data is not being provided. Information on how to properly implement null values is found at: Health Level Seven (HL7) Individual Case Safety Reporting (ICSR) Files. (At that site, click the link for “Complete Packet: eMDRHL7files.zip” and select the ICSR Implementation Technical Specification document, which answers the question “How do I address null values?”).
For eSubmitter users, if you have no information to provide for a given data field, and eSubmitter does not allow the selection of a null value for that field, you should leave the field blank.
How do I know if my submission of an electronic MDR was successful?
FDA’s system will automatically route three separate electronic acknowledgments to the user’s ESG account. These acknowledgements indicate the stage of processing that the eMDR has reached:
- Acknowledgment 1, also known as the Receipt or MDN (Message Disposition Notification) acknowledgment, indicates that the ESG received the eMDR(s).
- Acknowledgment 2 indicates that CDRH received the eMDR(s).
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Acknowledgment 3 indicates the pass or failure status of the eMDR(s) into CDRH’s adverse event database–that is, whether the eMDR was successfully loaded into the database.
If there are no errors, FDA anticipates that the three acknowledgement letters will be generated the same day or within 24 hours of the submission.
What date does FDA consider the receipt date for an electronic MDR?
FDA considers the receipt date for an eMDR to be the date the eMDR arrived at the ESG (Acknowledgment 1), but only if the eMDR is successfully loaded in the CDRH database (a passing Acknowledgment 3). If a failure occurs during the validation or loading process, the error is described in Acknowledgment 3. The reporting entity should correct the error(s) and resubmit the eMDR. If the resubmitted eMDR is successfully loaded, (a passing Acknowledgment 3), the receipt date will be the date that the resubmitted eMDR arrived at the ESG, as documented in the Acknowledgment 1 issued for the resubmitted eMDR.
The time zone should not be a concern for timely reporting under MDR. Although Acknowledgment 1 displays both the date and time according to the Eastern Standard Time (EST)/Eastern Daylight Time (EDT) zone, MDR considers only the date for the purposes of calculating timely reporting. If the report is successfully loaded, this processing should take no more than an hour. Although Acknowledgment 1 displays EST/EDT, FDA will consider the local time of the submitter when determining the submission date, just as a postmark date is used for mailed paper reports.
What should I do if Acknowledgment 3 notifies me of validation and loading error(s) in my electronic MDR?
If you submit an eMDR individually (not as part of a batch), and receive an Acknowledgment 3 that states that your report has failed to load, the Acknowledgment 3 will describe the error(s). You should correct the error(s) and resubmit the eMDR, at which time you will receive another set of three acknowledgments.
If you submit an eMDR as part of a batch, Acknowledgment 3 will list all the reports in the batch and indicate whether each report has passed or failed to load. You should correct the error(s) for the failed reports and resubmit the FAILED reports ONLY. You should not resubmit the entire original batch. When you resubmit the report(s) that contained errors, you will get another set of three acknowledgments for the resubmitted eMDR(s).
Errors that will prevent successful loading in the CDRH database of an eMDR include:
- Failure to provide data in a required data field, such as the report number,
- Failure to use the appropriate format for a data field, such as an incorrect date format,
- Invalid report number error: Use of an invalid report number (i.e., not following the correct format for the number or using an incorrect number for the reporting entity),
- Character max error: Too many characters entered, exceeding the character limitations for a given data field,
- Duplicate report error: Caused when a reporting entity submits a report that was previously loaded successfully into the CDRH database, and
- Initial report not found for this supplemental error: Caused when a user submits a supplemental report to an initial report that has not been accepted in the CDRH database.
If you need help interpreting error messages in Acknowledgment 3, send an e-mail to eMDR@fda.hhs.gov.
What should I do if I send my eMDRs and do not receive one or more of the acknowledgments?
If you do not receive Acknowledgment 1 or 2, check the status of the ESG at: Electronic Submissions Gateway (ESG) – System Status. If the ESG system status website indicates the ESG is operating normally, contact the ESG Staff at esgreg@gnsi.com.
If you do not receive Acknowledgment 3, check the eMDR Status Page. If the eMDR system status website indicates that eMDR is operating normally, contact eMDR@fda.hhs.gov.
Should I keep a copy of the eMDRs that are in my electronic MDR submission? Should I keep the acknowledgments?
Yes, under 21 CFR 803.18(b)(1)(ii) of the eMDR Final Rule, an entity is required to keep paper or electronic copies of all reports submitted to us or to importers, distributors, or manufacturers. In addition, under 21 CFR 803.18(b)(1)(iii) of the eMDR Final Rule, an entity must keep copies of all electronic acknowledgments sent by FDA in response to the entity’s eMDRs.
C. Supplemental, Follow-up, and Additional Information Submissions
How do I update a report?
Under 21 CFR 803.12 of the eMDR Final Rule, manufacturers and importers must submit supplemental or follow-up reports to FDA in an electronic format that FDA can process, review and archive. User facilities may submit follow-up reports to FDA in an electronic format, but are still allowed to report only on paper in accordance with 21 CFR 803.12(b).
The options for preparing and transmitting a supplement or follow-up report are the same as those for initial reports, discussed above. For all updates, you should include the initial report number and state that the type of submission is a follow-up report. Limit your additional entries to those where you need to update previously provided information. For example, if patient age and sex are unchanged, do not include them in your supplement or follow-up report. If you are updating or correcting the model number, provide the corrected information only. A submitter should use electronic submissions for supplemental or follow-up reports even for MDRs that were initially filed on paper.
Can a reporting entity respond to an FDA Request for Additional Information (AI) electronically?
If FDA requests additional information for an MDR under 21 CFR 803.15, you are encouraged to submit the response electronically.
A manufacturer responding to an FDA request for additional information, using the 3500A format, should enter the initial report number, indicate in Block H2 that the type of follow-up is a “Response to FDA Request,” and provide the requested information in Block H10/11, Additional Manufacturer Narrative. Any discrete data elements should also be reported in Block H10/11. You may submit the letter you received as an attachment to the submission.
The FDA request for AI may give the manufacturer the option to respond using email to the FDA sender. The manufacturer’s email response should include the identifying information specified in the AI request.
A communication from FDA to a user facility or importer that requests additional information will provide instructions for responding to the sender. That response should include the identifying information specified in the AI request.
D. Communication about Software Changes and System Outages
How will I learn of future changes to software, data fields and code lists?
FDA is committed to providing industry with adequate notice of any specification changes and, when possible, will ensure previous versions of such specifications can still be utilized to submit adverse events electronically. FDA will utilize our websites for MDR, eMDR, and FDA ESG as well as Federal Register notices and updates to this guidance (when appropriate) to provide sufficient advance notification of changes to all stakeholders. FDA will work with stakeholders on implementation of the changes and expect to support previous specifications long enough to ensure that HL7 and eSubmitter users are able to make the necessary changes.
What should I do if a System Outage prevents me from filing an electronic MDR on time?
The FDA ESG website provides notification of scheduled maintenance and maintains a status history that documents unscheduled down time for the FDA ESG. The CDRH eMDR website provides notification of scheduled maintenance for the CDRH eMDR processing system. Typically, an ESG or CDRH eMDR processing system outage will not last more than 24 hours and should not require an extension of time. However, if a manufacturer or importer is unable to submit a report on time due to an outage affecting the ESG or the CDRH eMDR processing system, it may document its attempts at timely filing in Block H10 for the affected reports and submit reports electronically as soon as the ESG or CDRH eMDR processing system is operational.
A reporting entity using an HL7 reporting option should plan for a backup method of reporting for an outage affecting its own system. If a reporting entity experiences an outage within its own system that will affect timely reporting, it should contact FDA at the eMDR email address, eMDR@fda.hhs.gov. The email should provide FDA with information on the problem, the number of reports affected, and an estimate of how long it will take to resolve. FDA will respond to provide instructions on alternatives for submission of the adverse event reports. A description of the problem with the electronic submission should be documented in Block H10 for the affected reports before they are submitted.
When an alternative method is used during a system outage, FDA will respond with an Acknowledgment 3 that documents that the report has been successfully loaded in the CDRH database or failed to load due to specified errors. In these instances, the reporting entity will not receive an Acknowledgment 1 or 2.
E. Additional Sources of Information
Where can I find technical information concerning the eSubmitter software?
Technical information, e.g., information on downloading the software, on the eSubmitter system is accessible ateSubmitter Download and Installation.
Where can I find technical information concerning the HL7 ICSR?
Technical information, including technical specifications, on the HL7 ICSR is accessible at Health Level Seven (HL7) Individual Case Safety Reporting
Who do I contact if I cannot find the answer to my question?
For general questions on eMDR submissions, e-mail eMDR@fda.hhs.gov. For questions concerning the FDA Electronic Submissions Gateway (ESG), please contact the ESG staff as indicated on their Web site.
For questions about the MDR regulation and reporting, you may call 301-796-6670 or send an email toMDRPolicy@fda.hhs.gov