Dr. D hopes the readers living in the United States enjoyed their Labor Day weekend. The doctor has thoroughly enjoyed three days of drinkin’ and thinkin’. As a result of these efforts and a quick dive into the agency’s warning letter database, Dr. D will write briefly about electronic medical device reporting (eMDR) for this week’s Devine Guidance (DG). As all of the readers should already be well aware, the requirement for electronic reporting of MDRs formally went into effect on August 14, 2015. For those unaware of this change, it is now time to emerge from your caves. The doctor strongly suggests reading the guidance initially issued by FDA in February 2014, “Questions and Answers about eMDR – Electronic Medical Device Reporting – Guidance for Industry, User Facilities and FDA Staff.” This guidance document gets into the proverbial weeds in regards to eMDR requirements. Additionally, a re-read of 21 CFR Part 803 might be a valuable refresher. For establishments not complying with the most current version of Part 803, there is no time like the present to achieve compliance. Please remember when FDA investigators appear in your lobby for a cup of coffee and an inspection, they will have little patience for Chief Jailable Officers (CJOs) who fail to achieve compliance with all FDA requirements (including Part 803), and are nothing more than sycophants (look-it-up). Enjoy!
Warning Letter –August 7, 2015
Although not specifically listed as an observation, the FDA included some compliance advice in observation four (note: incorrectly numbered as a repeat observation number one in the warning letter) noted in the warning letter excerpt pasted into this week’s DG. There were multiple issues already cited in observation four relating to a Medical Device & Vigilance Reporting. For example, the procedure is: (a) missing key definitions; (b) missing the FDA’s mailing address for MDRs; (c) missing any mention of eMDRs; and (d) actually includes the requirement for baseline reporting, which was suspended in 2008. Ouch! Considering the FDA really doesn’t mind if device establishments shamelessly plagiarize the regulations, there is never going to be a valid excuse for not having a compliant SOP.
Observation Four (4) – “Failure to develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17.
A. Your “Medical Device & Vigilance Reporting”, procedure Revision 1, dated May 22, 2013, does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. Specifically,
- There are no definitions of what your firm will consider to be a reportable event under 21 CFR Part 803. The exclusion of definitions from 21 CFR 803.3 for the terms “become aware,” “caused or contributed,” “malfunction,” “MDR reportable event,” and “serious injury,” and definitions for the terms “reasonably known” and “reasonably suggests,” found respectively in 21 CFR 803.50(b) and 803.20(c)(1) may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).
B. Your “Medical Device & Vigilance Reporting”, procedure Revision 1, dated May 22, 2013, does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the following are not addressed:
- How your firm will submit all information reasonably known to it for each event.
- The procedure does not include the address for where to submit MDR reports: FDA, CDRH, Medical Device Reporting, P. O. Box 3002, Rockville, MD 20847-3002. Your firm’s procedure includes references to baseline reports. Baseline reports are no longer required and we recommend that all references to a Baseline Report be removed from your firm’s MDR procedure (see: 73 Federal Register Notice 53686, dated September 17, 2008).
The eMDR Final Rule requiring manufacturers and importers to submit electronic Medical Device Reports (eMDRs) to FDA was published on February 13, 2014. The requirements of this final rule will take effect on August 14, 2015. If your firm is not currently submitting reports electronically, we encourage you to visit the following web link for additional information about the electronic reporting requirements: http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm. If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the Reportability Review Team by email at ReportabilityReviewTeam@fda.hhs.gov”.
21 CFR, Part 803 – Medical Device Reporting
§803.11 – What form should I use to submit reports of individual adverse events and where do I obtain these forms?
“(a) If you are a manufacturer or importer, you must submit reports of individual adverse events to FDA in an electronic format in accordance with §803.12(a) and §803.20, unless granted an exemption under §803.19.
(b) Importer reports submitted to device manufacturers may be in paper format or an electronic format that includes all required data fields to ensure that the manufacturer has all required information.
(c) If you are a user facility, you must submit reports of individual adverse events in accordance with §803.12(b) and §803.20.
(d) Form FDA 3500A is available on the Internet at http://www.fda.gov/medwatch/getforms.htm or from Division of International and Consumer Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4621, Silver Spring, MD 20993-0002, by email: DICE@fda.hhs.gov, FAX: 301-847-8149, or telephone: 800-638-2041.
§803.12 – How do I submit initial and supplemental or follow-up reports?
(a) Manufacturers and importers must submit initial and supplemental or follow-up reports to FDA in an electronic format that FDA can process, review, and archive.
(b) User facilities that submit their reports and additional information to FDA electronically must use an electronic format that FDA can process, review, and archive. User facilities that submit their reports to FDA on paper must submit any written report or additional information required under this part to FDA, CDRH, Medical Device Reporting, P.O. Box 3002, Rockville, MD 20847-3002, using Form FDA 3500A. Each report must be identified (e.g., “User Facility Report” or “Annual Report”).
(c) If you are confronted with a public health emergency, this can be brought to FDA’s attention by contacting FDA’s Office of Crisis Management, Emergency Operations Center by telephone, 24-hours a day, at 301-796-8240 or toll free at 866-300-4374, followed by the submission of an email to: email@example.com.
Note: This action does not satisfy your obligation to report under part 803.
(d) You may submit a voluntary telephone report to the MedWatch office at 800-FDA-1088. You may also obtain information regarding voluntary reporting from the MedWatch office at 800-FDA-1088. You may also find the voluntary Form FDA 3500 and instructions to complete it at: http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm.
Compliance for Dummies
Now for those of you who are unfamiliar with the eMDR process, you will have so much fun setting up the accounts for your establishments. To give you a small taste of what setting up the eMDR process entails, the doctor has stolen shamelessly from the FDA guidance document and pasted it into this week’s DG for the reader’s personal edification.
“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.
- Use the production account to send your actual eMDRs to FDA.”
When attempting to get the bugs out of your eMDR process and becoming familiar with the tiny little nuances associated with the FDA’s eMDR process, patience is the key, my dear readers. However, once you have established your accounts with FDA and the eMDRs start flowing to the agency (hopefully not too many MDRs), the initial patience and practice will drive proficiency. Additionally, Dr. D suggests that device manufacturers establish stand-alone SOPs for eMDRs and Vigilance due to the significant differences in the United States versus the European Union.
For this week’s guidance, the doctor will leave just one takeaway for the readers. One: If you are reading this week’s guidance and asking yourself what in the heck is an eMDR, well it’s never too late to quickly work toward compliance. You can take it to the proverbial bank: FDA will write Form 483 Observations when it comes across establishments that fail to comply with the eMDR process, including a procedure that actually fails to reference the eMDR process. In closing, thank you again for joining Dr. D, and I hope you find value in the guidance provided. Until the next installment of DG, cheers from Dr. D. and best wishes for continued professional success.
- Code of Federal Regulation. (April 2015). Title 21, Part 803: Medical device reporting. Washington, D.C.: U.S. Government Printing Office.
- Code of Federal Regulation. (April 2015). Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office.
- Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
- Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon.
- FDA. (August 7, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations, Cardiac Designs, Inc. Accessed September 5, 2015. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm459656.htm