For the second-consecutive week, Dr. D was able to dive into the often-treacherous waters known as FDA’s Warning Letter Database and extract another winner of a prestigious FDA warning letter pertaining to Medical Device Reports (MDRs), or should the doctor say lack thereof? Seriously, for those readers that have not yet connected the dots, the FDA appears to be on a mission to ensure device establishments accelerate their compliance with the eMDR process (Part 803). For those readers that have not had the opportunity to read last week’s Devine Guidance (DG), now would be a good time to do so. If an establishment’s Chief Jailable Officer (CJO) fails to provide an FDA investigator with documented evidence of compliance with Part 803 and the MDR requirements (including eMDRs), then future claims of actually having exculpatory (look-it-up) evidence will probably fall on deaf ears. Simply stated, if your establishment is not complying with eMDRs, well that ship has already sailed, so you better start swimming and swimming quickly. Enjoy!
Warning Letter –August 26, 2015
Similar to last week’s DG, although not specifically listed as an observation, the FDA included some compliance advice in the warning letter and the need to comply with the eMDR requirement. Considering the warning letter recipient mentioned in this week’s DG: (a) failed to properly process complaints in accordance with 820.198; (b) failed or refused to furnish material or information regarding their devices that is required by Section 519 of the Act; (c) failed to adequately develop, maintain and implement written MDR procedures as required by 21 CFR 803.17; (d) filed what appears to be late MDRs; and (e) provided the agency with less than stellar responses to the Form 483 observations; well, bad things are bound to happen, and they did. Trust old Dr. D when he says, “You need not possess a crystal ball or be clairvoyant to see this trainwreck coming.” That being said, the doctor is going to attempt to help my friends at FDA drive home a point and refer you to key elements from last week’s DG [I1] to reinforce salient elements associated with the eMDR process. Before you even think about it, Dr. D knows the agency does not need my help as they are perfectly capable of inflecting some serious pain (regulatory pain) on their own.
Review 21 CFR, Part 803 – Medical Device Reporting from last week’s DG here.
Compliance for Dummies
Dr. D received a few emails from some friends this past week (yes, the doctor has friends) informing Dr. D that they have had trouble with getting the FDA’s eMDR software to work. In fact, I know of three establishments where the CJO’s exercised their best judgements and submitted paper files; otherwise, their MDRs would have been late. If anyone from FDA is reading this week’s guidance, FYI your software definitely needs some tender loving care, because it is not working as advertised.
Now for those of you not familiar 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 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. For those of you unable to make that connection with FDA, you had better be sending paper copies, and you better be lighting up the phones at FDA.
For this week’s guidance, the doctor will leave just one takeaway for the readers. If you are unable to get the eMDR process to work, you had better mail paper copies of your MDRs (express mail with documented evidence of delivery), and follow up with a phone call to FDA. Dr. D is sure that the bugs will eventually be worked out. 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 26, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations, Cellestis, Inc.. Accessed September 9, 2015. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm461128.htm