Folks, I know Dr. D has written about failing to comply with Part 803 (Medical Device Reporting), on multiple occasions. You see, FDA actually frowns down upon organizations that are manufacturing finished medical devices, which have the potential to result in patient harm (including death) and their failure to report adverse events when they occur. After all, Part 803 is pretty explicit when it comes to identifying reporting requirements and delineating the basics such as who, what, where, when, how, and why.
Remember, the agency has never been accused of being “timorous” (look-it-up) when doling out warning letters to organizations that fail to comply with regulatory and statutory requirements. However, the agency gets particularly “snickered” (look-it-up) when a device establishment fails to file MDRs for obvious adverse events. Couple the failure to report MDRs with the lack of an established procedure(s) and the end-result is the issuance of a warning letter. This is FDA’s way of expressing a very simple idea; “Can you hear us now?”
To the dismay of Dexcom, Inc., the agency was truly unimpressed by this organization’s failure to file MDRs in a timely fashion, or in this case just not filing MDRs. The agency’s response was no surprise. FDA issued a warning letter. Please note: the entire warning letter was premised around a salient failure of the Dexcom Quality Management System (QMS), a failure to comply with 21 CFR, Part 803. With the agency’s warning letter comes an entirely new level of fun for the Chief Jailable Officer (CJO). Enjoy.
FDA Warning letter dated – 14 March 2014
Folks, Dr. D would like to remind the readers that failing to file MDRs is the equivalent of committing a mortal sin in the eyes of FDA. Failing to establish a written procedure is the equivalent of failing to obey one of FDA’s basic commandments. In each case, no good can come out of a device establishment’s failure to comply with regulatory and statutory requirements. In the case of Dexcom, the doctor has taken the liberty of cut-and-pasting key elements extracted from their warning letter awarded on the 14th of March. Strike one – failure to report within 30-days when a death or serious injury has occurred; Strike two – failure to report within 30-days for a device malfunction that results in a death or serious injury; and Strike three – not having an established procedure. Simply stated; “Ouch – you’re out!”
1. Failure to report to the FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that your firm’s device may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1).
2. Failure to report to the FDA no later than 30 calendar days after the day your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that it markets has malfunctioned and this device or similar device that your firm markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR Part 803.50(a)(2).
3. Failure to adequately develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17. For example, after reviewing your firm’s MDR procedure titled: MDR Procedure titled U.S. Medical Device Reporting, SOP-300024 Rev: 06 and Flow Chart titled: MDR Reporting Decision Record FTSOP-140202 Rev: 07, the following deficiencies were noted:
(1) The procedure does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. For example:
a. There is no evidence that SOP-300024 Rev: 06 and FTSOP-140202 Rev: 07 have been implemented. For example, there is no effective date for your firm’s MDR procedure and Flow Chart.
b. The procedure omits the definitions of the terms “becomes aware,” found in 21 CFR 803.3, and “reasonably known” and “reasonably suggests,” found respectively in 21 CFR 803.50(b) and 803.20(c)(1). The exclusion of the definitions for these terms from the procedure 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).
(2) The procedure does not establish internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under this part. For example:
a. There are no instructions for conducting a complete investigation of each event and evaluating the cause of the event.
b. The procedure, as written does not specify who makes the decision for reporting events to FDA.
c. There are no instructions for how your firm will evaluate information about an event to make MDR reportability determinations in a timely manner.
(3) The procedure does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the following are not addressed:
a. Instructions for how to obtain and complete the FDA 3500A form.
b. 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.
c. The circumstances under which your firm must submit supplemental reports and the requirements for such reports.
(4) The procedure does not describe how your firm will address documentation and record-keeping requirements, including:
a. Information that was evaluated to determine if an event was reportable.
b. Systems that ensure access to information that facilitates timely follow-up and inspection by FDA.
In addition, procedure SOP-300024 Rev: 06, includes references to baseline reporting and annual certification, which are no longer required. We recommend that all references to Baseline Reports and Annual Certification be removed from your firm’s MDR procedure (see: 73 Federal Register Notice 53686, dated September 17, 2008; and Fourth Notice, Federal Register, dated March 20, 1997: Medical Device Reporting, Annual Certification, Final Rule, respectively).”
MDRs – What you need to know
For the manufacturers of finished medical devices, you have two requirements you need to be keenly aware of: (a) 30-day reporting (note: calendar days); and (b) 5-day reporting (note: working days). Please note; the proverbial meter starts running when you or one of your employees becomes aware of a reportable event (i.e., death or serious injury). If the adverse event: (a) “necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health; or (b) the agency makes a written request for MDR submission, the 5-day reporting requirement comes into effect. Remember, in the eyes of FDA, a reportable event consists of:
- A finished medical device that “may have caused or contributed” to a patient death or serious injury; and/or
- A finished medical device that has malfunctioned that is likely to cause a death or serious injury, if the malfunction were to reoccur.
When such adverse events do occur; and trust Dr. D when the doctor says; “adverse events will eventually occur as there is no finished medical device utopia;” certain tiny little pieces of information are needed to complete the MDR process. For starters, Dexcom included, device establishments are required to collect as much information as possible about the adverse event and report the information to the agency using FDA Form 3500A or electronically, which will be mandatory in August of 2015 (read March 05, 2014 edition of Devine Guidance on eMDRs).
Additionally, FDA actually expects device manufacturers to perform investigations for MDR reportable events. Furthermore, if additionally information becomes available after the initial MDR has been filed, device manufacturers are required to file a supplemental report within 30-days of the additional information becoming available. Finally, there are specific pieces of information the agency expects to receive as part of the MDR process.
Required MDR information
As a minimum, FDA expects the following pieces of information, if available, to be included in the MDR. The best advice the doctor can offer is to honor the wishes of FDA and obtain the information. Why? Because the CJO really does not want to explain during a friendly FDA visit for a cup of coffee and an inspection as to why the MDRs are void of critical information. According to Part 803, the following tidbits of information should be considered for inclusion into each MDR:
- Basic patient information (name/identifier, age, gender, and weight);
- Description of the adverse event (problem, outcome(s), date of event, date of report, description of event, relevant tests, and other pertinent information);
- Device information (device name, type, reporting person’s name and address, operator of device, expiration date, model number, dates of implantation and explanation, availability of device for investigational purposes, and “concomitant” (look-it-up) medical products);
- Initial reporter information (name, address, and telephone number, reporter’s profession, occupation, and if the reporter also filed a MDR);
- Reporting information (basic contact information, telephone number, source of the report, date information received, type of report being filed, and report number); and
- Device manufacturer information (type of reportable event, type of follow-up report, summary of device investigation, device date of manufacture, is device labeled for single use, FDA evaluation codes (reference FDA MEDWATCH Medical Device Reporting Code Instructions), remedial action pursued, removal or correction pursued, additional information (as appropriate); actual use of device (initial, reuse or unknown), and corrected information being provided, as applicable).
Please keep in mind, if an adverse event occurs outside of the United States and the device is also entered into commerce in the United States, the FDA expects that a MDR decision tree be completed. If deemed worthy (premised on the decision tree), the adverse event must be reported as an MDR in the United States. Failure to do so will result in the wrath of FDA, when they find out; and trust the doctor when I say; “Eventually the FDA will find out!”
For this week’s guidance, the doctor will leave the readers with just one takeaway. Don’t be that organization that fails to file MDRs. As you can see from this week’s guidance, the FDA takes the need to report adverse events very seriously. In fact, seriously enough to move directly to warning letter if a device establishment fails to file MDRs. It is already considered an egregious violation of the regulation not to file MDRs within 30-days or 5-days, as appropriate. However, failing to file MDRs (period) is a mortal sin in the eyes of FDA.
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. (2013, April) Title 21 Part 803: Medical device reporting. 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.
- FDA’s enforcement page. (2014, April). FDA.gov Website. Retrieved March 31, 2014, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm390797.htm.