Device establishments wishing to enter finished devices into the commercial market in the United States should understand that 21 CFR, Part 803 (Medical Device Reporting) is a salient requirement. Hopefully, most of the readers realize that the FDA instituted an electronic reporting requirement appropriately entitled eMDR. The official notification was published in the Federal Register on February 14, 2014, with a go-live date of August 13, 2015. Establishments wishing to file MDRs manually were required to apply for an exemption. Now Dr. D clearly understands the trials and tribulations associated with the agency’s eMDR software and the steps required for gaining access to the Electronic Submission Gateway (ESG). The process for establishing a WebTrader account necessary for using the e-submitter process is quirky (Dr. D’s opinion). In fact, every establishment with whom I have spoken, since the inception of the eMDR process, has experienced some level of pain (or horror story) associated with gaining access and filing their first eMDR. For those of you who receive the FDA’s ESG status updates, at times this system seems to be down more times than it is up. But hey, in the United States, filing eMDRs is now the law so all the old doctor will say is get over it and deal with it. Now for you Chief Jailable Officers (CJOs) currently playing in the FDA’s sandbox, Dr. D knows you never want to be sitting across from an investigator of the FDA during an inspection with a gaping hole in your quality management system (QMS) (i.e., for something such as not having a procedure for MDRs). No CJO wants to be on the receiving end of a ticked-off investigator’s vocal depredation (look-it-up) of his or her QMS. Those types of inspections are never fun and almost always end badly for the offending establishment. Enjoy!
Warning Letter – July 12, 2017
In reviewing this week’s warning letter database, it appears our dear friends from the agency are continuing with the mass depredating(look-it-up again) of “vape” establishments. Since Dr. D does not partake in the smoking of cigarettes or the next generation of smoking, a.k.a. “vaping,” the doctor is perfectly fine with the added attention the FDA is placing on this vice. That being said, warning letters impacting medical devices appear to be at a reduced volume, so this will be the second consecutive week the doctor focusing on an observation extracted from a warning letter Dr. D visited in the last episode of Devine Guidance (DG). Yes, the doctor occasionally finds some establishments failing to comply with the eMDR requirement. Typically, these are smaller device establishments that manufacture low-risk devices that have never resulted in an adverse event. However, the agency does not grant special dispensation (look-it-up #2) when it comes to compliance. Although, they may be more forgiving, an MDR must be filed for an adverse event.
Warning Letter Excerpt
Observation Eleven (11) – “Failure to develop, maintain and implement MDR procedures as required by 21 CFR 803.17.
For example: during the inspection of your firm, firm management acknowledged that your firm did not develop an MDR procedure and the firm was unaware of the FDA regulations.
We reviewed (name redacted) response dated April 13, 2017 and find it inadequate. Your firm developed and submitted a copy of its MDR procedure titled: “Medical Device Reporting (FDA)”, SOP-QC-08, Revision A, dated March 17, 2017. After reviewing your firm’s MDR procedure, the following issues were noted: SOP-QC-08, Revision A does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the following are not addressed:
a. The procedure does not include a reference for the submission of MDR reportable events using the mandatory 3500A or electronic equivalent.
b. Although the procedure includes references to 5 day reports, it does not specify work days, respectively.
c. How your firm will submit all information reasonably known to it for each event. Specifically, which sections of the 3500A will need to be completed to include all information found in your firm’s possession and any information that becomes available as a result of a reasonable follow up within its firm.
Your firm should also adjust its MDR procedure accordingly to include a process for submitting MDRs electronically in accordance with the Final Rule for electronic Medical Device Reporting (eMDR) published in the Federal Register on February 14, 2014. In addition, your firm should establish an eMDR account in order to submit MDRs electronically.
Information about the Final Rule for eMDR and the eMDR set-up process can be found on the FDA website.
21 CFR, Part 803 – Medical Device Reporting
Section 803.17 “What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?
If you are a user facility, importer, or manufacturer, you must develop, maintain, and implement written MDR procedures for the following:
(a) Internal systems that provide for:
(1) Timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements;
(2) A standardized review process or procedure for determining when an event meets the criteria for reporting under this part; and
(3) Timely transmission of complete medical device reports to manufacturers or to us, or to both if required.
(b) Documentation and recordkeeping requirements for:
(1) Information that was evaluated to determine if an event was reportable;
(2) All medical device reports and information submitted to manufacturers and/or us;
(3) Any information that was evaluated for the purpose of preparing the submission of annual reports; and
(4) Systems that ensure access to information that facilitates timely follow-up and inspection by us.”
Compliance for Dummies
Simply stated, if medical devices are hurting people (healthcare practitioners or patients), the FDA wants to hear about it. The tool of choice and the tool mandated by law in the United States is the medical device report (MDR). If you work in this industry, eventually you or your establishment will have the opportunity to file an MDR, or should the doctor say, eMDR. Consider the opportunity a rite of passage. However, make sure your establishment is ready.
Dr. D’s broken record time: You are required to have a procedure for addressing eMDRs. If you are a manufacturer, you are required to file MDRs electronically, through the use of the ESG. These requirements are not optional. Additionally, if a medical device has resulted in or contributed to a serious injury or death, an MDR is required to be submitted to FDA. Furthermore, if a device has malfunctioned and the malfunction has resulted in a serious injury or death, an MDR is required to be filed with the FDA. However, if a patient takes an endoscope and beats the crap (no pun intended) out of the attending physician (although the injuries may be related to a now badly damaged scope) an MDR is not required to be filed with FDA, but the local authorities should be notified and the patient heavily sedated until help arrives.
Please keep in mind that MDRs that are required to be filed should be filed quickly. In any event, the regulation allows for 30 days (calendar days)—not 60 days, not 31 days, not 365 days, but 30 days. However, if there is imminent danger to the health of the general public, this reporting time is reduced to five days.
When adverse events occur (reportable or not), the FDA expects manufacturers to perform a thorough investigation. The investigation needs to be documented. Why? Because if an event or activity is not documented, in the eyes of the FDA it never happened. If a device is not returned, it is strongly recommended that the complaint files and the device history record (DHR) be thoroughly reviewed to ensure there are no obvious issues or trends associated with the suspect device or lot of devices.
Device establishments are required to collect as much information pertaining to the adverse event as possible. Part 803 clearly delineates all of the information required to be collected. If the information required by Part 803 is not readily available, have customer service, a sales rep, the complaints group, or someone intelligent enough to collect information, reach out to the healthcare provider and obtain the necessary information.
Finally, when in doubt it is better to file than not to file an MDR. There is no harm or admittance of fault associated with an MDR. An MDR is nothing more than a statement of fact that something bad happened and we will attempt to determine the underlying cause. However, if a device is racking up some ridiculously large numbers of MDRs, you can probably expect a visit from FDA.
For this week’s DG, the doctor will leave the readers with three takeaways. One: Establishing a WebTrader account to gain ESG access is a serious pain in the behind. If you do not have an account, Dr. D strongly suggests that you start the process now and be patient. Two: Device establishments are required to have a written procedure to define their MDR process. This is not optional. Please steal freely from the FDA’s regulation. Can you say copy and paste? Three: When serious adverse events occur (resulting in patient injury or death) device establishments are required to file an eMDR within 30 calendar days. In closing, thank you again for joining Dr. D, and the doctor hopes you found value (and some humor) 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 2017). 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.
- 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. (July 2017). Inspections, Compliance, Enforcement, and Criminal Investigations. Whitehall/Div of Acorn Engineering Co. Accessed August 21, 2017. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm567734.htm