One of the salient terms FDA went to great lengths to define is the word “establish”. In accordance with 21 CFR, Part 820, Section 8.3(k), “establish” means to define, document (in writing or electronically) and implement. Can you say written procedures? It always blows the doc’s mind when he reads about a device establishment’s failure to establish or fully establish a procedure. Especially when the FDA clearly states a procedure is warranted. These days, (Dr. D’s opinion) it appears FDA is handing Form 483 observations to device establishments failing to establish robust procedures in support of medical device reporting (MDR), not unlike candy to the masses on Halloween. However, no trick or treat greeting is needed. Couple a failure to establish a robust procedure for MDRs (including the electronic reporting requirement), with a failure to file MDRs in a timely fashion or not at all, and the regulatory pain unleashed by the FDA is quickly felt by an unwitting Chief Jailable Officer (CJO). Frankly, there just might be a nice little kerfuffle (look-it-up) when the investigator from the FDA hands the CJO from an offending establishment a long list of Form 483 observations. Enjoy!
Warning Letter – June 30, 2016
When you have the opportunity to review as many warning letters as old Dr. D, they all start to run together, and they end up being warning-letter mush in the old doctor’s mind. However, from time to time, some warning letter observations just seem to pop up off the FDA’s Enforcement Action page and grab Dr. D’s attention. This is especially true when a requirement such as e-MDRs has not been addressed by procedure and noted as such in an establishment’s warning letter. It is Dr. D’s humble opinion (yes, the doc has a few humble opinions – not many though), when issues with complaints (§820.198), MDRs (Part 803) and recalls (Part 806) are collectively noted during an establishment inspection, bad things are about to happen to the offending establishment. There is no need for the CJO to consult a tarot card reader, Irish tea-leaves reader, palm reader or crystal ball. All a CJO has to do is wait for the warning letter to arrive courtesy of the United Parcel Service. Can you say, “Sign here please?”
Warning Letter Excerpt
Observation Eight (8). “Failure to implement written MDR procedures, as required by 21 CFR 803.17.”
“After reviewing your firm’s MDR procedure, titled “Medical Device Reporting”, Doc No: QOP8504, Rev B, Date 3/16/12, the following deficiencies were noted.”
Please note, there were multiple comments in the warning letter so Dr. D will summarize:
- Definitions excluded from the procedure
- Failure to define a process for the timely transmission of complete medical device reports
- Failure to define the record keeping process associated with MDRs
- Failure to address the electronic MDR reporting that went live in August of 2015
21 CFR, Part 803 – Medical Device Reporting
Sec. 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 followup and inspection by us.”
Compliance for Dummies
It’s Dr. D broken record time, my dear readers, “Device establishments shall establish a robust procedure for medical device reporting, in accordance with 21 CFR, Part 803.” In fact, since device establishments pay for the pain of an inspection, courtesy of their annual fees to play in the agency’s regulatory sandbox, it is acceptable to steal freely from the published regulations (all of them). Seriously, it is okay to plagiarize the heck out of 21 CFR, Part 803. In fact, the FDA encourages it in their pursuit of driving home compliance throughout the device industry.
The alternative to compliance is non-compliance (duh) due to a failure script a procedure, script a fully compliant procedure, failure to implement a procedure, and failure to routinely comply with a procedure (e.g., establish). That being said, there are a few salient elements associated with Part 803 that all industry professionals should understand.
- If a device manufacturer becomes aware of an adverse event, associated with their device that may have resulted in serious injury or patient death, they have 30 days to notify FDA (electronically) through the use of Form 3500A. Not 60 days, not 45 days, not 31 days; the requirement is 30 days (§803.50).
- If a device manufacturer becomes aware of a reportable event associated with their device that necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health, they have five days to notify FDA. Not 30 days, not 15 days, not seven days. The requirement is five days (§803.53).
- Selecting the appropriate form to file an MDR is another non-rocket science-worthy task. In accordance with §803.11 you have two choices: (a) Form 3500A or (b) an approved electronic equivalent. Keep it simple and use the FDA’s Form. After all, your establishment’s registration fees already paid for the development of this form many, many, moons ago.
- As for the submission process, in accordance with §803.14, reports get submitted electronically. Not by FedEx, UPS, the U.S. Mail or a very strong carrier pigeon; the reports are submitted electronically. After all, this is the 21st Century.
For this week’s guidance, the doctor will leave the readers with three takeaways. One: Make sure all MDRs (30-day or 5-day responses) are always filed on time. Two: It makes no sense reinventing the proverbial wheel. Use the FDA’s Form 3500A. Three: Filing MDRs electronically (e-MDR) has been required since August 2015. Now would be a good time to climb aboard that train. In closing, thank you again for joining Dr. D, and I hope you found 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. (2015, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office.
- Code of Federal Regulation. (2015, 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.
- 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. (June 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Trimed, Inc. Accessed August 01, 2016, Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm514006.htm