Devine Guidance

What Part of Death or Serious Injury is Not Being Understood?

By Dr. Christopher Joseph Devine
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Being delinquent in your establishment’s medical device reporting responsibilities is going to elevate FDA’s concern and bring an appropriate response for offending device manufacturers, including a warning letter. This week’s guidance reviews the sins of an offending establishment and discusses some of the salient requirements associated with complying with 21 CFR, Part 803.

Folks, Dr. D was going to write about contract manufacturing this week but after reading a particularly disturbing warning letter, the doctor decided to change course and write about adverse event reporting in the United States and the need to comply with 21 CFR, Part 803 – Medical Device Reporting. 

For those of you not terribly familiar with the requirement, 21 CFR, Part 820.198 (a) (3) under “Complaint Files” points directly to 21 CFR, Part 803 and the need to review complaints and determine if adverse events are reportable to FDA using the MDR (paper or eMDR). The doctor also recommends a weekly visit to the FDA’s MAUDE database to see what the agency is citing as compliance issues with your industry brethren. Folks, the “redoubtable” Dr. D would never lead my readers astray; however, being delinquent in your establishment’s medical device reporting responsibilities is going to elevate FDA’s concern and bring an appropriate response for offending device manufacturers, including a warning letter. For this week’s guidance, the doctor will review the sins of an offending establishment and discuss some of the salient requirements associated with complying with 21 CFR, Part 803. Enjoy. 

 

FDA Warning Letter – Dated 03 February 2014

1. Failure to report to 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 a device that your firm markets may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(2). The following examples demonstrate reportable events that were not submitted as MDRs within the required time frame. These examples are not all-inclusive and there may be additional reportable events that your firm failed to report. 

For example: Complaints (b)(4) describe a malfunction of the HeartSine Samaritan 300P and Pad Pak that is directly related to an open recall. As such, the complaints meet the criteria for reportability. We reviewed your firm’s response, dated (b)(4), and conclude that it appears to be adequate. Your firm cited the root cause for late reporting of MDRs as related to (b)(4). Your firm opened a (b)(4) to address corrections, which include (b)(4) cited in the FDA 483 (Observation 5); as well as other corrective actions.

2. 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 (b)(4), the following issues were noted: 

i. Procedure (b)(4) 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. The procedure omits the definitions for the terms “caused or contributed” 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). 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).

ii. Procedure (b)(4) 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 the correct address for where to submit MDR reports: FDA, CDRH, Medical Device Reporting, P. O. Box 3002, Rockville, MD 20847-3002.  

iii. Procedure (b)(4) does not describe how it will address documentation and record-keeping requirements, including: 

a. Documentation of adverse event related information maintained as MDR event files.  

b. Information that was evaluated to determine if an event was reportable. 

c. Documentation of the deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable. 

d. Systems that ensure access to information that facilitates timely follow-up and inspection by FDA. 

Your firm’s procedure includes references to (b)(4). Annual certifications are no longer required and we recommend that all references to an (b)(4) be removed from your firm’s MDR procedure (see: Fourth Notice, Federal Register, dated March 20, 1997: Medical Device Reporting; Annual Certification; Final rule).

Warning Letter Sins

I know this will sound like one of Dr. D’s broken record speeches from the pulpit, but what part of not having a compliant procedure is not being understood? When FDA employs phrases such as “does not establish” of “failure to establish” in a warning letter, you can take it to the bank the agency was not pleased with an establishment’s procedure(s) and/or level of compliance. The recipient of the warning letter referenced in this week’s Devine Guidance further alienated the agency by depicting the incorrect address and the annual reporting requirement that was removed long before the white hairs started appearing on the doctor’s head. Really folks? The annual requirement, for manufacturers, was removed years ago. 

Additionally, Dr. D strongly recommends reviewing all procedures at least annually to ensure they are still relevant and in compliance with statutory and regulatory requirements. For those of you that are regulatory connoisseurs, §803.17 specifically requires the developing, maintaining, and implementing of written procedures. As for failing to report an MDR within 30-days, there must have been a serious disconnect with this establishment. Although the warning letter does not give an exact amount, the inference within the warning letter is multiple violations occurred. One or two late MDRs could be premised on an oversight (no excuses mind you); however, multiple late MDRs is reflective of a systemic breakdown. 

 

Salient requirements associated with 21 CFR, Part 803 (Manufacturer) 

Furthermore, Dr. D strongly suggests that medical device establishments ensure these salient requirements are addressed by a written (established) procedure. Please note: this is not an all-inclusive list but a brief summary of the major points depicted in §803: 

  • For starters, establishments are required to script a cohesive procedure. Dr. D strongly suggest that you read §803.17.  
  • Ensure individual adverse event reports are filed within 30-days, after the day your establishment becomes aware of reportable death, serious injury, or malfunction.  
  • Ensure individual adverse reports are filed within five days, after the day your establishment becomes aware of: 
    • (a) a reportable event that reflects an unreasonable risk of substantial harm to the public; or 
    • (b) a reportable event where the FDA makes a written request. 
  • Do not forget about the need to incorporate the supplement reports and their requirements.  
  • Written reports must be sent to FDA. The current address is FDA, CDRH, Medical Device Reporting; P.O. Box 3002, Rockville, MD 20847-3002. Make sure each report is appropriately titled, e.g. “Manufacturer Report.”  
  • For establishments located outside of the United States, the FDA requires reports to be made in English; however, that may change in another 20 years (just kidding).  
  • If an establishment is a large producer of MDRs, electronic submissions are the answer. Contact FDA for more information.  
  • Keep meticulous records. Why? Records are a Chief Jailable Officer’s (CJO) best friend needed to support claims of compliance during a friendly FDA inspection. Simply stated, if there are no documented records, an event simply did not occur in the eyes of FDA. 

Takeaways 

For this week’s guidance, the doctor will leave the readers with three takeaways. One – always file MDRs on time. If you are unsure about the need to file and MDR for an adverse event, it is better to error on the side of caution and just file baby. Two – ensure a procedure that governs your organization’s MDR process is developed, implemented, and maintained. Third – always keep meticulous records as the CJO will need these to support claims of compliance during a friendly FDA visit. 

In closing, thank you 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. 

References:

  1. Code of Federal Regulation. (2013, April). Title 21 Part 803: Medical device reporting. Washington, D.C.: U. S. Government Printing Office. 
  2. Code of Federal Regulation. (2013, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U. S. Government Printing Office. 
  3. Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon. 
  4. Warning Letters – Inspections, Compliance, Enforcement, and Criminal Investigations. (2014, February). Retrieved February 18, 2014, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm385301.htm.

About The Author

Dr. Christopher Joseph Devine, President, Devine Guidance International

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