For this week’s guidance, Dr. D will revisit the warning awarded an Arizona-based establishment in December of 2014. For those of you that had a chance to read the doctor’s rants from last week, the offending establishment received a warning letter from FDA that referenced no less than 10 Form 483 observations. As Dr. D mentioned last week, this establishment’s Chief Jailable Officer (CJO) and the quality/regulatory staff were clearly asleep at the proverbial wheel or woefully under-trained for this establishment to rack up so many observations and the subsequent receipt of a prized agency warning letter. It is Dr. D’s humble opinion, many of the observations noted could be categorized as basic Quality 101 requirements; therefore, no possible excuses for this type of systemic lapse in the Quality Management System (QMS) is acceptable.
One additional observation the doctor noted was for “Servicing” (Part 820.200); or should Dr. D say; “lack of an established approach.” Since this requirement is one of the less frequently cited Form 483 observations, the doctor is going to take the time and dive into this requirement for this week’s guidance. Because this establishment’s overall failure to comply with the FDA’s Quality System Regulation (QSR) can be categorized as “brobdingnagian” (look-it-up) proportions, Dr. D believes their returning to the good graces of the agency will be a significant challenge. The doctor hopes, they have the time, patience, and fiscal well-being, to be successful in their quest to achieve compliance with the QSR.
Warning Letter – 17 December 2014
Make no mistake, 10 Form 483 observations documented within a warning letter with many of the observations followed by the notation “your firm’s October 16, 2014 response is not adequate;” is not going to win any brownie points with FDA. In fact, it is probable going to ensure the agency takes a long-hard look at how this establishment corrects these deficiencies. For those of you that are not terribly familiar with the regulatory pain associated with a warning letter, correcting the deficiencies is only the tip of the proverbial iceberg. When an offending establishment is awarded the prized FDA Warning Letter, all bets are off in regards to receiving clearance and/or approvals for new products and the signing of Certificates for Foreign Governments needed to export products to markets outside of the United States. Simply stated, the FDA believes that offending establishments, on the receiving end of a warning letter, should refocus their priorities on remediating the quality issues versus worrying about filling the new product pipeline or driving sales for products introduced into commerce outside of the United States.
Warning letter excerpt
Observation Nine (9) – “Failure to establish procedures or instructions for performing servicing activities, as required by 21 CFR 820.200(a). For example, when asked by the investigator, you replied that your firm has not established procedures for performing servicing activities. During the course of the inspection, you provided Equipment Maintenance Procedure, Revision Level 001 to our investigator. Your firm provided this same procedure in your October 16, 2014 response. These procedures are not adequate, in that they do not appear to ensure the requirements of 21 CFR 820.200 are met.”
Subpart N – Servicing
Section 820.200 Servicing
“(a) Where servicing is a specified requirement, each manufacturer shall establish and maintain instructions and procedures for performing and verifying that the servicing meets the specified requirements.
(b) Each manufacturer shall analyze service reports with appropriate statistical methodology in accordance with 820.100.
(c) Each manufacturer who receives a service report that represents an event which must be reported to FDA under part 803 of this chapter shall automatically consider the report a complaint and shall process it in accordance with the requirements of 820.198.
(d) Service reports shall be documented and shall include:
- The name of the device serviced;
- Any device identification(s) and control number(s) used;
- The date of service;
- The individual(s) servicing the device;
- The service performed; and (6) The test and inspection data.”
Compliance for dummies
Obviously, if a device establishment is manufacturing single-use disposable medical devices such as urological drainage catheters or electrophysiological (EP) ablation catheters, these products do not typically have related servicing requirements. However, if the establishment is also selling the radio frequency generator needed to support the EP ablation catheter then Part 820.200 becomes a salient requirement for the establishment. The QSR is very clear about the requirements that device establishments are mandated to comply with and breaks down the requirements into four segments.
- Establishing procedures. The FDA requires device establishments that essentially introduce equipment that can be categorized as a medical device, into commerce in the United States, to establish procedures associated with their approach to servicing, Additionally, individual instructions specific to the device requiring servicing; including relevant operations performed as part of the servicing process must be scripted.
- Service report analysis. The FDA requires that service calls and the resultant service activities be documented (in writing) in a report. However, it is not sufficient to just collect the reports as documented evidence of compliance. The agency expects that an appropriate statistical methodology be employed in support of analyzing service trends. In fact, if the subsequent statistical analysis clearly identifies a performance issue, the FDA actually expects device establishments to pursue an appropriate level of corrective action in support of problem remediation. Who knew? Seriously, if a problem is repetitive, e.g., a warning light keeps burning out; the device establishment shall fix the problem. Simply stated by FDA, if the determination is that an event is reportable as an MDR, then the device establishment better make darn sure a complaint investigation is opened? Why? Because, the FDA will award such a compliance failure with a Form483 observation during one of their friendly visits for a cup of coffee and an inspection.
- Complaint and MDR reporting. When a call for service and the subsequent service report is received, as part of the review process, the device establishment shall ascertain if the service performed or requested is routine and qualifies as a service call versus an actual complaint (reference §820.198) or an adverse event that is reportable to FDA in accordance with 21 CFR, Part 803 (Medical Device Reporting) requirements. For example (as a minimum), the agency expects the following pieces of information to be collected and documented in the service report:
- (a) the name of the device serviced (recommend also collecting the model number);
- (b) the actual serial number of the device being serviced;
- (c) the date the service was performed;
- (d) the name of the individual(s) performing the service (ensure training records are available for service personnel);
- (e) specific details associated with the service performed (granularity is a good thing here); and
- (f) objective evidence that the servicing was successful and the device was returned to service in good-working order (simply stated inspection and test data is needed to support objective evidence of compliance).
- Service report content. Finally, the FDA is extremely particular in regards to what information is required to be captured in a service report. As a minimum, the following information needs to be captured in each service report:
- The model name, number, and if applicable serial number of the unit serviced;
- The actually date the service activities were performed;
- The name of the technician(s) performing the service (make sure these folks have training records);
- A detailed description of the actual service performed; and
- Documented evidence of the service such as associated test and inspection data collected as part of the service.
For this week’s guidance, Dr. D will leave the readers with just one takeaway. If your establishment is entering equipment into commerce that is deemed a finished medical device and product servicing is expected during the normal product life-cycle, then compliance with §820.200 is mandated by the QSR. Mandatory means “not optional” in the eyes of the regulatory gods at FDA. Failure to comply will result in a Form 483 observation being awarded during one of the agency’s friendly visit for a cup of coffee and an inspection.
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. (2014, April) 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’s enforcement page. (2014, December). FDA.gov Website. Retrieved January 31, 2015, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm429201.htm.
Hello Dr. Devine,
A question for dummies.
Does every returned device (RMA) for evaluation, and repair, require a formal complaint be initiated?