What the agency’s quality systems regulations regarding complaint-handling really mean

 By William A. Hyman, ScD

The issue of regulation of medical device service organizations is one of long, if intermittent, concern. It has seen renewed interest recently in the form of the U.S. FDA’s December 2016 workshop on the subject, which followed a March 2016 request for comments that generated 179 responses.

The FDA’s presentation at this workshop noted that the agency had first issued a compliance policy guide on the subject in 1987. In 1983, the FDA began work on the quality systems regulations (QSR), which initially included servicers and refurbishers.

In 1996, the FDA said that in its view, servicers and refurbishers were “manufacturers,” but these entities would be covered in later rulemaking. Calling them manufacturers brings them into the FDA fold even though they are substantially different entities. Thus is the power of definitions.

In 1997, the FDA issued a notice of rulemaking with respect to refurbishers, reconditioners, servicers, and remarketers of medical devices, but no rule was forthcoming after this notice. In 1998, an AAMI/FDA taskforce further studied the problem, concluding that “voluntary controls” would suffice. I do not know if such voluntary controls were ever developed and recognized. In 1998, the 1987 Policy Guide was rescinded. And this is where we now stand.

Recently, a bill was introduced in Congress that addresses a small piece of this arena by directing a change in the FDA regulation of manufacturer complaint-handling. What’s more, it adds that servicers must “establish a complaint handling system equivalent to a system meeting the requirements of section 820.198 of title 21, Code of Federal Regulations (or successor regulations).”

This section is part of 21CFR820, which more broadly is the current QSR. The QSR regulations and complaint handling now apply only to “manufacturers of finished medical devices.” A different section of the QSR, 820.200, addresses servicing by medical device manufacturers.

In the current discussion, there continues to be some confusion about who newly added servicers would encompass. Servicers, in general, include the manufacturer, a hospital-employee in-house department, or a “third party,” which may or may not be present in the hospital.

Third parties might address a wide or narrow range of medical devices from one or more manufacturers. Of course, there is also an ongoing debate about whether service needs any federal intervention to help assure patient safety, and whether some opinions on the subject are self-serving.

Putting aside the broader questions regarding the need for greater service regulation, in this article I will look specifically at 820.198—which, as it is currently written, applies to manufacturers. My goal is to see what it might mean, in its current form, for the to-be- added non-manufacturer service providers. I will also look at 820.200.

The following tables present the current elements of 820.198 and 820.200 with my commentary on how they might apply to servicers. In each section, the word “manufacturer” would be modified to include these non-manufacturer service providers, unless the word itself is redefined to include them.

820.198 – Complaint Handling

Complaint-handling regulation language: (a) Each manufacturer* shall maintain complaint files. Each manufacturer shall establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. Such procedures shall ensure that: all complaints are processed in a uniform and timely manner and oral complaints are documented upon receipt.

Author comments: If a servicer receives complaints, presumably about the service they provided, then it makes sense to have a formal way to process, track, file and— most importantly—resolve these complaints. This appears to be good business practice and a means to improve service quality.

Improving service quality might also serve to protect device users and patients from the consequences of service-related failures. The extent of such failures is part of the discussion of the need for FDA intervention.

Complaint-handling regulation language:  (b) Each manufacturer shall review and evaluate all complaints to determine whether an investigation is necessary. When no investigation is made, the manufacturer shall maintain a record that includes the reason no investigation was made and the name of the individual responsible for the decision not to investigate.

Author comments: This is the logical function of complaint-handling. It is not appropriate to receive and file complaints yet not determine if they need to be investigated further. This determination can be critical, and it therefore makes sense to record how that decision was reached and by whom. This appears to be good business practice.

Complaint-handling regulation language: (c) Any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications shall be reviewed, evaluated, and investigated, unless such investigation has already been performed for a similar complaint and another investigation is not necessary.

Author  comments: This would have to be rewritten to apply to servicers. Perhaps “any failure related to the servicing of a device shall be reviewed, evaluated, and investigated, unless such investigation has already been performed for a similar complaint and another investigation is not necessary.” The last phrase is odd unless it assumes that the cause of the repeated complaint has already been resolved or is currently under study.

Complaint-handling regulation language: (d) Any complaint that represents an event which must be reported to FDA under part 803 or 804 of this chapter shall be promptly reviewed, evaluated, and investigated by a designated individual(s) and shall be maintained in a separate portion of the complaint files or otherwise clearly identified. In addition to the information required by 820.198(e), records of investigation under this paragraph shall include a determination of:

  • Whether the device failed to meet specifications
  • Whether the device was being used for treatment or diagnosis
  • The relationship, if any, of the device to the reported incident or adverse event

Author comments: Non-manufacturer and non-hospital servicers are not currently required to report device events to the FDA. Thus, the Medical Device Reporting (MDR) reporting regulation would have to be revised if reporting by servicers is to be mandatory. Voluntary reporting is currently available.

Note that a hospital-run department is in effect required to report, or more exactly the hospital is so required, under 21CFR803 Medical Device Reporting, but only when there is a death or serious injury. Manufacturers must also report certain malfunctions. Part 804 applies to distributors. There is a curiosity here in that a hospital-administered department is clearly covered by MDR, but a resident contractor might not be. In the latter case, the hospital might be the required reporter.

Complaint-handling regulation language: (e) When an investigation is made under this section, a record of the investigation shall be maintained by the formally designated unit identified in paragraph (a) of this section. The record of investigation shall include:

  1. The name of the device
  2. The date the complaint was received
  3. Any device identification(s) and control number(s) used
  4. The name, address, and phone number of the complainant
  5. The nature and details of the complaint
  6. The dates and results of the investigation
  7. Any corrective action taken
  8. Any reply to the complainant

(f) When the manufacturer’s formally designated complaint unit is located at a site separate from the manufacturing establishment, the investigated complaint(s) and the record(s) of investigation shall be reasonably accessible to the manufacturing establishment.

Author comments: This section makes sense for a servicer. If complaints are going to be received and processed, and a complaint then results in an investigation, the results of that investigation should be documented. This is simply sound business practice. Section (7) might be the key outcome since it asks what has been done to mitigate the service-related failure.

This is an administrative detail that would be applicable. After all, it doesn’t make sense for complaint files to be in a location the servicer can’t access.

Complaint-handling regulation language: g) If a manufacturer’s formally designated complaint unit is located outside of the United States, records required by this section shall be reasonably accessible in the U.S. at either a location in the U.S. where the manufacturer’s records are regularly kept or the location of the initial distributor.

Author comments: This is the same issue as (f) above.

Note: “manufacturer” has been italicized to emphasize that this would be amended to include servicers.


Complaint-handling regulation language: (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.

Author comments: The current discussion is all about servicing, and for routine service having known methods seems appropriate. This area does cross over into alternative equipment management issues.

Complaint-handling regulation language: ((b) Each manufacturer shall analyze service reports with appropriate statistical methodology in accordance with 820.100.

Author comments: It is good practice to track and review service records to see if there are repetitive or unresolved issues. 820.100 outlines requirements for manufacturers to undertake corrective and preventive actions, which is yet another subject that might have parallels in service.

Complaint-handling regulation language: (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.

Author comments: Reportable events were addressed above under complaint handling.

Complaint-handling regulation language: (d) Service reports shall be documented and shall include:

  • The name of the device serviced
  • Any unique device identifier or universal product code, and any other device identification(s) and control number(s) used
  • The date of service
  • The individual(s) servicing the device
  • The service performed
  • The test and inspection data

Author comments: This again seems like good business practice: knowing what was serviced, by whom, and what was found.

Whether by FDA action, legislation, or both, the subject of the regulation of service providers is currently popular. What actions the FDA may take, if any, and what legislation might be passed, if any, are subjects that deserve a watchful eye—and ongoing input from the biomed community.


  1. https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm511411.htm#registration
  2. https://www.congress.gov/bill/115th-congress/house-bill/2118/text
  3. 3. 21CFR 820.1, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr

William A Hyman, ScD, is professor emeritus, biomedical engineering, at Texas A&M University in College Station, and adjunct professor of biomedical engineering at The Cooper Union, New York.