Medical Device Quality Systems Manual
A Small Entity Compliance Guide First Edition (Supersedes the
Medical Device Good Manufacturing Practices [GMP] Manual):
Complaints
INTRODUCTION
Section 820.3(b) of the Quality Systems regulation defines a complaint as "any written,
electronic, or oral communication that alleges deficiencies related to the identity, quality, durability,
reliability, safety, effectiveness, or performance of a device after it is released for distribution." All
medical device manufacturers are subject to the complaint requirements in 21 CFR Part 820,
Quality System regulation and to the reporting requirements in 21 CFR Part 803, Medical Device
Reporting (MDR) regulation. A complaint is any indication of the failure of a device to meet
customer or user expectations for quality or to meet performance specifications. A complaint may
be lodged against any finished device that had been released for distribution. Any complaint
involving the possible failure of a device, labeling, or packaging to meet any of its specifications is
subject to the provisions of 21 CFR 820.198, Complaint Files.
The sources of oral and written complaints are numerous. A manufacturer can receive this
information via telephone, facsimile, written correspondence, sales representatives, service
representatives, scientific articles, and FDA or internal analyses. Information will also be submitted
by health care professionals, lay users, consumers, user facilities and distributors on the MedWatch
Forms FDA 3500 and FDA 3500A.
Manufacturers are required to review, evaluate, and, when appropriate, investigate complaints,
establish and maintain written procedures describing the process used to perform these activities,
and designate a responsible individual or entity to perform these tasks. Complaints concerning death,
serious injury or malfunctions, as defined in the MDR regulation, shall be reported to FDA as
discussed later. Manufacturers of any class of medical devices are never exempted from the Quality
System regulation complaint requirements (820.198) nor the general record requirements (820.180)
which permit FDA review and copying of these records. Complaint file requirements are necessary
to make certain manufacturers have adequate quality systems for investigating complaints and taking corrective action. Access to complaint files, device-related death and injury reports, and
complaints about device defects enables FDA to determine if a manufacturer's quality system and
corrective actions are adequate.
Manufacturers can identify problems with device component, labeling and packaging quality by several methods. To meet all GMP requirements these identification methods should include a review and evaluation of all complaints, failed devices, and service or repair requests. Complaints
and service or repair requests are important sources of feedback information for a quality system.
Finished devices that are returned for service or repair may meet the complaint requirements
identified in section 820.198; therefore, these service or repair requests shall be evaluated to
determine if they are complaints. Service or repair data shall be reviewed [820.200(b)&(e)] to
identify systematic problems and problems that may qualify as complaints. When these problems
are identified they should be processed as complaints according to the requirements in 820.198.
Complaint data, in conjunction with product audits, QA systems audits, operational analyses,
inspection and test data, etc., is used by the quality assurance organization to: z identify poor performance in the overall quality system, particularly faulty design of
devices, and faulty manufacturing processes; z aid in implementing solutions to these quality problems;
z verify confidence in, and improve the performance of the quality system;
z improve the safety and performance of devices;
z reduce medical device reporting;
z reduce costs and improve production schedules;
z reduce employee confusion;
z improve customer relations by reducing the frequency of problems, complaints, and
recalls;
and, z assure compliance with device regulations and consensus standards.
Complaint Handling System
An effective complaint handling system is an extremely important part of any quality system.
Even manufacturers who have not received complaints should be prepared to receive and process
them. Manufacturers should understand that any complaint received on a product shall be evaluated
and, if necessary, thoroughly investigated and analyzed, and corrective actions shall be taken. The
