Complaint form



Complaint form

Customer feedback is essential for any business, but it’s especially critical for regulated companies. In the life science industry, customer complaint forms in particular serve as an important channel for communicating problems with products and services that could affect patient safety.

The QSR applicable to medical device manufacturing defines a complaint in 21 CFR Part 820 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.”1 ISO 9001, ISO 13485, and relevant guidance documents share similar definitions.

In the United States, the rate of innovation and technological advancement greatly accelerated in the 1960s. And by the mid to late 1970s, the new Medical Device Amendments to the 1938 Federal Food, Drug, and Cosmetic Act had come into full effect. The amendments normalized a device classification system based on risk and market clearance requirements, i.e., premarket approval (PMA) and premarket notification 510(k) application requirements.

A complaint is an indication of dissatisfaction with device quality or performance, or of a defect after a product has been released for distribution. It is, therefore, an excellent postmarket surveillance indicator.

A complaint could lead to repair, servicing, and changes in a manufacturer’s recommendations. A substantial complaint-related failure can lead to recalls and even product seizure. Device failures (or potential failures) do not only refer to a device itself, but also to its labeling and packaging.

Medical device manufacturers must record and track customer complaints according to the Quality System Regulation (QSR) defined in 21 CFR Part 820. Additionally, FDA Part 803 regulations require firms that have received complaints of device malfunctions, serious injuries, or deaths to notify the FDA.

You should already be well aware that deficiencies in complaint handling and Medical Device Reporting are two of the most common reasons why the FDA issues 483 inspection observations and Warning Letter.

The Complaint form contains the followings informations:

  • Contact Information
  • Product Information
  • Description of Event
  • Complaint Determination
  • Complaint Investigation
  • Corrective Action reference
  • Corrective Action reference