Q: What is a Medical Device complaint?
A: FDA defines “complaint” as any written, electronic, or verbal communication that alleges something is wrong with the product or device after it is released for distribution. In other words, if the company receives a phone call, email, letter, a verbal report from a sales person, a social media post on facebook or yelp for example, that claim some sort of product issue then a complaint record must be documented for that event. Even if the complaints are outside of the US, they still need to be captured.
Q: What are the regulatory requirements that companies must follow for customer complaints?
A: Companies must follow the regulation stated in FDA 21 CFR 820.198 and ISO 13485:2016, section 8.2.2 for medical device manufacturers.
Q: What do companies need to have in place to manage complaints?
A: Companies should have a governing policy and procedure that defines how they receive, review, evaluate and investigate complaints for their product. There should be designated staff that are dedicated to handling complaints because FDA has strict timeline requirements to intake the complaint and then report it to FDA through the Medical Device Reporting electronic system. The company needs a tracking system to manage the complaints which is usually a software program that tracks and monitors the handling of the complaint from the beginning until it’s closed.
Q: Why is the procedure important?
A: When you are inspected by the FDA or audited by ISO registrar, how you manage complaints is always one of the subjects looked at. Failure to adequately manage complaints is a common reason for the issuance of warning letters.
Q: What is the general process for managing a complaint?
A: There are 3 key decisions that must be made during processing a customer complaint. The company intakes the complaint and documents the details based upon the customer description of the problem. The first decision for the company to make is to determine if the complaint is reportable to the FDA. If it is, then the company must follow the MDR process to notify FDA. If it is not, the 2nd decision by the company is to determine if the complaint requires further investigation within the quality, manufacturing, testing, labeling and packaging elements of the product. The company may also determine no addition information is necessary and close the complaint right away with a written justification why that is acceptable. And the 3rd decision made by the company is whether any corrective actions are warranted in the manufacturing of the product.
Q: What makes the complaint reportable to the FDA?
A: The exact details can be found in the FDA 21 CFR 803 Medical Device Reporting (MDR) regulations. But in general, a medical device manufacturer, must report any incidents where the device may have contributed to a serious injury or death, or malfunctioned in such a manner that would likely cause serious injury or death should a similar malfunction happen again.
Q: How does the medical device “contribute” to a serious injury or death?
A: An investigation may determine the device had a complete failure to function, or a malfunction in the performance of the device. This may be due to an inadequate design, labeling, instructions for use, user error, manufacture error or other reasons. User Errors may result from unclear instructions which may pose a big problem for the general public. Let’s just imagine if the instructions for use were not clear for how to use an over the counter breath analyzer, or glucose monitor, or even something simple like a knee brace. The amount of people impacted at once could be tremendous. The FDA needs to know about that.
Q: What’s the minimum information you need to capture for a complaint record?
A: At a minimum, complaint investigations must include:
- Name of the medical device
- Date complaint received
- Any device identification (e.g. part #, lot #, batch #, serial #)
- Complainant contact information
- Nature and details of complaint
- Dates and results of investigation
- Any corrective action taken
- Any reply to the complainant
As always, a clear documentation trail is key to demonstrating you have a thorough and robust complaint handling process. Failure to do so will most likely result in FDA audit observations—and even possibly even a warning letter.