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Complaint Handling and Medical Device Reporting - fda

Complaint Handling and Medical Device Reporting - fda 2025

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The document provides an overview of complaint handling and medical device reporting (MDR) regulations as outlined by the FDA. It details the requirements for manufacturers regarding complaint files, including the need to maintain records, evaluate complaints for reportability, and conduct investigations when necessary. The document also explains the mandatory reporting obligations under 21 CFR 803, defining reportable events and timelines for submission of reports. Additionally, it discusses exemptions from reporting requirements and resources available for industry education and assistance.

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What FDA regulation is required for medical device compliance?

Quality System Regulation (QS regulation) - 21 CFR Part 820 The quality system regulation includes requirements related to the methods used in and the facilities and controls used for: designing, purchasing, manufacturing, packaging, labeling, storing, installing and servicing of medical devices.

How do I complain to the FDA about a medical device?

Call: (301) 796-6670. Email: MDRTHelpdesk@fda.hhs.gov.

What are the 803 reporting requirements?

Medical Device Manufacturer Reporting Requirements Under 21 CFR Part 803, medical device manufacturers must submit a report within 30 days of becoming aware of information from any source which suggesting a marketed device may have caused a death or serious injury.

What is the MDR regulation?

The medical device regulation (MDR) or European Union medical device regulation (EU MDR) is a new set of regulations that govern the clinical investigation, production and distribution of medical devices in Europe.

What is the mandatory medical device reporting?

Mandatory Medical Device Reporting: The Medical Device Reporting (MDR) regulation (21 CFR Part 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA.

What is 21 CFR Part 820 for medical devices?

21 CFR Part 820 is a set of regulations from FDA that outlines the current good manufacturing practice (CGMP) requirements that medical device manufacturers in the United States must follow with regards to their quality system.

What is complaint handling in medical device?

The medical device complaint handling process is a systematic approach employed by companies to efficiently manage and resolve complaints. This process encompasses receiving, reviewing, evaluating, investigating, and addressing customer complaints in a timely and effective manner.

Complaint Handling and Medical Device Reporting - fda 2025

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