Medical Device Reporting (MDR): Compliance Guide to 21 CFR Part 803
21 CFR Part 803 is a regulation under the United States Food and Drug Administration (FDA) that outlines the Medical Device Reporting (MDR) requirements. This regulation is designed to help ensure the safety and effectiveness of medical devices by requiring manufacturers, importers, and user facilities to report certain device-related adverse events and product problems to the FDA.
What is 21 CFR Part 803?
21 CFR Part 803 specifies the mandatory reporting of adverse events and device malfunctions by manufacturers, importers, and user facilities. The regulation aims to facilitate early detection of potential safety issues related to medical devices, thereby protecting public health. It requires timely and accurate reporting to ensure the FDA has the information needed to take appropriate action when necessary.
Who needs to be compliant with 21 CFR Part 803?
Compliance with 21 CFR Part 803 is required for:
Manufacturers: Entities that produce and distribute medical devices intended for human use.
Importers: Companies that import medical devices into the United States for commercial distribution.
User Facilities: Health care facilities such as hospitals, outpatient diagnostic or treatment facilities, and nursing homes.
These parties must adhere to the reporting requirements to help monitor device performance and ensure patient safety.
What are the different parts of 21 CFR Part 803 and their requirements?
21 CFR Part 803 is structured into several subparts, each detailing specific requirements for medical device reporting. Here is an overview of each section:
Subpart A: General Provisions
Subpart A describes in general the scope and definitions used in this section of the legislation. It describes the form that needs to be used, the deadlines for reporting and how submissions are followed up.
The general requirements for user facilities (further detailed in Subpart C) are:
Individual adverse events need to be reported no later than 10 days after becoming aware of the reportable event
reports of device related deaths need to be reported to the FDA and the manufacturer (if known)
reports of device related serious injuries need to be reported to the manufacturer or if the manufacturer is unknown, they need to be submitted to the FDA
Annual reports need to be submitted to FDA
For Importers, the general requirements (further detailed in Subpart D) are:
Individual adverse events need to be reported no later than 30 days after becoming aware of the reportable event
reports of device related deaths or serious injuries need to be reported to the FDA and the manufacturer
Reports of device related malfunctions need to be submitted to the manufacturer
General requirements for manufacturers (further detailed in Subpart E) are as follows:
Reports of individual adverse events need to be submitted to the FDA no later than 30 calendar days after the day of becoming aware of a reportable death, serious injury, or malfunction
In case of a written request by the FDA or an event that requires remedial action to prevent an unreasonable risk of substantial harm to the public health, the report needs to be submitted not later than 5 days after becoming aware.
Supplemental reports need to be submitted when new/more information is available as compared to the initial report.
Subpart B: Generally Applicable Requirements for Individual Adverse Event Reports
This part describes the general requirements for the reports. There are two main kinds of reports: voluntary and mandatory. The form to be used for voluntary reports is Form FDA 3500. For mandatory reporting, Form FDA 3500A is to be used.
Subparts C-E: specific requirements for manufacturers, importers and user facilities
These sections include the information that needs to be provided when reporting adverse events. In a detailed list, all the different aspects of both the adverse event reporting as well as the annual reports are listed.
Efficient reporting requires good documentation
In order to provide the correct data within the required deadlines is critical to ensure compliance. In stressful situations this can be even more challenging. Therefore it's key to maintain your product information and documentation, as well as your entire QMS in a structured way. Matrix Requirements is built to allow you to have full traceability within your design documentation and your QMS. It allows you to easily extract the required information when needed. Having your QMS, including CAPAs on the same platform as your design documentation ensures complete interlinking and easy extraction of any information you need to submit to regulatory authorities.
For companies accelerating the development of innovative medical device technologies, Matrix Requirements provides an easy-to-use, flexible, all-in-one software solution that: facilitates collaboration of employees on design control, and quality management to streamline medical device design, establish lean quality management, accelerate product certification and go-to-market, and maintain regulatory compliance, even as you're undergoing research into 21 CFR Part 803. If you'd like to explore Matrix Requirements further and how we can help you navigate 21 CFR Part 803, don't hesitate to book a demo.