21 CFR 801 & 21 CFR 803 Explained: Labelling and Adverse Event Reporting Requirements

Summary?

• 21 CFR 801 provides a detailed explanation of labelling requirements for medical devices.?

• Labelling requirements play a vital role in ensuring the safety and proper use of medical devices.?

• 21 CFR 803 provides a detailed explanation of medical device reporting and methods to report adverse events (AEs).?

• Medical device reporting plays a crucial role in monitoring the safety of medical devices.?

Short Description?

Labelling and AE reporting requirements for medical devices are mentioned in the Code of Federal Regulations (CFR) under Part 801 and Part 803, respectively. Both regulations have distinct requirements for medical devices but serve to ensure their performance and the safety of the user.?

Labelling Requirements as per 21 CFR 801?

Labelling requirements for medical devices are mentioned in CFR Part 801. This part is divided into various subparts to elaborate on the different aspects that are required for labelling a medical device.

Subpart A: Labelling Requirements for Unique Device Identification?

The format of the unique device identifier is:1?

• Unique Device Identifier (UDI): Every medical device must bear a UDI, with exceptions in certain cases.?

• Technical Requirements of UDI: UDI must be presented in easily readable plain text as well as in automatic identification and data capture technology form. It must also include a device identifier segment.?

• Permanent UDI Marking: If the medical device is to be reused or reprocessed, it must contain a permanent UDI marking.?

• Stand-alone software: Stand-alone software regulated as a medical device must contain UDI as an easily readable plain text when the software is started and through a menu command.?

Subpart B: Labelling Requirements for Over-the-Counter Devices?

Labelling requirements for devices that do not need a prescription are given in Figure 1.1?

Figure 1: Labelling Requirements for Over-the-Counter Devices?

Subpart C: Exemptions From Adequate Directions for Use?

The following devices are exempted from labelling adequate directions for use:1??

• Prescription Devices: Devices that can be used only under the supervision of a licensed practitioner are exempt from labelling adequate directions for use. Retail exemptions may apply if the device is delivered by a licensed practitioner or with their prescription.?

• Devices with Known Directions: Exemptions apply if the directions for use are already known to a layperson.?

• Other Devices: Devices such as in vitro diagnostic products, those intended for processing, repacking, manufacturing, teaching, law enforcement, research, and analysis are also exempted.?

Subpart D: Other Exemptions?

The device delivered, per the trade practices, and processed, labelled, or repacked at another establishment will be exempted from labelling during the following:1?

• Introduction into state?

• Time of interstate movement?

• Holding at an establishment?

Subpart E: Special Requirement for Specific Devices?

Devices with special requirements include:1?

• Denture Relines and Repairing Kits: Warnings such as “for emergency repairs only” or “for temporary use only” must be accompanied by clear instructions that a layperson can understand.?

• Menstrual Tampons, Latex Condoms: Labelling menstrual tampons and latex condoms with clear information, including warning signs, risks, and guidance on when to seek medical attention, should be legible and clearly explained.?

• Other Specific Devices: Devices with impact-resistant lenses, prescription hearing aids, devices of natural rubber, and those using ozone and chlorofluorocarbons must have labels with clear warnings and safety instructions.?

Medical Device Reporting as per 21 CFR 803?

The requirements for medical device reporting are mentioned in CFR Part 803. This part is divided into various subparts to elaborate on reporting methods for manufacturers, importers and user facilities. The key aspects of 21 CFR 803 are mentioned below:2?

• Reporting AEs: Manufacturers, importers and user facilities must report AEs or any device-related problems to the Food and Drug Administration (FDA). This includes AEs or any device-related problems that may have contributed to or caused serious injuries or death.??

• Reporting Timeframe:?

• User Facilities: Must submit reports of death or serious injuries as soon as practicable but no later than 10 workdays to both the manufacturers and FDA. Serious injuries are to be reported within 10 days to the manufacturer; however, can be reported to the FDA if the manufacturer is unknown.?

• Importers: Must submit the reports of deaths and serious injuries to the FDA and malfunctions to the manufacturer within 30 working days.?

• Manufacturers: Must submit reports of serious injuries, death or malfunctions to the FDA within 30 calendar days.?

Conclusion?

21 CFR 801 provides a detailed explanation of labelling requirements for medical devices, which are essential for safety and to provide proper information regarding the device to its users. 21 CFR 803 explains the reporting of AEs and device-related issues so that monitoring of the safety and performance of the device is done to prevent any potential harm to the user. Both 21 CFR 801 and 803 ensure device safety compliance.?