Nouveauté ! Développez votre produit SxMD avec un eQMS structuré comprenant des modèles SxMD prêts à être audités et conformes aux normes EU et US. En savoir plus !
What is 21 CFR Part 812? Must know for Medical Device manufacturers.
One crucial regulation governing investigational devices in the United States is 21 CFR Part 812. Not to be confused with 21 CFR Part 820 or 21 CFR Part 11, understanding the intricacies of the 21 CFR Part 812 regulation is vital for companies and researchers involved in the development of medical devices. In this article, we delve into the essence of 21 CFR Part 812, exploring its significance, requirements, and implications.
What is an investigational device exemption?
Before delving into the specifics of 21 CFR Part 812, it's essential to comprehend the concept of an Investigational Device Exemption (IDE). An IDE allows an investigational device to be used in a clinical study to collect data on its safety and effectiveness. It serves as a regulatory mechanism implemented by the U.S. Food and Drug Administration (FDA) to ensure that investigational devices are subjected to appropriate controls and oversight during the research phase.
How IDE is managed under 21 CFR 812?
Under 21 CFR Part 812, the FDA outlines the requirements for obtaining and maintaining an IDE for investigational devices. The regulation establishes a framework for the conduct of clinical studies involving investigational devices, with an emphasis on protecting the rights, safety, and welfare of study participants.
One crucial aspect of managing IDEs under 21 CFR Part 812 is the submission of an IDE application to the FDA. This application includes detailed information about the investigational device, its intended use, study protocols, and plans for ensuring participant safety. Additionally, sponsors must develop an investigational plan that outlines the objectives, methodology, monitoring procedures, and statistical analysis of the clinical study. Institutional Review Board (IRB) approval is also required before initiating the study to ensure that it meets ethical and regulatory standards.
Investigators conducting clinical studies under an IDE are responsible for ensuring compliance with the investigational plan, FDA regulations, and IRB requirements. They must obtain informed consent from study participants, monitor the conduct of the study, and report any adverse events or device deficiencies to the FDA and IRB.
Manufacturers or sponsors are also required to maintain accurate records of the investigational device, including its distribution, use, and disposition. Quality assurance and quality control measures must be implemented to ensure the integrity of the data collected during the clinical study.
Expanding on 21 CFR Part 812 Requirements:
Compliance with 21 CFR Part 812 entails adherence to various requirements aimed at safeguarding the integrity of clinical studies and protecting the rights and safety of study participants. Some key requirements outlined in the regulation include:
Device Labeling: Investigational devices must be appropriately labeled with cautionary statements indicating their investigational status and limitations. Clear labeling helps ensure that study participants and healthcare professionals are aware of the device's experimental nature and potential risks.
Monitoring and Auditing: Sponsors must establish procedures for monitoring the conduct of the clinical study and conducting audits to ensure compliance with the investigational plan and regulatory requirements. Monitoring activities may include site visits, data review, and verification of study procedures.
Adverse Event Reporting: Investigators are required to promptly report any adverse events or device deficiencies observed during the clinical study to the FDA and IRB. Timely reporting allows regulatory authorities to assess the safety profile of the investigational device and take appropriate actions to protect study participants.
Recordkeeping: Manufacturers or sponsors must maintain accurate and complete records of all aspects of the investigational device study, including correspondence with the FDA, IRB approvals, and adverse event reports. Comprehensive recordkeeping facilitates transparency, accountability, and regulatory compliance throughout the duration of the study.
Quality Assurance and Quality Control: Sponsors must implement quality assurance and quality control measures to ensure the integrity of the data collected during the clinical study and the reliability of study results. This may include protocols for data validation, calibration of equipment, and training of study personnel to maintain consistency and accuracy in data collection and analysis.
By adhering to these requirements, manufacturers, sponsors, and investigators can demonstrate their commitment to conducting ethical and scientifically sound clinical research. Compliance with 21 CFR Part 812 helps ensure that investigational devices undergo rigorous evaluation and that study participants are provided with adequate protection and information throughout the research process.
It's important to note that the 21 CFR Part 812 and other submissions such as the 510(k) or PMA all fall under the regulatory framework and they serve distinct purposes and address different stages of the medical device development and approval process.
Implementing a robust Quality Management System (QMS) is not just relevant but essential for compliance with 21 CFR Part 812. Let's explore how a QMS intersects with the requirements of this regulation.
A QMS provides a structured framework for document control, ensuring that all documents related to the investigational device study are managed, version-controlled, and readily accessible. This includes protocols, standard operating procedures (SOPs), investigational plans, and study reports required by 21 CFR Part 812.
In addition, 21 CFR Part 812 mandates that any changes to the investigational plan or study protocols be documented and approved by the Institutional Review Board (IRB) and the FDA. A QMS facilitates change control processes, ensuring that changes are properly evaluated, documented, and implemented in compliance with regulatory requirements.
There are many more examples on why it's important to leverage a QMS when thinking about 21 CFR Part 812. Feel free to discuss this with our specialists at Matrix Requirements.
In conclusion, 21 CFR Part 812 helps to manage the conduct of clinical studies involving investigational devices in the United States. By establishing requirements for IDEs and outlining standards for study conduct, participant protection, and data integrity, this regulation promotes the safe and effective development of medical devices. Adherence to 21 CFR Part 812 helps ensure that investigational devices undergo rigorous evaluation and that study participants are provided with adequate protection and information throughout the research process. Through compliance with these regulatory requirements, manufacturers, sponsors, and investigators can contribute to advancing medical science while upholding the highest standards of ethical and scientific integrity.
If you're looking to accelerate development of your innovative medical device technologies, the Matrix Requirements platform is an easy-to-use, flexible, all-in-one software solution that will help you 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.