United States (FDA)
21 CFR Part 812: Investigational Device Exemptions
Part 812 governs clinical investigations of medical devices in the United States. It lets an investigational device be shipped and used in a study without meeting the requirements that would apply to a marketed device, in exchange for a defined set of protections for subjects and obligations for sponsors, investigators and IRBs.
At a Glance
- Regulation
- 21 CFR Part 812
- Subject
- Investigational Device Exemptions
- Group
- United States (FDA)
- Industries
- 3 industry guides reference it
A plain-language summary, not legal advice. Always read the current official text.
What It Covers
A central idea in Part 812 is the difference between significant risk and non-significant risk studies. A significant risk device study requires an IDE application approved by FDA as well as IRB approval before it can begin. A non-significant risk study is subject to abbreviated requirements, with the IRB playing the main oversight role, though the sponsor still has labeling, monitoring, record and reporting obligations. Some investigations are exempt from most of Part 812 altogether. Getting the risk determination right, and documenting it, is one of the first decisions in a device study.
Sponsors are responsible for selecting qualified investigators, providing them the information they need, obtaining IRB review, monitoring the investigation, controlling the investigational devices, and keeping records and submitting reports. Investigators are responsible for conducting the study according to the investigational plan and signed agreement, protecting subjects' rights and welfare, obtaining informed consent under 21 CFR Part 50, controlling the devices in their care, and keeping accurate records.
Compliance with Part 812 is reviewed through FDA's Bioresearch Monitoring (BIMO) program, which inspects sponsors, clinical investigators and IRBs. Study conduct matters beyond the study itself, because clinical data supports later PMA, De Novo or 510(k) submissions, and data integrity problems can affect what FDA accepts.
Who It Applies To
- Device manufacturers and others sponsoring clinical investigations of devices in the United States
- Clinical investigators and sites running device studies
- Contract research organizations to which a sponsor transfers obligations
- Institutional review boards reviewing device studies, alongside their own regulations
What Auditors Check
Risk Determination
How the study was classified as significant or non-significant risk, who made the determination, and whether it is documented.
Monitoring
Whether the sponsor monitored the study as planned, found deviations, and acted on investigator noncompliance.
Informed Consent
Whether consent was obtained and documented properly for each subject, using the IRB-approved form in effect at the time.
Device Accountability
Records of investigational device shipment, receipt, use, return and disposal, reconciled across sponsor and sites.
Protocol Adherence and Deviations
Whether the study followed the investigational plan, and whether deviations were recorded and reported as required.
Adverse Device Effects and Reports
Whether unanticipated adverse device effects were evaluated and reported, and whether required progress and final reports were submitted.
Related Services
BIMO (Clinical) Inspection Readiness
Readiness for FDA bioresearch monitoring inspections of device clinical studies: sponsors, CROs and sites.
Submission Readiness (510(k), De Novo, PMA, Pre-Sub, 513(g))
The design, risk and V&V evidence behind a 510(k), De Novo or PMA, organized and gap-checked.
QMS Build for Startups (Phased)
A QMS built in phases for a device startup: design controls and risk first, the rest before you need it.
Industry Guides That Reference 21 CFR Part 812
Questions
What is the difference between significant and non-significant risk studies?
A significant risk device study needs an IDE approved by FDA and IRB approval before it starts. A non-significant risk study follows abbreviated requirements, with the IRB providing oversight, though sponsors still carry obligations under Part 812. The determination depends on the device and how it is used in the study, and FDA can disagree with it.
Who inspects device clinical studies?
FDA's Bioresearch Monitoring (BIMO) program inspects sponsors, clinical investigators and IRBs to check that studies protect subjects and produce reliable data. Our BIMO inspection readiness work reviews trial master files, monitoring records and device accountability before an inspection.
Does our QMS matter during a clinical study?
Yes. Design and development work on an investigational device produces records that support later submissions and feed your QMS once the device is marketed. Device accountability, labeling and change control during the study also need to be controlled and documented.
21 CFR Part 812
Check Your Quality System Against 21 CFR Part 812
An AI-assisted first pass maps your existing documents against the requirements in scope, and an advisor reviews every result. Please don't send confidential documents yet: secure upload is set up after onboarding.
