Description
FDA is committed to improving U.S. patient access to new devices by strengthening and streamlining the clinical trial enterprise so that medical device clinical trials are conducted in the U.S. in an efficient and cost-effective manner, while maintaining appropriate patient and research participant protections.
Scope & Applicability
Product Classes
7Example of life-saving but high-risk devices
IVDs mentioned regarding clinical decision-making impact
other noninvestigational trial intervention, e.g., diagnostics
Example of devices intended to yield appearance benefits
FDA intends to assess device cybersecurity based on a number of factors; demonstrate or maintain its safety and effectiveness; ensuring cybersecurity has become essential to FDA’s ability to protect the public health; Cyber-resiliency capabilities for medical devices
clinical investigations requiring IDE applications
Investigational device being evaluated in a clinical study
Stakeholders
7Entity responsible for submitting applications under section 524B
Provides medical confirmation of reactions or events; Identifiable reporter in a safety report; Source of medical record numbers; Role responsible for medical confirmation of events; Person entrusted with the direct or indirect provision of healthcare services
identification of qualified investigators with adequate training
Safety oversight body for interpreting adverse events; Safety oversight body for study design
Individuals who both initiate and conduct an investigation
A licensed physician who submits an expanded access IND and administers the drug.; Physician acting as a sponsor for an individual patient IND; An individual who both initiates and conducts a clinical investigation.; Role that may authorize expanded access protocols
Governs top dose in clinical studies
Regulatory Context
Attributes
8The process of weighing probable benefits against probable risks.
Device characteristics considered in benefit-risk determinations
Device characteristics considered in benefit-risk determinations
Explanation of how the device works/principle of operation; Mechanism of action
Anticipated benefit for subjects in target population
Risk remaining after risk control measures are applied; risk mitigation measures can reduce the residual risk
characterization of the device based on data
Evaluation of product safety and effectiveness
Identified Hazards
Hazards
4Risk to safety of subjects that may trigger a clinical hold
Trials should be designed to rule out a clinically relevant degree of harm
Hazardous and unnecessary exposure from electronic products
Potential for contamination of covered produce; Known or reasonably foreseeable hazards in water
Related CFR Sections (7)
- 21CFR812.3§ 812.3 Definitions.
(a) Act means the Federal Food, Drug, and Cosmetic Act (sections 201-901, 52 Stat. 1040 et seq., as amended ( 21 U.S.C. 301-392 )).Read full regulation →
- 21CFR812.27§ 812.27 Report of prior investigations.
(a) General. The report of prior investigations shall include reports of all prior clinical, animal, and laboratory testing of the device and shall be comprehensive and adequate to justify the proposed investigation.Read full regulation →
- 21CFR812.30§ 812.30 FDA action on applications.
(a) Approval or disapproval. FDA will notify the sponsor in writing of the date it receives an application. FDA may approve an investigation as proposed, approve it with modifications, or disapprove it. An investigation may not begin until:Read full regulation →
- 21CFR50.53§ 50.53 Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition.
Any clinical investigation within the scope described in §§ 50.1 and 56.101 of this chapter in which more than minimal risk to children is presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is Read full regulation →
- 21CFR50.25§ 50.25 Elements of informed consent.
(a) Basic elements of informed consent. In seeking informed consent, the following information shall be provided to each subject:Read full regulation →
- 21CFR812.150§ 812.150 Reports.
(a) Investigator reports. An investigator shall prepare and submit the following complete, accurate, and timely reports:Read full regulation →
- 21CFR812.25§ 812.25 Investigational plan.
The investigational plan shall include, in the following order:Read full regulation →
Related Warning Letters (10)
- 2025-09-09
Clinical Investigator
Shirish M. Gadgeel, M.D.
- 2025-07-15
Clinical Investigator
Mark J. Savant, M.D
- 2025-05-20
Bioresearch Monitoring Program/Institutional Review Board (IRB)
United Health Products, Inc.
- 2025-03-25
Clinical Investigator
Americo F. Padilla, M.D.
- 2024-11-05
Institutional Review Board (IRB)
Armstrong County Memorial Hospital
- 2024-10-22
Clinical Investigator
Namita A. Goyal, M.D.
- 2024-10-08
Institutional Review Board (IRB)
Louisiana State University Health Science Center IRB
- 2024-07-16
Bioresearch Monitoring Program/IRB
Massachusetts Institute of Technology MIT
- 2024-06-18
Clinical Investigator (Sponsor)
Angela D. Ritter, M.D.
- 2024-03-26
Institutional Review Board (IRB)
New York State Psychiatric Institute IRB
See Also (8)
- Unique Device Identification System: Small Entity Compliance Guide: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Adaptive Designs for Medical Device Clinical Studies: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Certificates of Confidentiality: Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff (Status: Final)
- Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry: Guidance for Industry (Status: Final)
- Use of Data Monitoring Committees in Clinical Trials (Status: Draft)
- Orthopedic Non-Spinal Bone Plates, Screws, and Washers - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials (Status: Final)
- Investigational Device Exemptions (IDEs) for Devices Indicated for Nocturnal Home Hemodialysis: Guidance for Industry and FDA Staff (Status: Final)