Description
This guidance provides FDA's current thinking on use of baysian statistics in medical device clinical trials.
Scope & Applicability
Product Classes
2FDA 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
specific device type mentioned in historical control methods
Stakeholders
6A body that may question the prior information used in a Bayesian analysis.; members who must agree with opinions used to generate priors
Entity responsible for submitting applications under section 524B
Agency staff who do not review sample submissions
Consulted by lead reviewer for checklist completion
Engineers should be satisfied that design or manufacturing differences do not alter performance
Provides clinical judgment and conducts assessments for ClinROs.
Regulatory Context
Attributes
10statistically justified calculation required in the plan
summary computed to quantify efficiency gained from prior information
FDA strongly encourages reporting of credible intervals for Bayesian trials in the labeling.
A parameter required for sample size calculation.
probability of erroneously disapproving a safe and effective device
Statistical parameter requiring strong control when testing multiple endpoints
demographic and prognostic variables used for statistical adjustments
Evidence of benefit from everyday medical practice.
characterizing the safety of individual drugs
Measures of safety and effectiveness used to support a certain claim
Related CFR Sections (2)
- 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 →
- 21CFR812.20§ 812.20 Application.
(a) Submission.Read full regulation →
See Also (8)
- 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)
- The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling : Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions: Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators and Food and Drug Administration Staff (Status: Final)
- Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Study of Sex Differences in the Clinical Evaluation of Medical Products (Status: Draft)