Description
For questions regarding this document, contact Dr. Greg Campbell (CDRH) at 301-796-5750 orgreg.campbell@fda.hhs.govor the Office of Communication, Outreach and Development, (CBER) at 1-800-835-4709 or 301-827-1800.
Scope & Applicability
Product Classes
1FDA 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
Stakeholders
1Entity responsible for submitting applications under section 524B
Regulatory Context
Attributes
2statistically justified calculation required in the plan
The overall error rate to be controlled via multiplicity adjustments.
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)
- Investigational Device Exemptions (IDEs) for Devices Indicated for Nocturnal Home Hemodialysis: Guidance for Industry and FDA Staff (Status: Final)
- Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials (PDF Version) (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)