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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 055 Date of Entry 12/21/2020 
FR Recognition Number 2-282
Standard
ISO 14155 Third edition 2020-07 Clinical investigation of medical devices for human subjects - Good clinical practice
Scope/Abstract
This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.
For post-market clinical investigations, the principles set forth in this document are intended to be followed as far as relevant, considering the nature of the clinical investigation (see Annex I).
This document specifies general requirements intended to
- protect the rights, safety and well-being of human subjects,
- ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results,
- define the responsibilities of the sponsor and principal investigator, and
- assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
NOTE 1 Users of this document need to consider whether other standards and/or national requirements also apply to the investigational device(s) under consideration or the clinical investigation. If differences in requirements exist, the most stringent apply.
NOTE 2 For Software as a Medical Device (SaMD) demonstration of the analytical validity (the SaMD's output is accurate for a given input), and where appropriate, the scientific validity (the SaMD's output is associated to the intended clinical condition/physiological state), and clinical performance (the SaMD's output yields a clinically meaningful association to the target use) of the SaMD, the requirements of this document apply as far as relevant (see Reference [4]). Justifications for exemptions from this document can consider the uniqueness of indirect contact between subjects and the SaMD.
This document does not apply to in vitro diagnostic medical devices. However, there can be situations, dependent on the device and national or regional requirements, where users of this document might consider whether specific sections and/or requirements of this document could be applicable.
Extent of Recognition
Complete standard
Rationale for Recognition
The standard is consistent with FDA's good clinical practice regulations and is applicable to medical device clinical investigations conducted internationally (outside the US (OUS)) and submitted in support of a research or marketing application. Users of this standard should be aware of FDA's requirements for the acceptance of clinical data from studies conducted OUS at 21 CFR 812.28. Additionally, for medical device clinical investigations conducted in the US, the following US good clinical practice regulations apply: 21 CFR 50 - Protection of Human Subjects; 21 CFR 812 - Investigational Device Exemptions; 21 CFR 56 - Institutional Review Boards; 21 CFR 54 - Financial Disclosure by Clinical Investigators; 21 CFR 11 - Electronic Records and Signatures.
Transition Period
FDA recognition of ISO 14155 Second edition 2011-02-01 [Rec# 2-205] will be superseded by recognition of ISO 14155 Third edition 2020-07 [Rec# 2-282]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 2-205] until December 18, 2022. After this transition period, declarations of conformity to [Rec# 2-205] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
21 CFR 50 - Protection of Human Subjects
21 CFR 812 - Investigational Device Exemptions
21 CFR 56 - Institutional Review Boards
21 CFR 54 - Financial Disclosure by Clinical Investigators
21 CFR 11 - Electronic Records and Signatures
Relevant FDA Guidance and/or Supportive Publications*
1. Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions
2. Guidance for Sponsors, Investigators, and Institutional Review Boards Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c) (Small Entity Compliance Guide)
3. Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff
4. Guidance for Industry Computerized Systems Used in Clinical Investigations
5. Information Sheet - Guidance For IRBs, Clinical Investigators, and Sponsors Significant Risk and Nonsignificant Risk Medical Device Studies
6. Design Considerations for Pivotal Clinical Investigations for Medical Devices - Guidance for Industry, Clinical Investigators, Institutional Review Boards and FDA Staff
7. Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring
8. Investigator Responsibilities - Protecting the Rights, Safety, and Welfare of Study Subjects
9. Information Sheet - Institutional Review Boards Frequently Asked Questions Guidance for Institutional Review Boards and Clinical Investigators
10. Use of Electronic Informed Consent in Clinical Investigations - Questions and Answers
11. Electronic Source Data in Clinical Investigations
12. Establishment and Operation of Clinical Trial Data Monitoring Committees - Guidance for Clinical Trial Sponsors
13. Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials - Guidance for Sponsors, Clinical Investigators, and IRBs
14. Exception from Informed Consent Requirements for Emergency Research - Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors
15. IRB Continuing Review After Clinical Investigation Approval - Guidance for IRBs, Clinical Investigators, and Sponsors
16. IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed - Guidance for IRBs, Clinical Investigators, and Sponsors
17. Part 11, Electronic Records; Electronic Signatures - Scope and Application
18. Information Sheet - Cooperative Research Guidance for Institutional Review Boards and Clinical Investigators
19. Information Sheet - Non-local IRB Review Guidance for Institutional Review Boards and Clinical Investigators
20. Information Sheet - Recruiting Study Subjects Guidance for Institutional Review Boards and Clinical Investigators
21. Information Sheet - Sponsor - Investigator - IRB Interrelationship Guidance for Institutional Review Boards and Clinical Investigators
22. Information Sheet - Payment and Reimbursement to Research Subjects Guidance for Institutional Review Boards and Clinical Investigators
23. Information Sheet - A Guide to Informed Consent Guidance for Institutional Review Boards and Clinical Investigators
24. Guidance for Clinical Investigators, Sponsors, and IRBs - Adverse Event Reporting to IRBs - Improving Human Subject Protection
25. Guidance for Clinical Investigators, Industry, and FDA Staff Financial Disclosure by Clinical Investigators
26. IRB Continuing Review After Clinical Investigation Approval - Guidance for IRBs, Clinical Investigators, and Sponsors
FDA Technical Contacts
 Jayna Wiebel
  CDRH/OPEQ/OCEA/DCEAI
  --
  Jayna.Wiebel@fda.hhs.gov
 Pablo Morales
  CDRH/OPEQ/OCEA
  --
  Jose.Morales@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Biocompatibility
*These are provided as examples and others may be applicable.
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