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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Entry 01/30/2014 
FR Recognition Number 2-205
Standard
ISO 14155 Second edition 2011-02-01
Clinical investigation of medical devices for human subjects - Good clinical practice [Including: Technical Corrigendum 1 (2011)]
U.S. Identical Adoption
ANSI AAMI ISO 14155:2011
Clinical investigation of medical devices for human subjects - Good clinical practice [Including: Technical Corrigendum 1 (2011)]
Scope/Abstract
This International Standard addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.

The principles set forth in this International Standard also apply to all other clinical investigations and should be followed as far as possible, considering the nature of the clinical investigation and the requirements of national regulations.

This International Standard 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.

It does not apply to in vitro diagnostic medical devices.

NOTE Standards developed by ISO/TC 194 are intended to be applied to medical devices. Users of this International Standard will need to consider whether other standards and/or requirements also apply to the investigational device(s) under consideration.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Clause 4.7.3.4
Clauses 4.7.4 through 5
Rationale for Recognition
The standard is consistent with FDA's good clinical practice principles and is applicable to medical device clinical investigations conducted internationally (outside the US (OUS)). This standard is recognized in part because, 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 814 - Premarket Approval of Medical Devices ; 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 814 - Premarket Approval of Medical Devices
21 CFR 11 - Electronic Records and Signatures
Relevant FDA Guidance and/or Supportive Publications*
Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies: Guidance for Industry and FDA (2013)

Acceptance of Foreign Clinical Studies: Guidance for Industry (March 2001) http://www.fda.gov/RegulatoryInformation/Guidances/ucm124932.htm

Cooperative Research - Information Sheet: Guidance for Institutional Review Boards and Clinical Investigators

Non-local IRB Review

Recruiting Study Subjects (1998)

Clinical Trial Guidances: Statistical Guidance for Clinical Trials for Non Diagnostic Medical Devices (1996)

Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c): Guidance for Sponsors, Investigators, and Institutional Review Boards (2012)

Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials (2010)

Adverse Event Reporting to IRBs Improving Human Subject Protection

A Guide to Informed Consent - Information Sheet Guidance for Institutional Review Boards and Clinical Investigators

Guidance for Industry: Investigator Responsibilities - Protecting the Rights, Safety, and Welfare of Study Subjects

Guidance for Clinical Investigators, Industry, and FDA Staff - Financial Disclosure by Clinical Investigators (2013)

Oversight of Clinical Investigations -- A Risk-Based Approach to Monitoring: Guidance for Industry (2013)
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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