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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 026 Date of Entry 03/18/2011 
FR Recognition Number 10-63
ISO TR 22979 First edition 2006-02-01
Ophthalmic implants - Intraocular lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
ISO/TR 22979:2006 provides guidance on the application of Parts 3, 7 and 9 of the ISO 11979 series of International Standards for intraocular lenses (IOLs). It addresses factors to be considered in a risk analysis of the significance of modifications to anterior and posterior chamber, monofocal and multifocal, intraocular lenses. It also suggests methods of data analysis and interpretation that can be used to determine the need for and the design of a clinical investigation.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Transition Period
FDA recognition of ISO/TR 22979 First edition 2006-02-01 [Rec# 10-63] will be superseded by recognition of ISO/TR 22979 Second Edition 2017-05 [Rec# 10-120]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 10-63] until December 19, 2021. After this transition period, declarations of conformity to [Rec# 10-63] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§886.3600 Intraocular Lens Class 3 HQL
§886.3600 Lens, Multifocal Intraocular Class 3 MFK
FDA Technical Contact
 Don Calogero
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.