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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 055 Date of Entry 12/21/2020 
FR Recognition Number 10-120
Standard
ISO TR 22979 Second Edition 2017-05
Ophthalmic implants - Intraocular Lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
Scope/Abstract
ISO/TR 22979:2017 provides guidance on the application of all parts of the ISO 11979 series of International Standards for intraocular lenses (IOLs).[19] It addresses factors to be considered in the risk management process of modifications to anterior and posterior chamber IOLs in accordance with ISO 14971.[11] It also suggests methods of data analysis and interpretation that can be used to determine the need for a clinical investigation and its design.
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FDA recognition of ISO/TR 22979 First edition 2006-02-01 [Rec# 10-63] will be superseded by recognition of ISO/TR 22979 Second Edition 2017-05 [Rec# 10-120].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 Extended Depth Of Focus Intraocular Lens Class 3 POE
§886.3600 Intraocular Lens Class 3 HQL
§886.3600 Lens, Intraocular, Accommodative Class 3 NAA
§886.3600 Lens, Intraocular, Toric Optics Class 3 MJP
§886.3600 Lens, Multifocal Intraocular Class 3 MFK
FDA Technical Contact
 Don Calogero
  FDA/OC/CDRH/OPEQ/OHTI/DHTIA/
  301-796-6483
  don.calogero@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Ophthalmic
*These are provided as examples and others may be applicable.
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