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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 031 Date of Entry 08/06/2013 
FR Recognition Number 10-79
Standard
ISO 11979-1 Third edition 2012-09-15
Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary
Scope/Abstract
This part of ISO 11979 defines terms applicable to intraocular lenses and to the methods used to evaluate them.
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FDA recognition of ISO 11979-1 Third edition 2012-09 [Rec# 10-79] will be superseded by recognition of ISO 11979-1 Fourth edition 2018-11 [Rec# 10-124]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 10-79] until July 10, 2022. After this transition period, declarations of conformity to [Rec# 10-79] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
Unclassified Lens, Intraocular, Phakic Class 3 MTA
§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, Iris Reconstruction Class 3 NIZ
§886.3600 Lens, Multifocal Intraocular Class 3 MFK
§886.3600 Phakic Toric Intraocular Lens Class 3 QCB
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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