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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 049 Date of Entry 06/07/2018 
FR Recognition Number 10-105
Standard
ISO  11979-8 Third edition 2017-04
Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements
Scope/Abstract
This document specifies fundamental requirements for all types of intraocular lenses intended for surgical implantation into the anterior segment of the human eye, excluding corneal implants and transplants.
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.
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
§886.3600 Lens, Intraocular, Toric Optics Class 3 MJP
§886.3600 Lens, Intraocular, Accommodative Class 3 NAA
§886.3600 Lens, Iris Reconstruction Class 3 NIZ
§886.3600 Extended Depth Of Focus Intraocular Lens Class 3 POE
Relevant FDA Guidance and/or Supportive Publications*
Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices - Guidance for Industry and Food and Drug Administration Staff, Issued August 2015.


Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
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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