Recognized Consensus Standards: Medical Devices

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.

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	Extended Depth Of Focus Intraocular Lens	Class 3	POE

Relevant FDA Guidance and/or Supportive Publications*

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 Contacts

Simona Bancos

FDA/OC/CDRH/OPEQ/OHTI/DHTIA/

301-796-2243

simona.bancos@fda.hhs.gov

Bennett Walker

FDA/OC/CDRH/OPEQ/OHTI/DHTIA/

301-796-5093

Bennett.Walker@fda.hhs.gov

Aisha Traish

FDA/OC/CDRH/OPEQ/OHTI/DHTIA/

Aisha.Traish@fda.hhs.gov