Recognized Consensus Standards: Medical Devices

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 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

Janet Tang

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

Janet.Tang@fda.hhs.gov