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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 050 Date of Recognition 09/17/2018 
FR Recognition Number 10-111
Standard
ISO 11981 Third edition 2017-11
Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lens care products with contact lenses
Scope/Abstract
This document describes the general procedure and performance criteria for assessing the physical compatibility of contact lens care products with contact lenses and for determining whether the observed changes are reversible.
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FDA recognition of ISO 11981 Second edition 2009-07-01 [Rec# 10-60] will be superseded by recognition of ISO 11981 Third edition 2017-11 [Rec# 10-111]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 10-60] until September 28, 2019. After this transition period, declarations of conformity to [Rec# 10-60] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)
Regulation Number Device Name Device Class Product Code
§886.5928 Accessories, Soft Lens Products Class 2 LPN
§886.5928 Accessories, Solution, Ultrasonic Cleaners For Lenses Class 2 LYL
§886.5928 Case, Contact Lens Class 2 LRX
§886.5928 Sterilizer, Soft-Lens, Thermal, Ac-Powered Class 2 HRD
§886.5928 Sterilizer, Soft-Lens, Thermal, Battery-Powered Class 2 HRC
§886.5925 Lens, Contact, (Disposable) Class 2 MVN
§886.5925 Lens, Contact, For Color Vision Deficiency Class 2 NCZ
§886.5925 Lens, Contact, For Reading Discomfort Class 2 NIC
§886.5925 Lenses, Soft Contact, Daily Wear Class 2 LPL
§886.5925 Lenses, Soft Contact, Extended Wear Class 3 LPM
§886.5925 System, In-Office Tinting, Contact Lenses Class 2 MZD
§886.5918 Products, Contact Lens Care, Rigid Gas Permeable Class 2 MRC
§886.5916 Lens, Contact (Orthokeratology) Class 2 MUW
§886.5916 Lens, Contact (Other Material) - Daily Class 2 HQD
§886.5916 Lens, Contact (Rigid Gas Permeable), Extended Wear Class 3 MWL
§886.5916 Lens, Contact, Orthokeratology, Overnight Class 3 NUU
Relevant FDA Guidance and/or Supportive Publications
Premarket Notification [510(k)] Guidance Document for Daily Wear Contact Lenses, Issued May 1994.

Guidance for Industry Premarket Notification [510(k)] Guidance Document for Contact Lens Care Products, Issued May 1997.
FDA Technical Contacts
 Joseph C. Hutter
  FDA/OMPT/CDRH/ODE/DOED/ICIB/
  301-796-6499
  joseph.hutter@fda.hhs.gov
 Yasith Nanayakkara
  FDA/OMPT/CDRH/ODE/DOED/CLRD/
  301-796-5029
  yasith.nanayakkara@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Ophthalmic
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