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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 028 Date of Recognition 03/16/2012 
FR Recognition Number 10-67
Standard
ISO 11986 Second edition 2010-11-01
Ophthalmic optics - Contact lenses and contact lens care products - Guidelines for determination of preservation uptake and release
Extent of Recognition
Complete standard
Transition Period
FDA recognition of ISO 11986 Second edition 2010-11-01 [Rec# 10-67] will be superseded by recognition of ISO 11986 Third edition 2017-11 [Rec# 10-112]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 10-67] until September 28, 2019. After this transition period, declarations of conformity to [Rec# 10-67] 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 Contact
 Joseph C. Hutter
  FDA/OMPT/CDRH/ODE/DOED/ICIB/
  301-796-6499
  joseph.hutter@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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