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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Recognition 01/30/2014 
FR Recognition Number 10-60
ISO 11981 Second edition 2009-07-01
Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lens care products with contact lenses
Extent of Recognition
Complete standard
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FDA recognition of ISO 11981 Second edition 2009-07-01 [Rec# 10-60] will be superseded by recognition of ISO 11981 Third edition 2017-11 [Rec# 10-111].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, May 12, 1994.

Guidance for Industry Premarket Notification [510(k)] Guidance Document for Contact Lens Care Products, May 1, 1997.

Green, J.A., Phillips, K.S., Hitchins, V.M., Lucas, A.D., Shoff, M.E., Hutter, J.C., Rorer, E.M., & Eydelman, MB. (2012). Material properties that predict preservative uptake for silicone hydrogel contract lenses. Eye and Contact Lens, 38 (6), 350-357.

Hutter, J.C., Green, J.A., & Eydelman, M.B. (2012). Proposed Silicone Hydrogel Contact Lens Grouping System for Lens Care Product Compatibility Testing. Eye and Contact Lens, 38(6), 358-362.
FDA Technical Contact
 Joseph C. Hutter
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)