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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Recognition 01/14/2019 
FR Recognition Number 10-85
Standard
ISO 11980 Third edition 2012-11-15 Corrected version 2012-12-01
Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations
Scope/Abstract
This International Standard gives guidelines for the clinical investigation (CI) of the safety and performance of contact lenses and contact lens care products.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized
-Table A.1 of Annex A.2.1 Contact lens investigations
-Annex A.2.3 Statistical considerations for extended wear evaluations
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.

This standard is recognized in part because:
-Table A.1 conflicts with an existing published final guidance for orthokeratology; see Section 3 of guidance #3 below. See also reference #4 below (Walline et al) regarding study duration.
-Annex A.2.3 does not satisfy a premarket requirement under the FD&C Act for these devices.
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
1. Premarket Notification [510(k)] Guidance Document for Daily Wear Contact Lenses, Issued May 1994.

2. Guidance for Industry: Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products, Issued May 1, 1997.

3. Guidance for Industry: Guidance for Premarket Submissions of Orthokeratology Rigid Gas Permeable Contact Lenses, Issued April 10, 2000.

4. Walline JJ, et al., Food and Drug Administration, American Academy of Ophthalmology, American Academy of Optometry, American Association for Pediatric Ophthalmology and Strabismus, American Optometrix Association, American Society of Cataract and Refractive Surgery, and Contact Lens Association of Ophthalmologists Co-Sponsored Workshop: Controlling the Progression of Myopia: Contact Lenses and Future Medical Devices. Eye Contact Lens, 2018 Jul, 44(4):205-211.
FDA Technical Contact
 Gene Hilmantel
  FDA/OMPT/CDRH/ODE
  301-796-6497
  Gene.Hilmantel@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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