| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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051
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Date of Entry 01/14/2019
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FR Recognition Number
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10-85
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| 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 |
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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. |
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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 |
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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. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §886.5916 |
Lens, Contact (Other Material) - Daily
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Class 2
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HQD
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| §886.5916 |
Lens, Contact (Orthokeratology)
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Class 2
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MUW
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| §886.5916 |
Lens, Contact (Rigid Gas Permeable), Extended Wear
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Class 3
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MWL
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| §886.5916 |
Lens, Contact, Orthokeratology, Overnight
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Class 3
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NUU
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| §886.5918 |
Products, Contact Lens Care, Rigid Gas Permeable
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Class 2
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MRC
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| §886.5925 |
Lenses, Soft Contact, Daily Wear
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Class 2
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LPL
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| §886.5925 |
Lenses, Soft Contact, Extended Wear
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Class 3
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LPM
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| §886.5925 |
Lens, Contact, (Disposable)
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Class 2
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MVN
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| §886.5925 |
System, In-Office Tinting, Contact Lenses
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Class 2
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MZD
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| §886.5925 |
Lens, Contact, For Color Vision Deficiency
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Class 2
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NCZ
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| §886.5925 |
Lens, Contact, For Reading Discomfort
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Class 2
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NIC
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| §886.5928 |
Sterilizer, Soft-Lens, Thermal, Battery-Powered
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Class 2
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HRC
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| §886.5928 |
Sterilizer, Soft-Lens, Thermal, Ac-Powered
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Class 2
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HRD
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| §886.5928 |
Accessories, Soft Lens Products
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Class 2
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LPN
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| §886.5928 |
Case, Contact Lens
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Class 2
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LRX
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| §886.5928 |
Accessories, Solution, Ultrasonic Cleaners For Lenses
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Class 2
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LYL
|
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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.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contact
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
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