| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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065
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Date of Entry 12/22/2025
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|
FR Recognition Number
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10-139
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| Standard | |
ISO 11980 Fourth edition 2025-06
Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations |
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Scope/AbstractThis document gives requirements and guidelines for the clinical investigation (CI) to establish the safety and performance of contact lenses and contact lens care products.
NOTE 1 This document attempts to align the recognised regulatory requirements for the conduct of a CI to meet the marketing and labelling requirements for contact lenses and contact lens care products around the world. However, national requirements vary greatly. Wherever national practice or regulations dictate some legal requirement, this requirement takes precedence over this document.
NOTE 2 For indications beyond correction of refractive error, additional considerations for safety and performance are to be included in the clinical investigation plan (CIP). |
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| Extent of Recognition
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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. |
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Transition Period
| FDA recognition of ISO 11980 Third edition 2012-11-15 Corrected version 2012-12-01 [Rec# 10-85] will be superseded by recognition of ISO 11980 Fourth edition 2025-06 [Rec# 10-139]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 10-85] until December 19, 2027. After this transition period, declarations of conformity to [Rec# 10-85] will not be accepted. |
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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
|
Class 2
|
HQD
|
| §886.5916 |
Lens, Contact (Orthokeratology)
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Class 2
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MUW
|
| §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
|
| §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
|
| §886.5925 |
System, In-Office Tinting, Contact Lenses
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Class 2
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MZD
|
| §886.5925 |
Lens, Contact, For Color Vision Deficiency
|
Class 2
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NCZ
|
| §886.5925 |
Lens, Contact, For Reading Discomfort
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Class 2
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NIC
|
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Relevant FDA Guidance and/or Supportive Publications*
Premarket Notification [510(k)] Guidance Document for Daily Wear Contact Lenses, issued June 1994.
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 Contacts
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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. |
