| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
065
|
Date of Entry 12/22/2025
|
|
FR Recognition Number
|
10-141
|
| Standard | |
ISO 11978 Third edition 2017-08 [Including AMD1:2020]
Ophthalmic optics - Contact lenses and contact lens care products - Labelling [Including Amendment 1 (2020)] |
|
Scope/Abstract| ISO 11978:2017 specifies the information to be provided by the manufacturer of contact lenses and contact lens care products to ensure the correct and safe use of these devices and their accessories by both types of user of contact lenses: the eye care professional and the contact lens wearer. |
|
| Extent of Recognition
|
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. |
|
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)
|
Class 2
|
MUW
|
| §886.5916 |
Lens, Contact (Rigid Gas Permeable), Extended Wear
|
Class 3
|
MWL
|
| §886.5916 |
Lens, Contact, Orthokeratology, Overnight
|
Class 3
|
NUU
|
| §886.5918 |
Products, Contact Lens Care, Rigid Gas Permeable
|
Class 2
|
MRC
|
| §886.5925 |
Lenses, Soft Contact, Daily Wear
|
Class 2
|
LPL
|
| §886.5925 |
Lenses, Soft Contact, Extended Wear
|
Class 3
|
LPM
|
| §886.5925 |
Lens, Contact, (Disposable)
|
Class 2
|
MVN
|
| §886.5925 |
System, In-Office Tinting, Contact Lenses
|
Class 2
|
MZD
|
| §886.5925 |
Lens, Contact, For Color Vision Deficiency
|
Class 2
|
NCZ
|
| §886.5925 |
Lens, Contact, For Reading Discomfort
|
Class 2
|
NIC
|
| §886.5928 |
Sterilizer, Soft-Lens, Thermal, Battery-Powered
|
Class 2
|
HRC
|
| §886.5928 |
Sterilizer, Soft-Lens, Thermal, Ac-Powered
|
Class 2
|
HRD
|
| §886.5928 |
Accessories, Soft Lens Products
|
Class 2
|
LPN
|
| §886.5928 |
Case, Contact Lens
|
Class 2
|
LRX
|
| §886.5928 |
Accessories, Solution, Ultrasonic Cleaners For Lenses
|
Class 2
|
LYL
|
|
Relevant FDA Guidance and/or Supportive Publications*
1. Premarket Notification [510(k)] Guidance Document for Daily Wear Contact Lenses, issued June 1994.
2. Premarket Notification [510(k)] Guidance Document for Contact Lens Care Products, issued May 1997.
3. ISO 15223-1 Fourth edition 2021-07 Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
|
| FDA Technical Contacts
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
|
|
