| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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031
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Date of Entry 08/06/2013
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FR Recognition Number
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10-77
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| Standard | |
ISO 9394 Third edition 2012-10-01
Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes |
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Scope/Abstract| This International Standard specifies an in vivo method of test to assess the ocular safety of both novel contact lens material and contact lens care products. The test assesses the degree of irritation to the ocular tissue produced by the device under test. The test method is described in application to rabbit eyes. |
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| 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. |
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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)
|
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*
Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses, Issued May 1994
Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products, Issued May 1, 1997
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
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
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