Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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045
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Date of Entry 09/21/2016
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FR Recognition Number
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10-101
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Standard | |
ISO 18189 First edition 2016-06-01 Ophthalmic optics - Contact lenses and contact lens care products - Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interactions |
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Scope/AbstractThis International Standard describes an in vitro test method to assess the potential cytotoxic effects that may arise due to interaction of contact lenses with contact lens care solutions. |
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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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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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§886.5925 |
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, 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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21 CFR Part 58 - Good Laboratory Practice for Nonclinical Laboratory Studies |
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Relevant FDA Guidance and/or Supportive Publications*
Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses, Issued May 1994
http://www.fda.gov/RegulatoryInformation/Guidances/ucm080928.htm
Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products, Issued May 1, 1997
http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm080218.pdf
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. |