Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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049
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Date of Entry 06/07/2018
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FR Recognition Number
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10-105
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Standard | |
ISO 11979-8 Third edition 2017-04 Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements |
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Scope/AbstractThis document specifies fundamental requirements for all types of intraocular lenses intended for surgical implantation into the anterior segment of the human eye, excluding corneal implants and transplants. |
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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 |
§886.3600 |
Extended Depth Of Focus Intraocular Lens |
Class 3 |
POE |
§886.3600 |
Intraocular Lens |
Class 3 |
HQL |
§886.3600 |
Lens, Intraocular, Accommodative |
Class 3 |
NAA |
§886.3600 |
Lens, Intraocular, Toric Optics |
Class 3 |
MJP |
§886.3600 |
Lens, Iris Reconstruction |
Class 3 |
NIZ |
§886.3600 |
Lens, Multifocal Intraocular |
Class 3 |
MFK |
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Relevant FDA Guidance and/or Supportive Publications*
Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices - Guidance for Industry and Food and Drug Administration Staff, Issued August 2015.
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. |