Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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056
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Date of Entry 06/07/2021
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FR Recognition Number
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10-125
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Standard | |
ISO 11979-7 Fourth edition 2018-03 Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia |
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Scope/AbstractThis document specifies the particular requirements for the clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia. |
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Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized: |
6.2.2 Additional requirments for toric IOLs
6.3.3 Additional characteristics to be studied for TIOLs
6.4 Duration of the investigation - paragraphs 4 and 5
6.10.2 Additional inclusion criteria for TIOLs
Annex B Additional elements for the clinical investigation of TIOLs |
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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.
This standard is recognized in part because: The clauses and annex above are in conflict with another recognized standard, see clause 10 and Annex B of ANSI Z80.30 listed below. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§886.3600 |
Intraocular Lens
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Class 3
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HQL
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§886.3600 |
Lens, Intraocular, Accommodative
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Class 3
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NAA
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§886.3600 |
Lens, Multifocal Intraocular
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Class 3
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MFK
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Relevant FDA Guidance and/or Supportive Publications*
ANSI Z80.30 - 2018 American National Standard for Ophthalmics - Toric Intraocular Lenses.
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. |