| Part B: Supplementary Information Sheet (SIS) |
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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/Abstract| This 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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Transition Period
| FDA recognition of ISO 11979-7 Fourth edition 2018-03 [Rec# 10-125], and ANSI Z80.12-2007 (R2022) [Rec# 10-56] will be superseded by recognition of ISO 11979-7 Fifth edition 2024-01 [Rec# 10-135]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 10-125] and [Rec# 10-56] until July 06, 2025. After this transition period, declarations of conformity to [Rec# 10-125] and [Rec# 10-56] will not be accepted. |
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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
|
HQL
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| §886.3600 |
Lens, Multifocal Intraocular
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Class 3
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MFK
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| §886.3600 |
Lens, Intraocular, Accommodative
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Class 3
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NAA
|
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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. |
