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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 056 Date of Entry 06/07/2021 
FR Recognition Number 10-125
ISO  11979-7 Fourth edition 2018-03
Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia
This document specifies the particular requirements for the clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia.
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
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§886.3600 Intraocular Lens Class 3 HQL
§886.3600 Lens, Intraocular, Accommodative Class 3 NAA
§886.3600 Lens, Multifocal Intraocular Class 3 MFK
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.
FDA Technical Contact
 Don Calogero
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.