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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 052 Date of Recognition 07/15/2019 
FR Recognition Number 10-116
Standard
ANSI Z80.35-2018
American National Standard for Ophthalmics - Extended Depth of Focus Intraocular Lenses
Scope/Abstract
This standard applies to intraocular lenses (IOLs) whose function is the correction of aphakia, with extended range of focus above a defined functional visual acuity threshold to provide useful distance and intermediate vision with monotonically decreasing visual acuity from the best distance focal point.

This standard addresses specific requirements for Extended Depth of Focus Intraocular Lenses (EDF IOLs) that are not addressed in the normative references, and include vocabulary, optical properties and test methods, mechanical properties and test methods, labeling, biocompatibility, sterility, shelf-life and transport stability, and clinical investigations necessary for this type of device. As with any standard, alternative validated test methods may be used.

Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized
Clause 8.2. Requirements [for sterility/package integrity].
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:

Clause 8.2 is in conflict with an existing published final guidance. See Recommendation #1 under Section V. B. Anterior Segment Solid Devices of the guidance document cited below.
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
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.
FDA Technical Contact
 Don Calogero
  FDA/OMPT/CDRH/ODE/DOED/ICIB/
  301-796-6483
  don.calogero@fda.hhs.gov
Standards Development Organization
ANSI American National Standards Institute https://www.ansi.org/
FDA Specialty Task Group (STG)
Ophthalmic
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