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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 051 Date of Entry 01/14/2019 
FR Recognition Number 10-115
Standard
ANSI Z80.29-2015 American National Standard for Ophthalmics - Accomodative Intraocular Lenses
Scope/Abstract
This standard applies to any ocular implant whose primary indication is the correction of aphakia and is designed to provide vision over a continuous range of distances by affecting a change in the vergence power of the eye resulting from the implant design that changes eye optical power or implant position in response to a stimulus. For the purposes of this standard, these implants are referred to as accommodative intraocular lenses (AIOLs).
Extent of Recognition
Complete standard
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§886.3600 Lens, Intraocular, Accommodative Class 3 NAA
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 17, 2015.

FDA Technical Contact
 Don Calogero
  FDA/OC/CDRH/OPEQ/OHTI/DHTIA/
  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
*These are provided as examples and others may be applicable.
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