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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 031 FR Publication Date: 08/05/2013 

Part B: Supplementary Information

Recognition Number 10-79: ISO 11979-1 Third edition 2012-09-15, ophthalmic implants -- intraocular lenses - part 1: vocabulary. (Ophthalmic)

Date of Standard: 2012. 
Address of Standards Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
  SWITZERLAND
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
DIVISION OF OPHTHALMIC AND EAR, NOSE AND THROAT DEVICES (DOED)
Devices Affected:
Intraocular lenses (IOL)
Processes Affected:
510(k), PMA, IDE, PDP, HDE, Design Control Input
Type of Standard:
 International, Vertical
Extent of Recognition:
Complete standard with the following advisory:

5.2 custom-made device
In general, IOLs do not meet the criteria for a custom device unless the change in design represents a new and unique concept that is unlikely to reoccur. See 520(b) of the FD&C Act for the statutory definition of "custom device." Please note that to be a custom device, all of the criteria listed in 520(b) must be met.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§886.3600 Intraocular Lens Class 3 HQL
§886.3600 Lens, Intraocular, Toric Optics Class 3 MJP
§886.3600 Lens, Iris Reconstruction Class 3 NIZ
§886.3600 Lens, Multifocal Intraocular Class 3 MFK
§886.3600 Lens,Intraocular,Accommodative Class 3 NAA
FDA Technical Contact:
 Don Calogero
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2500
  Silver Spring MD 20993
  301/796-6483
  email: don.calogero@fda.hhs.gov
* in the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036
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