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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 10-89: ANSI Z80.7-2013, ophthalmics - intraocular lenses. (Ophthalmic)

Date of Standard: 2013. 
Address of Standards Development Organization:
 American National Standards Institute (ANSI)
  25 West 43rd Street
  4th Floor
  New York, NY 10036
 
CDRH Office and Division associated with recognized standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Intraocular Lenses
Processes Affected:
PMA, IDE, PDP, HDE, Design Control Input
Type of Standard:
 Vertical, National
Extent of Recognition:
Complete standard and any annexes, with the following exceptions:

Clause 8.2.3. is not recognized

For bacterial endotoxin limits for IOLs, contact the review division.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§886.3600 Intraocular Lens Class 3 HQL
Relevant Guidance:
FDA Guidance for Industry Pyrogens and Endotoxins Testing: Questions and Answers, June 2012, Refer to Question 11.
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
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