• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 

New Search Back To Search Results
Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 10-88: ASTM D790-10, standard test methods for flexure properties of unreinforced plastics and electrical insulating materials. (Ophthalmic)

Date of Standard: 2010. 
Address of Standards Development Organization:
 ASTM International (ASTM)
  100 Barr Harbor Drive
  West Conshohocken, PA 19428-2959
 
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:
Rigid gas permeable contact lenses
Processes Affected:
510(k), PMA, IDE
Type of Standard:
 Horizontal, International
Extent of Recognition:
Complete standard and any annexes.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§886.5916 Lens, Contact (Other Material) - Daily Class 2 HQD
§886.5916 Lens,Contact(Rigid Gas Permeable)-Extended Wear Class 3 MWL
Relevant Guidance:
Premarket Notification (510k) Guidance Document for Daily Wear Contact Lenses, Issued May 1994
FDA Technical Contact:
 Joseph C. Hutter
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2458
  Silver Spring MD 20993
  301/796-6499
  email: joseph.hutter@fda.hhs.gov
-
-