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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 034 Date of Entry 01/30/2014 
FR Recognition Number 10-88
Standard
ASTM D790-10
Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
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.
Transition Period
FDA recognition of ASTM D790-10 [Rec# 10-88] will be superseded by recognition of ASTM D790-17 [Rec# 10-129]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 10-88] until December 18, 2022. After this transition period, declarations of conformity to [Rec# 10-88] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
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 FDA Guidance and/or Supportive Publications*
Premarket Notification (510k) Guidance Document for Daily Wear Contact Lenses, Issued May 1994.
FDA Technical Contact
 Joseph C. Hutter
  FDA/OC/CDRH/OPEQ/OHTI/DHTIA/
  301-796-6499
  joseph.hutter@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Ophthalmic
*These are provided as examples and others may be applicable.
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