| 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
|
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| FDA recognition of ASTM D790-10 [Rec# 10-88] will be superseded by recognition of ASTM D790-17 [Rec# 10-129].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
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
|
|
| *These are provided as examples and others may be applicable. |
