| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
034
|
Date of Entry 01/30/2014
|
|
FR Recognition Number
|
10-87
|
| Standard | |
ASTM D882-12
Standard Test Methods for Tensile Properties of Thin Plastic Sheeting |
|
| 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FDA recognition of ASTM D882-12 [Rec# 10-87] will be superseded by recognition of ASTM D882-18 [Rec# 10-128]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 10-87] until December 18, 2022. After this transition period, declarations of conformity to [Rec# 10-87] will not be accepted.
|
|
Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §886.5925 |
Lens, Contact, (Disposable) |
Class 2 |
MVN |
| §886.5925 |
Lenses, Soft Contact, Daily Wear |
Class 2 |
LPL |
| §886.5925 |
Lenses, Soft Contact, Extended Wear |
Class 3 |
LPM |
|
Relevant FDA Guidance and/or Supportive Publications*
Premarket Notification (510k) Guidance Document for Daily Wear Contact Lenses, Issued May 1994.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
|
| FDA Technical Contact
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
|
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| *These are provided as examples and others may be applicable. |
