Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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034
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Date of Entry 01/30/2014
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FR Recognition Number
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10-87
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Standard | |
ASTM D882-12 Standard Test Methods for Tensile Properties of Thin Plastic Sheeting |
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Extent of Recognition
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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. |
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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FDA recognition of ASTM D882-12 [Rec# 10-87] will be superseded by recognition of ASTM D882-18 [Rec# 10-128].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.
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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 |
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Relevant FDA Guidance and/or Supportive Publications*
Premarket Notification (510k) Guidance Document for Daily Wear Contact Lenses, Issued May 1994. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |