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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 047 Date of Entry 08/21/2017 
FR Recognition Number 10-104
Standard
ANSI  Z80.20-2016 (R2021)
American National Standard for Ophthalmics - Contact Lenses - Standard Terminology, Tolerances, Measurements and Physicochemical Properties
Scope/Abstract
Applies to contact lenses worn over the front surface of the eye in contact with the preocular tear film. The standard covers rigid intracorneal and haptic (scleral) contact lenses, as well as soft paralimbal contact lenses.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Subclause 5.1, paragraph 2 - Deviations from manufacturing tolerances
Rationale for Recognition
This standard is recognized on a scientific basis: performance specification.

NOTE: Although the standard states the tolerances might not apply beyond the time of manufacture, manufacturers may use this standard for the purposes of finished product specifications and shelf-life studies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§886.5925 Lenses, Soft Contact, Daily Wear Class 2 LPL
§886.5925 Lenses, Soft Contact, Extended Wear Class 3 LPM
§886.5925 Lens, Contact, (Disposable) Class 2 MVN
Relevant FDA Guidance and/or Supportive Publications*
1. Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses, Issued May 1994.

2. ISO 18369-1 Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications.

3. ISO 18369-2 Ophthalmic optics - Contact lenses - Part 2: Tolerances.

4. ISO 18369-3 Ophthalmic optics - Contact lenses - Part 3: Measurement Methods.

5. ISO 18369-4 Ophthalmic optics - Contact lenses - Part 4: Physicochemical properties of contact lens materials.

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
 J. Angelo Green
  FDA/OC/CDRH/OPEQ/OHTI/DHTIA/
  301-796-6860
  angelo.green@fda.hhs.gov
Standards Development Organization
ANSI American National Standards Institute https://www.ansi.org/
FDA Specialty Task Group (STG)
Ophthalmic
*These are provided as examples and others may be applicable.
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