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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 051 Date of Entry 01/14/2019 
FR Recognition Number 10-86
ISO  14729 First edition 2001-04-15
Ophthalmic optics - Contact lens care products - Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses [Including: Amendment 1 (2010]
This International Standard specifies two test methods for evaluating the antimicrobial activity of products to be marketed for contact lens disinfection by chemical means and for products that are part of a contact lens care regimen.

This International Standard is not applicable to the hygienic management of trial lenses.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
-Subclause 4.1 of Amendment 1, General
-Subclause 5.4 of Amendment 1, Test requirements for contact lens care products without rubbing (or mechanical cleaning) and/or rinsing steps
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.

This standard is recognized in part because:
Subclauses 4.1 and 5.4 both conflict with Panel recommendations, an FDA letter sent to industry, and an existing published final FDA labeling guidance (section 4B), see references listed below.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§886.5918 Products, Contact Lens Care, Rigid Gas Permeable Class 2 MRC
§886.5928 Sterilizer, Soft-Lens, Thermal, Battery-Powered Class 2 HRC
§886.5928 Sterilizer, Soft-Lens, Thermal, Ac-Powered Class 2 HRD
§886.5928 Accessories, Soft Lens Products Class 2 LPN
§886.5928 Case, Contact Lens Class 2 LRX
§886.5928 Accessories, Solution, Ultrasonic Cleaners For Lenses Class 2 LYL
Relevant FDA Guidance and/or Supportive Publications*
1. FDA Ophthalmic Devices Panel (June 10, 2008), minutes available online:

2. FDA letter to industry issued on May 19, 2009, available online: https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/ContactLenses/ucm154976.htm

3. Guidance for Industry and Food and Drug Administration Staff: Contact Lens Care Products Labeling, Issued August 15, 2010.

4. Guidance for Industry: Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products, Issued May 1, 1997.

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
 Scott Steffen
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.