Contains Nonbinding Recommendations
Soft (Hydrophilic) Daily Wear Contact 
Lenses  Performance Criteria for 
Safety and Performance Based 
Pathway
______________________________________________________________________________
Guidance for Industry and
Food and Drug Administration Staff
Document issued on March 28, 2023.
The draft of this documents was issued on March 4, 2020.
For questions about this document, contact the DHT1A: Division of Ophthalmic Devices at 301-
796-5620.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
1 Contains Nonbinding Recommendations
Preface
Public Comment
You may submit electronic comments and suggestions at any time for Agency consideration to 
https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food 
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852. 
Identify all comments with the docket number FDA-2019-D-4843. Comments may not be acted 
upon by the Agency until the document is next revised or updated.
Additional Copies
Additional copies are available from the Internet.  You may also send an e-mail request to 
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please use the document 
number GUI00019022 and complete title of the guidance in the request.
2 Contains Nonbinding Recommendations
Soft (Hydrophilic) Daily Wear Contact 
Lenses  Performance Criteria for 
Safety and Performance Based 
Pathway
______________________________________________________________________________
Guidance for Industry and
Food and Drug Administration Staff
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic.  It does not establish any rights for any person and is not binding on 
FDA or the public.  You can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff 
or Office responsible for this guidance as listed on the title page.
I. Introduction 
This guidance provides performance criteria for soft (hydrophilic) daily wear contact lenses in 
support of the Safety and Performance Based Pathway.1 Under this framework, submitters (you) 
planning to submit a 510(k) using the Safety and Performance Based Pathway for soft 
(hydrophilic) contact lenses will have the option to use the performance criteria proposed in this 
guidance to support substantial equivalence, rather than a direct comparison of the performance 
of the subject device to that of a predicate device.
For the current edition of the FDA-recognized consensus standard(s) referenced in this 
document, see the FDA Recognized Consensus Standards Database.2 For more information 
regarding use of consensus standards in regulatory submissions, please refer to the FDA 
guidance entitled Appropriate Use of Voluntary Consensus Standards in Premarket Submissions 
for Medical Devices.3  
In general, FDA's guidance documents, including this guidance, do not establish legally 
enforceable responsibilities. Instead, guidances describe the Agencys current thinking on a topic 
1Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-and-performance-
based-pathway.
2Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.
3Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-
voluntary-consensus-standards-premarket-submissions-medical-devices.
3 Contains Nonbinding Recommendations
and should be viewed only as recommendations, unless specific regulatory or statutory 
requirements are cited. The use of the word should in Agency guidance means that something is 
suggested or recommended, but not required. 
II. Background 
In September 2019, FDA issued a guidance to describe an optional pathway  the Safety and 
Performance Based Pathway4  for certain, well understood device types, where a submitter 
could demonstrate that a new device meets FDA-identified performance criteria to demonstrate 
that the device is as safe and effective as a legally marketed device. In order to identify the 
specific set of performance criteria appropriate to satisfy a submitters comparison to an 
appropriate predicate for a given device-type, FDA has determined that the performance criteria 
represent performance that meets the performance of one or more existing, legally marketed 
devices of that device type. Specifically, FDA relied on the experience and expertise of FDA 
staff, information in literature, and analyses of data available to FDA on legally marketed soft 
(hydrophilic) daily wear contact lenses to determine the performance criteria and associated 
testing methods that could support a finding of substantial equivalence for soft (hydrophilic) 
daily wear contact lenses as described in this guidance. FDA recognizes that in some cases, it 
may be more burdensome for a submitter to conduct testing against an appropriate predicate 
device to demonstrate equivalence for the necessary set of performance and technological 
characteristics than to demonstrate their device meets appropriate performance criteria 
established by FDA. Accordingly, we concluded that the optional device-specific Safety and 
Performance Based Pathway utilizing the performance criteria identified in this guidance 
provides a less burdensome policy consistent with the public health.
III. Scope/Device Description 
The soft (hydrophilic) daily wear contact lenses that are the subject of this guidance are Class II 
devices and are regulated under 21 CFR 886.5925, with the product code LPL.  
 
Intended Use/Indications for Use:
The soft (hydrophilic) daily wear contact lenses that fall within the scope of this guidance are 
prescription devices intended to be worn directly against the cornea and adjacent limbal and 
scleral areas of the eye for the optical correction of ametropia (myopia or hyperopia with or 
without astigmatism). The lenses are designed to be frequent replacement or daily disposable 
lenses.
Soft (hydrophilic) contact lenses with the following indications for use and/or characteristics are 
outside the scope of this guidance:
 To correct presbyopia
 To enhance or alter the apparent color of the eye
 To act as a bandage or therapeutic lens
4Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-and-performance-
based-pathway. 
4 Contains Nonbinding Recommendations
 For the management of keratoconus or irregular corneal conditions
 Lenses with special optical performance beyond that of correcting ametropia (e.g., blue 
light filtering)
 Lenses with special physical performance (e.g., retains moisture, lubricates, reduces 
deposits)
 Lenses with special health performance characteristics (e.g., relieves dry eye)
Device Design Characteristics:
The soft (hydrophilic) daily wear contact lenses that fall within the scope of this guidance are 
spherical or toric lenses made from polymacon, etafilcon A or hioxifilcon D polymeric 
materials as defined by the United States Adopted Name (USAN) Council and include the 
associated primary packaging components. Polymacon, etafilcon A, and hioxilfilcon D 
represent well-established contact lens materials that have been used in many 510(k)s by 
numerous contact lens manufacturers. Listed color additives5 are used for handling and 
visibility tinting only. The lenses are designed to be frequent replacement or daily disposable 
lenses.
Please note that the scope of this guidance document does not include rigid gas permeable 
contact lenses (21 CFR 886.5918) or soft contact lens materials that have not been specified in 
the scope of this document. 
In addition, soft (hydrophilic) daily wear contact lenses with the following features are outside 
the scope of this guidance:
 Lenses made of materials not defined above
 Lens materials made of non-polymeric components
 Lens materials with non-listed color additives
 Lenses with UV-additives not previously used in polymacon, etafilcon A or hioxifilcon D 
materials
 Lenses with coatings, whether directly or indirectly applied (e.g., wetting agents applied 
by immersion in packaging solution)
 Lenses with novel packaging solution ingredients not used in any previously marketed 
contact lens packaging solution or care product
 Lens materials with special optical filtering capabilities (e.g., blue light filtering)
 Lenses with new spherical or toric optical designs that have not previously been marketed
 Combination products
Some of the recommendations in this safety and performance guidance may assist in complying 
with some of the special controls for soft daily wear contact lenses. For information regarding 
the special controls for soft daily wear contact lenses, see Premarket Notification [510(k)] 
Guidance Document for Class II Daily Wear Contact Lenses.6 Descriptive information such as  
that related to the device description, United States Adopted Name Council (USAN) designation, 
finished lens parameters and tolerances and general manufacturing information should be 
5See 21 CFR Part 73 Subpart D.
6Available athttps://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-
products/class-ii-daily-wear-contact-lenses-premarket-notification-510k-guidance-document.
5 Contains Nonbinding Recommendations
provided as recommended in the above guidance. Similarly, general information that is beyond 
the scope of this safety and performance guidance document regarding submission of a 510(k) 
for daily wear contact lenses (i.e., labeling and shelf life), can also be found in the above 
guidance.
FDA may determine, on a case-by-case basis, that additional data are necessary to evaluate 
whether the device is appropriate for the Safety and Performance Based Pathway. In situations 
where you determine that additional testing outside of those identified in this guidance are 
necessary to determine whether the device is appropriate for the Safety and Performance Based 
Pathway, we would encourage you to submit a Pre-Submission7 to engage in discussion with 
FDA prior to submission of the 510(k).
IV. Testing Performance Criteria 
If your device is appropriate for submission through the Safety and Performance Based Pathway, 
and you choose to use that option, we do not expect you to provide direct comparison testing 
against a legally marketed predicate device to demonstrate substantially equivalent performance 
characteristics. To ensure that the performance criteria outlined in this guidance remain 
contemporary and take into account relevant data from recent clearances, FDA recommends that 
you provide a results summary for all tests evaluated in addition to the other submission 
information (e.g., Declaration of Conformity (DoC)) recommended below for each test or 
evaluation. Consistent with FDA policy for all 510(k) submissions, for all 510(k) submissions 
under the Safety and Performance Based Pathway, FDA may request and review underlying data 
demonstrating that a new device meets the FDA-identified performance criteria and testing 
methodology, as necessary. Unless otherwise identified in the performance criteria sections 
below, test information such as summary results or test protocols should be submitted as part of 
the 510(k) as described in FDAs guidance, Safety and Performance Based Pathway.8 For 
additional information regarding the submission of non-clinical bench testing information, please 
refer to FDAs guidance: Recommended Content and Format of Non-Clinical Bench 
Performance Testing Information in Premarket Submissions.9
FDA believes that the testing and performance criteria identified in this section provide at least 
the same level of protection of the public health and safety as the testing described in the 
guidance document entitled, Premarket Notification [510(k)] Guidance Document for Class II 
Daily Wear Contact Lenses.10 To the extent the recommendations in this section depart from 
7Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-
meetings-medical-device-submissions-q-submission-program.
8Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-and-performance-
based-pathway.
9Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommended-content-
and-format-non-clinical-bench-performance-testing-information-premarket.
10Note that tests involving leachability, lens solution compatibility, and preservative uptake and release identified in 
the guidance document, Premarket Notification [510(k)] Guidance Document for Class II Daily Wear Contact 
Lenses, are mainly driven by material characteristics and properties of soft daily wear contact lenses that have been 
defined and incorporated into the testing performance criteria identified in this section.
6 Contains Nonbinding Recommendations
previously issued recommendations in the above guidance document, this section supersedes 
those previous recommendations.
Physicochemical and Optical Properties
1. Test name: Spectral Transmittance (%) 
Methodology: One of the following FDA currently-recognized consensus standards (as 
applicable):
 ISO 18369-3 Ophthalmic optics - Contact lenses - Part 3: Measurement methods
 ANSI Z80.20 American National Standard for Ophthalmics - Contact Lenses - 
Standard Terminology, Tolerances, Measurements and Physicochemical 
Properties
 We recommend measurement of the spectral transmittance with the thickest 
version of the lens to be marketed
Performance Criteria (polymacon): 93%  5%
Performance Criteria (etafilcon A): 94%  5%
Performance Criteria (hioxifilcon D): 96%  5%
Performance Criteria Source: Criteria are based on aggregated data submitted to FDA in 
510(k) submissions previously found to be substantially equivalent, and ISO 18369-2:2017 
Ophthalmic optics - Contact lenses - Part 2: Tolerances and ANSI Z80.20-2016 for 
tolerances.
Submission Information: Results summary and Declaration of Conformity (DoC)
2. Test name: Ultra Violet (UV) Transmittance (%) 
Methodology: One of the following FDA currently-recognized consensus standards (as 
applicable):
 ISO 18369-3 Ophthalmic optics - Contact lenses - Part 3: Measurement methods
 ANSI Z80.20 American National Standard for Ophthalmics - Contact Lenses - 
Standard Terminology, Tolerances, Measurements and Physicochemical 
Properties
 We recommend measurement of the UV transmittance with the thinnest version 
of the UV lens to be marketed
Performance Criteria (polymacon):   < 0.05   < 0.50 
UVB V;  UVA  V
Performance Criteria (etafilcon A):   < 0.05   < 0.50 
UVB V;  UVA  V
Performance Criteria (hioxifilcon D):   < 0.05   < 0.50 
UVB V;  UVA  V
 luminous transmittance of the contact lens,  and  are the average ultraviolet 
V =  UVB  UVA 
radiation transmittances of the contact lens, summated over the UVB (280 nm to 315 nm) 
and the UVA (316 nm to 380 nm) wavelengths respectively
Performance Criteria Source: ANSI Z80.20-2016
Additional Considerations: Only needed for materials with added UV absorbers
Submission Information: DoC and Results Summary if using ISO 18369-3 for 
methodology, otherwise DoC if using ANSI Z80.20 for the methodology
3. Test name: Refractive Index 
Methodology: One of the following FDA currently-recognized consensus standards (as 
applicable):
7 Contains Nonbinding Recommendations
 ISO 18369-4 Ophthalmic optics - Contact lenses - Part 4: Physicochemical 
properties of contact lens materials
 ANSI Z80.20 American National Standard for Ophthalmics - Contact Lenses - 
Standard Terminology, Tolerances, Measurements and Physicochemical 
Properties
Performance Criteria (polymacon): 1.437  0.005
Performance Criteria (etafilcon A): 1.402  0.005
Performance Criteria (hioxifilcon D): 1.407  0.005
Performance Criteria Source: Criteria are based on aggregated data submitted to FDA in 
510(k) submissions previously found to be substantially equivalent, and ISO 18369-2:2017 
Ophthalmic optics - Contact lenses - Part 2: Tolerances for tolerances.
Submission Information: Results summary and DoC
4. Test name: Water Content (%) 
Methodology: One of the following FDA currently-recognized consensus standards (as 
applicable):
 ISO 18369-4 Ophthalmic optics - Contact lenses - Part 4: Physicochemical 
properties of contact lens materials
 ANSI Z80.20 American National Standard for Ophthalmics - Contact Lenses - 
Standard Terminology, Tolerances, Measurements and Physicochemical 
Properties
Performance Criteria (polymacon): 38  2%
Performance Criteria (etafilcon A): 58  2%
Performance Criteria (hioxifilcon D): 54  2%
Performance Criteria Source: Criteria are based on aggregated data submitted to FDA in 
510(k) submissions previously found to be substantially equivalent and ISO 18369-2:2017 
Ophthalmic optics - Contact lenses - Part 2: Tolerances for tolerances.
Submission Information: Results summary and DoC
5. Test name: Specific Gravity 
Methodology: Any standard methodology accepted
Performance Criteria (polymacon): 1.124  0.037
Performance Criteria (etafilcon A): 1.062  0.041
Performance Criteria (hioxifilcon D): 1.214  0.094  
Performance Criteria Source: Criteria are based on aggregated data submitted to FDA in 
510(k) submissions previously found to be substantially equivalent
Submission Information: Complete test report
6. Test name: Oxygen Permeability (Dk or [cm2/s][ml O /ml x mmHg]) 
2
Methodology: One of the following FDA currently-recognized consensus standards (as 
applicable):
 ISO 18369-4 Ophthalmic optics - Contact lenses - Part 4: Physicochemical 
properties of contact lens materials
 ANSI Z80.20 American National Standard for Ophthalmics - Contact Lenses - 
Standard Terminology, Tolerances, Measurements and Physicochemical 
Properties
8 Contains Nonbinding Recommendations
Performance Criteria (polymacon): 10.76 x 10-11  20%
Performance Criteria (etafilcon A): 22.43 x 10-11  20%
Performance Criteria (hioxifilcon D): 20.84 x 10-11  20%  
Performance Criteria Source: Criteria are based on aggregated data submitted to FDA in 
510(k) submissions previously found to be substantially equivalent and ISO 18369-2:2017 
Ophthalmic optics - Contact lenses - Part 2: Tolerances for tolerances.
Submission Information: Results summary and DoC
7. Test name: Extractables (< 1% with water and hexane) 
Methodology: One of the following FDA currently-recognized consensus standards (as 
applicable):
 ISO 18369-4 Ophthalmic optics - Contact lenses - Part 4: Physicochemical 
properties of contact lens materials
 ANSI Z80.20 American National Standard for Ophthalmics - Contact Lenses - 
Standard Terminology, Tolerances, Measurements and Physicochemical 
Properties
Performance Criteria (polymacon): <1% extractables, hexane and water
Performance Criteria (etafilcon A): <1% extractables, hexane and water
Performance Criteria (hioxifilcon D): <1% extractables, hexane and water
Performance Criteria Source: Criteria are based on aggregated data submitted to FDA in 
510(k) submissions previously found to be substantially equivalent.
Submission Information: Results summary and DoC
Mechanical Properties
8. Test name: Modulus (MPa or N/mm2) 
Methodology: One of the following FDA currently-recognized consensus standards (as 
applicable):
 ASTM D882 Standard Test Methods for Tensile Properties of Thin Plastic 
Sheeting
 ANSI Z80.20 - American National Standard for Ophthalmics - Contact Lenses - 
Standard Terminology, Tolerances, Measurements and Physicochemical 
Properties
Performance Criteria (polymacon): 0.62  0.25 MPa
Performance Criteria (etafilcon A): 0.42  0.09 MPa
Performance Criteria (hioxifilcon D): 0.36  0.10 MPa 
Performance Criteria Source: Criteria are based on aggregated data submitted to FDA in 
510(k) submissions previously found to be substantially equivalent.
Submission Information: Results summary and DoC
9. Test name: Tensile Strength (MPa or N/mm2) 
Methodology: ASTM D882 Standard Test Methods for Tensile Properties of Thin 
Plastic Sheeting
Performance Criteria (polymacon): 0.63  0.11 MPa 
Performance Criteria (etafilcon A): range of 0.07 to 0.41 MPa
Performance Criteria (hioxifilcon D): 0.65  0.26 MPa
9 Contains Nonbinding Recommendations
Performance Criteria Source: Criteria are based on aggregated data submitted to FDA in 
510(k) submissions previously found to be substantially equivalent.
Submission Information: Results summary and DoC
10. Test name: Elongation at Break (%) 
Methodology: ASTM D882 Standard Test Methods for Tensile Properties of Thin 
Plastic Sheeting
Performance Criteria (polymacon): 240  108%
Performance Criteria (etafilcon A): range of 50 to 340%
Performance Criteria (hioxifilcon D): 249  69% 
Performance Criteria Source: Criteria are based on aggregated data submitted to FDA in 
510(k) submissions previously found to be substantially equivalent.
Submission Information: Results summary and DoC.
Packaging Solution
11. Test name: Packaging Solution pH 
Methodology: Any standard methodology accepted
Performance Criteria (all materials): 7.2  7.4
Performance Criteria Source: Aggregated cleared 510(k) submissions
Submission Information: Results summary
12. Test name: Packaging Solution Osmolality (osmol/kg) 
Methodology: Any standard methodology accepted
Performance Criteria (all materials): 280-320 osmol/kg
Performance Criteria Source: Aggregated cleared 510(k) submissions
Submission Information: Results summary
Sterilization 
13. Test name: Sterilization (devices labeled as sterile)  
Methodology: FDA currently-recognized version of the following consensus standards 
(as applicable):
 ISO 17665-1 Sterilization of health care products  Moist heat  Part 1: 
Requirements for the development, validation, and routine control of a 
sterilization process for medical devices
 ISO 11607-1 Packaging for terminally sterilized medical devices  Part 1: 
Requirements for materials, sterile barrier systems and packaging systems
 ISO 11607-2 Packaging for terminally sterilized medical devices  Part 2: 
Validation requirements for forming, sealing and assembly processes
Performance Criteria: Validation testing should demonstrate the cleanliness and 
sterility of the device to a sterility assurance level of 10-6. You should provide a 
description of the packaging (sterile barrier system) and how it will maintain device 
sterility, and a description of the package test methods as described in ISO 11607-2 and 
package test data.
Performance Criteria Source: FDAs guidance:
10 Contains Nonbinding Recommendations
 Submission and Review of Sterility Information in Premarket Notification 
(510(k)) Submissions for Devices Labeled as Sterile11
Additional Considerations: Please note that for devices considered in this guidance these 
recommendations pertain solely to moist heat sterilization. Any other sterilization method 
(e.g., ethylene oxide, radiation, or dry heat) is outside the scope of this guidance.
Submission Information: If using an Established Category A sterilization method, you 
should provide the information described in Section V.A. of the FDA guidance 
Submission and Review of Sterility Information in Premarket Notification (510(k) 
Submissions for Devices Labeled as Sterile; generally, the validation data itself is not 
needed to demonstrate substantial equivalence.
Biocompatibility 
To identify the biocompatibility endpoints to include as part of your biocompatibility evaluation 
you should use Attachment A of the FDA guidance Use of International Standard ISO 10993-1, 
Biological evaluation of medical devices  Part 1: Evaluation and testing within a risk 
management process,12 referred to in the rest of this document as the FDA Biocompatibility 
Guidance for brevity. FDA considers the devices covered by this guidance to be categorized as 
Surface Devices with a limited mucosal membrane contact duration of  24 hours and you 
should assess the endpoints below, as referenced in Attachment A of the CDRH Biocompatibility 
Guidance, with the following FDA currently-recognized consensus standards.
 Cytotoxicity - ISO 10993-5 Biological evaluation of medical devices  Part 5: Tests 
for in vitro cytotoxicity 
 Sensitization - ISO 10993-10 Biological evaluation of medical devices  Part 10: 
Tests for irritation and skin sensitization
 Ocular Irritation - ISO 10993-10 Biological evaluation of medical devices  Part 10: 
Tests for irritation and skin sensitization; ISO 10993-23 Biological evaluation of 
medical devices  Part 23: Tests for irritation
Rationale in Lieu of Testing: If the subject device is manufactured from the identical blank 
polymer buttons and identical packaging materials using identical manufacturing processes as a 
predicate device with the same type and duration of tissue contact, and any changes in device 
design are not expected to impact the biological response, this is typically sufficient to establish 
substantially equivalent biocompatibility.
Testing: If you determined that testing is needed to address some or all of the identified 
endpoints, FDA recommends that complete test reports for both the lens and packaging materials 
be provided for all tests performed unless a declaration of conformity without supplemental 
information can be appropriately provided, as described in Attachment E of the FDA 
Biocompatibility Guidance. Any test-specific positive, negative, and/or reagent controls should 
perform as expected, and protocol deviations should be thoroughly described and justified; 
11Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-and-review-
sterility-information-premarket-notification-510k-submissions-devices-labeled.
12Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-
standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-and. 
11 Contains Nonbinding Recommendations
however, note that certain protocol deviations may invalidate comparison to the performance 
criteria listed below resulting in the need for submission of a Traditional, Special, or Abbreviated 
510(k).
14. Test name: Biocompatibility endpoints (identified from FDA Biocompatibility 
Guidance) 
Methodology: FDA currently-recognized versions of biocompatibility consensus 
standards
Performance Criteria: All direct or indirect tissue contacting components of the device 
and device-specific instruments should be determined to have an acceptable biological 
response.
Performance Criteria Source: The FDA Biocompatibility Guidance
Additional Considerations: For any biocompatibility test samples with an adverse 
biological response, the biocompatibility evaluation should explain why the level of 
toxicity seen is acceptable. Some comparison testing against a legally marketed predicate 
may be necessary (and is considered acceptable under the Safety and Performance Based 
Pathway) to support such a rationale as explained in the FDA Biocompatibility Guidance. 
For standard biocompatibility methods that include comparison device control samples, 
the legally marketed comparison device control samples should perform as expected, as 
specified above for the subject device samples.  
Submission Information: Refer to FDA Biocompatibility Guidance 
12