Contains Nonbinding Recommendations
Surgical Sutures  Performance 
Criteria for Safety and Performance 
Based Pathway
______________________________________________________________________________
Guidance for Industry and
Food and Drug Administration Staff
GUIDANCE
Document issued on April 11, 2022.
For questions about this document, contact the DHT4B: Division of Infection Control and Plastic 
and Reconstructive Surgery at 301-796-6891.
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-2022-D-0552. 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 include the document 
number 20002 and complete title of the guidance in the request.
2 Contains Nonbinding Recommendations
Surgical Sutures  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 surgical sutures 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 surgical sutures will have the option 
to use the performance criteria provided 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 titled Appropriate Use of Voluntary Consensus Standards in Premarket Submissions 
for Medical Devices.3  
This guidance is being implemented without prior public comment because the Agency has 
determined that prior public participation is not feasible or appropriate (section 701(h)(1)(C)(i) 
of the FD&C Act and 21 CFR 10.115(g)(2)). FDA has determined that this guidance document 
presents a less burdensome policy that is consistent with public health. This guidance document 
1 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-and-performance-
based-pathway 
2 Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm 
3 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-
voluntary-consensus-standards-premarket-submissions-medical-devices 
3 Contains Nonbinding Recommendations
is being implemented immediately, but it remains subject to comment in accordance with the 
Agencys good guidance practices.
The contents of this document do not have the force and effect of law and are not meant to bind 
the public in any way, unless specifically incorporated into a contract. This document is intended 
only to provide clarity to the public regarding existing requirements under the law. FDA 
guidance documents, including this guidance, 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 
surgical sutures to determine the performance criteria and associated testing methods that could 
support a finding of substantial equivalence for surgical sutures 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 surgical sutures that are the subject of this guidance are absorbable and nonabsorbable 
sutures under the following regulations and product codes outlined in Table 1. These devices are 
Class II and are intended for the approximation and/or ligation of soft tissue.
4 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-and-performance-
based-pathway 
4 Contains Nonbinding Recommendations
Table 1: Surgical Sutures That Are the Subject of This Guidance
Regulation Name Regulation Product Code
Absorbable Polydioxanone Surgical (PDS) Suture 21 CFR 878.4840 NEW
Absorbable Poly(glycolide/L-lactide) Surgical Suture 21 CFR 878.4493 GAM
Nonabsorbable Poly(Ethylene Terephthalate) Surgical 
21 CFR 878.5000 GAT
Suture
Nonabsorbable Polypropylene Surgical Suture 21 CFR 878.5010 GAW, MXW
Nonabsorbable Polyamide Surgical Suture 21 CFR 878.5020 GAR
Natural Nonabsorbable Silk Surgical Suture 21 CFR 878.5030 GAP
Stainless Steel Suture 21 CFR 878.4495 GAQ, NJU
Nonabsorbable Expanded Polytetrafluoroethylene 
21 CFR 878.5035 NBY
(ePTFE) Surgical Suture
The following types of surgical sutures are outside the scope of this guidance:
 Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA 
technology (21 CFR 878.4494, NWJ)
 Nonabsorbable expanded polytetrafluoroethylene surgical suture for chordae tendinae 
repair or replacement (21 CFR 878.5035, PAW)
 Absorbable surgical gut suture (21 CFR 878.4830, GAL)
Intended Use/Indications for Use:
The surgical sutures that fall within the scope of this guidance document are intended for general 
soft tissue approximation and/or ligation, such as use in ophthalmic, cardiovascular, 
neurological, orthopedic, and dental procedures. For example, stainless steel sutures indicated for 
soft tissue approximation, abdominal wound closure, hernia repair, sternal closure and certain 
orthopedic procedures, including cerclage and tendon repair, would be within the scope of this 
guidance.
Surgical sutures that fall outside the scope of this guidance document include those intended for 
more specific uses than those identified in the regulations in Table 1 above (e.g., sutures intended 
for aesthetic uses or specialized cardiovascular applications).
Device Design and Other Characteristics:
Non-absorbable sutures are described as a multifilament or monofilament, non-absorbable, 
sterile, flexible, metallic, natural or polymeric thread intended for uses such as soft tissue 
approximation and ligation, abdominal wound closure, intestinal anastomosis, hernia repair, and 
sternal closure. It may be coated or uncoated, undyed or dyed with an approved color additive,5
and provided with or without an attached needle(s).  
5 See Summary of Color Additives for Use in the United States in Foods, Drugs, Cosmetics, and Medical Devices 
at https://www.fda.gov/industry/color-additive-inventories/summary-color-additives-use-united-states-foods-drugs-
cosmetics-and-medical-devices for more information
5 Contains Nonbinding Recommendations
Absorbable sutures are described as a multifilament or monofilament, absorbable, sterile, 
flexible, synthetic thread intended for soft tissue approximation and ligation. It may be coated or 
uncoated, undyed or dyed with an approved color additive, and provided with or without an 
attached needle(s).  
Surgical sutures within the scope of this guidance must meet the requirements of 21 CFR 70.5(c) 
regarding the use of color additives in sutures. 
Surgical sutures with the following types of characteristics are outside the scope of this guidance:
 Sutures comprised of materials other than those listed in Table 1.
 Sutures comprised of animal-derived materials. 
 Sutures that contain a drug or biologic.
 Sutures with atypical design features, including barbs, loops, anchors, knots, unique 
braiding patterns (e.g., suture tapes, braids containing an expandable core), sutures 
supplied with specialized delivery tools, including hollow needles or cannulas (i.e., non-
swaged needles), and other design features that would necessitate performance evaluation 
outside the scope of this guidance.
 Surgical sutures that contain a color additive not already approved for use in the specific 
suture material. 
 Sutures sterilized using novel sterilization methods as described in FDAs guidance 
Submission and Review of Sterility Information in Premarket Notification (510(k)) 
Submissions for Devices Labeled as Sterile.6
Some of the recommendations in this safety and performance guidance may assist in complying 
with some of the special controls for surgical sutures. For information regarding the special 
controls for surgical sutures, see Surgical Sutures - Class II Special Controls Guidance 
Document for Industry and FDA Staff.7
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-Submission8 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 
6 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-and-review-
sterility-information-premarket-notification-510k-submissions-devices-labeled 
7 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/class-ii-special-controls-
guidance-document-surgical-sutures-guidance-industry-and-fda-staff 
8 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/requests-feedback-and-
meetings-medical-device-submissions-q-submission-program 
6 Contains Nonbinding Recommendations
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 below. 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. We recommend that all surgical sutures conform to the 
monographs and sections of the currently FDA-recognized edition of the USP, as identified 
below. Additionally, we recommend that you conduct all testing on the sterilized suture in 
finished form (e.g., needled, in reels) as per the Monograph for Nonabsorbable Sutures or as per 
the Monograph for Absorbable Sutures. Unless otherwise identified in the sections below, test 
information such as results summary, test protocols, and complete test reports should be 
submitted as part of the 510(k) as described in FDAs guidance Safety and Performance Based 
Pathway. For additional information regarding the submission of non-clinical bench testing 
information, refer to FDAs guidance Recommended Content and Format of Non-Clinical Bench 
Performance Testing Information in Premarket Submissions.9
1.  Test name: Absorbable Suture Diameter (only for absorbable surgical sutures)
Methodology: FDA-recognized version of USP 43-NF38 <861> Sutures  Diameter
Performance Criteria: The average diameter, and no less than 20 of the 30 
measurements on the 10-strand sample, are within the limits on average in Table 2 of 
USP 43-NF38 (2020) Absorbable Surgical Suture for synthetic sutures within the 
absorbable suture monograph for the size stated on the label. None of the individual 
observed measurements should be less than or greater than the limits on individual 
diameters in Table 2 of USP 43-NF38 (2020) Absorbable Surgical Suture.
Performance Criteria Source: FDA-recognized version of USP 43-NF38 (2020) 
Absorbable Surgical Suture
Sutures That Do Not Meet the Performance Criteria:  If your suture does not meet 
USP requirements for diameter (e.g., oversize in diameter), it may still be appropriate for 
the Safety and Performance Based Pathway provided that the suture diameter is not 
oversized by more than 1 USP size (i.e., the maximum diameter for a given size is not 
more than the maximum individual limit on diameter for the next larger size). The 
labeling should clearly state that the suture is non-USP and should identify, for each 
suture size, the maximum oversize in diameter. This information can be presented as a 
table that identifies the USP size, associated USP diameter range, and maximum oversize 
for each proposed size.  
Submission Information: Results summary and DoC
2.  Test name: Nonabsorbable Suture Diameter (only for nonabsorbable surgical sutures)
Methodology: FDA-recognized version of USP 43-NF38 <861> Sutures  Diameter
9 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommended-content-
and-format-non-clinical-bench-performance-testing-information-premarket 
7 Contains Nonbinding Recommendations
Performance Criteria: The average diameter, and no less than 20 of the 30 
measurements on the 10-strand sample, are within the limits on average in Table 1 of 
USP 43-NF38 (2020) Nonabsorbable Surgical Suture for the size stated on the label. 
None of the individual observed measurements should be less than or greater than the 
limits on individual diameters in Table 1 of USP 43-NF38 (2020) Nonabsorbable 
Surgical Suture.
Performance Criteria Source: FDA-recognized version of USP 43-NF38 (2020) 
Nonabsorbable Surgical Suture 
Sutures That Do Not Meet the Performance Criteria: If your suture does not meet 
USP requirements for diameter (e.g., oversize in diameter), it may still be appropriate for 
the Safety and Performance Based Pathway provided that the suture diameter is not 
oversized by more than 1 USP size (i.e., the maximum diameter for a given size is not 
more than the maximum individual limit on diameter for the next larger size). The 
labeling should clearly state that the suture is non-USP and should identify, for each 
suture size, the maximum oversize in diameter. This information can be presented as a 
table that identifies the USP size, associated limits on average diameter, and maximum 
oversize for each proposed size. 
Submission Information: Results summary and DoC
3.  Test name: Needle Attachment
Methodology: FDA-recognized version of USP 43-NF38 <871> Sutures  Needle 
Attachment
Performance Criteria: Neither the average of the 5 values nor any individual value is 
less than the limits given for the designated size in Table 1 of USP 43-NF38 <871> 
Sutures  Needle Attachment.
Performance Criteria Source: FDA-recognized version of USP 43-NF38 (2020) <871> 
Sutures  Needle Attachment
Submission Information: Results summary and DoC
4.  Test name: Absorbable Suture Tensile Strength (only for absorbable surgical sutures)
Methodology: FDA-recognized version of USP 43-NF38 <881> Sutures  Tensile 
Strength
Performance Criteria: The average tensile strength is no less than that set forth in Table 
2 of USP 43-NF38 (2020) Absorbable Surgical Suture for synthetic sutures within the 
absorbable suture monograph for the class and the size stated on the label.
Performance Criteria Source: FDA-recognized version of USP 43-NF38 (2020) 
Absorbable Surgical Suture
Submission Information: Results summary and DoC
5.  Test name: Nonabsorbable Suture Tensile Strength (only for nonabsorbable surgical 
sutures)
Methodology: FDA-recognized version of USP 43-NF38 <881> Sutures  Tensile 
Strength
Performance Criteria: The average tensile strength is no less than that set forth in Table 
1 of USP 43-NF38 (2020) Nonabsorbable Surgical Suture for the class and the size stated 
on the label.
8 Contains Nonbinding Recommendations
Performance Criteria Source: FDA-recognized version of USP 43-NF38 (2020) 
Nonabsorbable Surgical Suture
Submission Information: Results summary and DoC
6.  Test name: Resorption Profile (only for absorbable surgical sutures)
Methodology: The resorption profile testing should include information to document the 
devices rate of absorption, time to complete absorption, and residual tensile strength 
over time. The resorption profile should be presented in a chart, table, or graph that 
illustrates the residual tensile strength of the suture for a clinically significant period of 
time. The length of time considered clinically significant depends on the sutures 
intended use. We recommend that studies be performed in vivo using a model that 
appropriately replicates how and where the surgical suture is intended to be used. A 
significant number of sutures should be tested to demonstrate consistent tensile strength 
retention of the surgical suture. Additionally, testing should include at least the largest 
and smallest sizes of your suture, as well as sizes in between, skipping no more than two 
size differences between sizes tested. For example, if you intend to market all suture sizes 
from 7 to 7-0, we recommend that you test the sizes 7, 4, 1, 2-0, 5-0, and 7-0 for tensile 
strength retention. For additional information, see the special controls document 
Surgical Sutures  Class II Special Controls Guidance for Industry and FDA Staff.
Performance Criteria: The device has a resorption profile that is consistent with the 
intended use of the device (e.g., short-term or long-term approximation of soft tissue). 
Performance Criteria Source: Surgical Sutures  Class II Special Controls Guidance 
for Industry and FDA Staff 
Submission Information: Results summary and testing protocol
7.  Test name: Sterilization (for devices labeled as sterile) 
Methodology: Current FDA-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 11135-1 Sterilization of health care products  Ethylene oxide  Part 1: 
Requirements for development, validation, and routine control of a sterilization 
process for medical devices
 ISO 11137-1 Sterilization of health care productsRadiationPart 1: 
Requirements for development, validation, and routine control of a sterilization 
process for medical devices
 ISO 20857 Sterilization of health care products  Dry heat  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 sterility of, or the 
ability to sterilize to a sterility assurance level of 10-6 for, the device. 
9 Contains Nonbinding Recommendations
Performance Criteria Source: FDAs guidance:
  Submission and Review of Sterility Information in Premarket Notification 
(510(k)) Submissions for Devices Labeled as Sterile10
Submission Information: You should provide a description of the packaging (sterile 
barrier system) and how it will maintain the devices sterility, and a description of the 
package test methods, but not package test data. With respect to the Established 
Sterilization Method, whether using an Established Category A or Established Category 
B sterilization method, you should provide the information 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. 
8.  Test name: Shelf Life
Methodology: Shelf life studies should evaluate the critical device properties to ensure 
the device will perform adequately and consistently during the entire proposed shelf life. 
You should follow performance testing methods outlined in Tests #1-7 above (as 
applicable) using aged versions of the suture. Testing should be performed on at least 
three (3) production lots of devices aged according to the proposed shelf life.
Performance Criteria: To demonstrate continued sterility, package integrity, and device 
functionality over the labeled shelf life, the aged versions of the suture should meet the 
respective performance criteria outlined in Tests #1-7 above (as applicable).
Performance Criteria Source: See performance criteria sources for Tests #1-7 above. 
Additional Considerations: If you use devices subject to accelerated aging for shelf life 
testing, we recommend that you specify the way in which the devices were aged. We 
recommend that you age your devices as per the current FDA-recognized version of 
ASTM F1980 Standard Guide for Accelerated Aging of Sterile Barrier Systems for 
Medical Devices and specify the environmental parameters established to attain the 
expiration date. For sutures containing polymeric materials, you should plan to conduct 
testing on real-time aged samples to confirm that the accelerated aging is reflective of 
real-time aging. 
Submission Information: See Submission Information sections for Tests #1-7 above. 
We recommend that you provide a summary of the test methods used for your shelf life 
testing, results and the conclusions drawn from your results.
Biocompatibility Evaluation
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,11 referred to in the rest of this document as the FDA Biocompatibility 
Guidance for brevity. The contact type and duration for surgical sutures will depend on the 
10 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submission-and-review-
sterility-information-premarket-notification-510k-submissions-devices-labeled 
11 Available 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 
10 Contains Nonbinding Recommendations
intended use. FDA considers surgical sutures to be implant devices in contact with tissue/bone, 
as well as blood in some cases, for a prolonged or permanent contact duration, as described in 
ISO 10993-1 and Attachment A of the FDA Biocompatibility Guidance. For a prolonged or 
permanent contact duration suture in contact with tissue/bone, the following endpoints should be 
addressed in your biocompatibility evaluation.
 Cytotoxicity
 Sensitization
 Irritation or Intracutaneous Reactivity
 Acute systemic toxicity
 Material-Mediated Pyrogenicity
 Subacute/Subchronic Toxicity
 Genotoxicity
 Clinically-relevant implantation
 Chronic Toxicity
 Carcinogenicity
Additional endpoints for prolonged or permanent contact duration sutures in contact with blood 
include:
  Hemocompatibility
Rationale in Lieu of Testing: If the subject device is manufactured from the identical raw 
materials using identical manufacturing processes as a predicate device with the same type and 
duration of tissue contact, and any changes in geometry are not expected to impact the biological 
response, this is typically sufficient to establish substantially equivalent biocompatibility, if 
documentation such as that outlined in Attachment F of the FDA Biocompatibility Guidance is 
also provided.
Testing: If you determined that testing is needed to address some or all of the identified 
endpoints, FDA recommends that complete test reports be provided for all tests performed unless 
a declaration of conformity without supplemental information can be appropriately provided, as 
discussed 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; however, note that certain protocol deviations may invalidate 
comparison to the performance criteria listed below.  As described in the FDA guidance, Safety 
and Performance Based Pathway,12 if a device cannot rely entirely on performance criteria 
identified by FDA to demonstrate substantial equivalence for its submission, it is not appropriate 
for the Safety and Performance Based Pathway program; however, the previously established 
510(k) programs in which direct performance comparisons against appropriate predicates are 
conducted, including Traditional, Special, and Abbreviated 510(k)s, remain available.
9.  Test name: Biocompatibility endpoints (identified from FDA Biocompatibility 
Guidance)
12 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-and-
performance-based-pathway 
11 Contains Nonbinding Recommendations
Methodology: Current FDA-recognized versions of biocompatibility consensus 
standards
Performance Criteria: All direct tissue contacting components of the device 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 appropriate under the Safety and Performance Based 
Pathway) to support such a rationale as explained in the FDA Biocompatibility Guidance. 
For standard biocompatibility test methods that include comparison device control 
samples, the legally marketed comparison device control samples should perform as 
expected.
For surgical sutures supplied with needles, you should cite conformance to an FDA-
recognized standard (e.g., for stainless steel) and provide a justification for why 
biocompatibility testing is not needed for the needle.  If you are unable to cite 
conformance to a recognized standard and/or if your needle is coated, biocompatibility 
testing should be conducted on the needle component in accordance with ISO 10993-1 
for the appropriate contact classification  e.g., external communicating device with 
limited contact duration (< 24 hours). 
Submission Information: Refer to FDA Biocompatibility Guidance
12