Guidance for Industry and FDA Staff  
 
Medical Devices with Sharps 
Injury Prevention Features
  
 
 
 
Document Issued on: August 9, 2005  

 
This document supersedes Supplementary Guidance on the Content of 
Premarket Notification [510(k)] Submissions for Medical Devices with 

Sharps Injury Prevention Features (Antistick), 12/31/2002 
  
 
For questions regarding this document, please contact Mr. Anthony Watson at 240-276-3700. 
 
 
 
U.S. Department of Health and Human Services  
Food and Drug Administration  
Center for Devices and Radiological Health  
   
General Hospital Devices Branch  
Division of Anesthesiology, General Hospital,  
Infection Control, and Dental Devices  
Office of Device Evaluation   Contains Nonbinding Recommendations  
 
 
 
Preface 
 
Public Comment  
Written comments and suggestions may be submitted at any time for Agency consideration to 
the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, 
Room 1061, (HFA-305), Rockville, MD, 20852.  When submitting comments, please refer to 
the exact title of this guidance document.  Comments may not be acted upon by the Agency 
until the document is next revised or updated.   
 
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Additional copies are available from the Internet at: 

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  Contains Nonbinding Recommendations  
 
 
Table of Contents 
 
 
1.  Introduction.............................................................................................................. 1 
2.  Background .............................................................................................................. 2
  
3.  The Content and Format of an Abbreviated 510(k) Submission ........................ 3
  
4.  Scope .......................................................................................................................... 5
  
5.  Design Controls ........................................................................................................ 6
  
6.  Device Description.................................................................................................... 7
  
7.  Risks to Health ......................................................................................................... 8
  
8.  Bench Testing ........................................................................................................... 9
  
9.  Microbial Ingress Tests ......................................................................................... 10
  
10.      Simulated Clinical Use Testing ............................................................................. 10
  
11.      Sterilization............................................................................................................. 14 
12.  Biocompatibility ..................................................................................................... 14
  
13.  Labeling ................................................................................................................... 15
  
Appendix I.  Abbreviations .............................................................................................. 17
  
 
  Contains Nonbinding Recommendations  
 
Guidance for Industry and FDA Staff  
 
Medical Devices with Sharps Injury 
Prevention Features
  
 
This guidance represents the Food and Drug Administration's (FDA's) current thinking 
on this topic. It does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. You can use an alternative approach if the approach 
satisfies the requirements of the applicable statutes and regulations.  If you want to discuss 
an alternative approach, contact the FDA staff responsible for implementing this 
guidance. If you cannot identify the appropriate FDA staff, call the appropriate number 
list ed on the title page of this guidance.  
 
 
1.  Introduction 
FDA has developed this guidance document to assist industry in preparing  premarket  
notification submissions for medical devices that incorporate a sharps injury prevention 
feature (e.g., anti-needlestick feature).  A sharps injury prevention feature is designed to 
protect the user from a sharps injury.  Most medical devices that include sharps injury 
prevention features are either intravascular (IV) administration sets (21 CFR 880.5440), 
piston syringes (21 CFR 880.5860), or hypodermic single lumen needles (21 CFR 880.5570).   
 
This guidance pertains only to the sharps injury prevention feature.  It does not provide 
FDAs recommendations for the device itself.  Therefore, you should also consult FDA 
guidance, if available, for the device, as in the examples below.  
 
  Guidance on the Content of Premarket Notification 510(k) Submissions for 
Hypodermic Single Lumen Needles, http://www.fda.gov/cdrh/ode/odegr450.html 
 
  Guidance on Intravascular Administrations Sets Premarket Notification 
Submissions [510K)]  https://www.fda.gov/downloads/MedicalDevices/ 
  DeviceRegulationandGuidance/GuidanceDocuments/ucm070850.pdf
 
 Guidance On Th e Content Of Premarket Notification [510(K ) ] S ubmissions for 
  Piston Syringes http://www.fda.gov/cdrh/ode/odegr821.html 
Some sharps injury prevention features are incorporated as integrated components of finished 
devices.  Others are marketed separately as accessories that are attached to a device by the 
user at the point of use, for example, a needle shield,  marketed  separate ly,  which the user 
  1   Contains Nonbinding Recommendations  
 
attache s to a piston syringe before use.  This guidance applies to both integrated sharps injury 
prevention features and accessories marketed separately.  
 
The Least Burdensome Approach  
The issues identified in this guidance document represent those that we believe should be 
addressed before your device can be marketed.  In developing the guidance, we carefully 
considered the relevant statutory criteria for Agency decision-making.  We also 
considered the burden that may be incurred in your attempt to follow the guidance and 
address the issues we have identified.  We believe that we have considered the least 
burdensome approach to resolving the issues presented in the guidance document.  If, 
however, you believe that there is a less burdensome way to address the issues, you 
should follow the procedures outlined in the A Suggested Approach to Resolving Least 
Burdensome Issues document.  It is available on our Centers Web page at https://
www.fda.gov/downloads/MedicalDevices/DeviceRegul ationandGuidance/
  GuidanceDocuments/UCM588914.pdf. 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agency's current thinking on a topic and 
should be viewed only as recommendations, unless specific regulatory or sta tutory 
requirements are cited. The use of the word should in Agency guidances means that 
something is suggested or recommended, but not required.  
 
2.  Background 
A manufacturer who intends to market a device of this generic type should conform to 
the general controls of the Federal Food, Drug, and Cosmetic Act (the Act), including the 
premarket notification requirements described in 21 CFR 807 Subpart E, and obtain a 
substantial eq uivalence determination from FDA prior to marketing the device.  (See also 
21 CFR 807.81 and 807.87 ).   
 
This document supplements other FDA documents regarding the specific content 
requirements of a premarket notification submission.  You should also refer to 21 CFR 
807.87 and "How to Prepare a 510(k) Submission" on FDA Device Advice at 
http://www.fda.gov/cdrh/devadvice/314.html.  
 
Under The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial 
Equivalence in Premarket Notifications , http://www.fda.gov/cdrh/ode/parad510.html, a 
manufacturer may submit a Traditional 510(k) or has the option of submitting either an 
Abbreviated 510(k) or a Special 510(k).  FDA believes an Abbreviated 510(k) provides the 
least burdensome means of demonstrating substantial equivalence for a new device, 
particularly once FDA has issued a guidance document addressing that device.  
Manufacturers considering certain modifications to their own cleared devices may lessen the 
regulatory burden by submitting a Special 510(k).  
  2   Contains Nonbinding Recommendations  
 
 
3.  The Content and Format of an Abbreviated 510(k)
Submission 
An Abbreviated 510(k) submission must include the required elements identified in 21  CFR 
807.87, including the proposed labeling for the device sufficient to describe the device, its 
intended use, and the directions for its use.  In an Abbreviated 510(k), FDA may cons ider the 
contents of a summary report to be appropriate supporting data within the meaning of 21 
CFR 807.87(f) or (g); therefore, we recommend that you include a summary report.  The 
report should describe how this guidance document was used during the device development 
and testing and should briefly describe the methods or tests used.  We recommend that you 
also include a summary of the test data or description of the acceptance criteria applied to 
address the risks identified in this document, as well as any additional risks specific to your 
device.  This section suggests information to fulfill some of the requirements of 21 CFR 
807.87, as well as some other items that we recommend you include in an Abbreviated 
510(k).  
 
Coversheet  
The coversheet should prominently identify the submission as an Abbreviated 510(k) 
and cite the title of this guidance document.  
 
Proposed labeling  
Proposed labeling should be sufficient to describe the device, its intended use, and the 
directions for its use.  (Refer to Section 11 for specific information that we recommend 
you include in labeling.)  
 
Summary report  
We recommend that the summary report contain:  
 
Description of the device and its intended use    
We recommend that you describe the performance specifications and, when 
appropriate, include detailed, labeled drawings of the device.  (Please refer to 
Section 5.   Device Description for specific information that we recommend you 
include in the device description for devices of the types covered by this guidance 
document.)  You should also submit an "indications for use" enclosure. 1   
 
                                                 
1 Refer to  http://www.fda.gov/cdrh/ode/indicate.html for the recommended format.  
 
  3   Contains Nonbinding Recommendations  
 
Description of device design  
We recommend that you include a brief description of the device design 
requirements.  
 
Identification of the risk analysis method  
We recommend that you identify the risk analysis method(s)  you used to assess the 
risk profile, in general, as well as the specific devices design and the results of this 
analysis. (Please refer to Section 6.  Risks to Health for the risks to health 
generally associated with the use of t his device that FDA has identified.)  
 
Discussion of the device characteristics  
We recommend that you discuss the device characteristics that address the risks 
identified in this guidance document, as well as any additional risks identified in 
your risk ana lysis.  
 
Description of the performance aspects  
We recommend that you include a brief description of the test method(s) you have  
used or intend to use to address each performance aspect identified in Sections 7-11  
of this guidance document .  If you follow a suggested test method, you may cite the 
method rather than describing it.  If you modify a suggested test method, you may 
cite the method but should provide sufficient information to explain the nature of 
and reason for the modification.  For each test, you may either (1) briefly present 
the data resulting from the test in clear and concise form, such as a table, or (2) 
describe the acceptance criteria that you will apply to your test results.2  (See also 
21 CFR 820.30, Subpart C - Design Controls under the Quality System Regulation.)  
 
Reliance on standards  
If you choose to rely on a recognized standard for any part of the device design or 
testing, you may include either a:  
 
  statement that testing will be conducted and meet specified acceptance
criteria be fore the device  is marketed, or 
 
                                                 
2 If FDA makes a substantial equivalence determination based on acceptance criteria, the 
subject device should be tested and shown to meet these acceptance criteria before being 
introduced into interstate commerce.  If the finished device does not meet the accep tance 
criteria and , thus, differs from the device described in the cleared 510(k), FDA recommends 
that submitters apply the same criteria used to assess modifications to legally marketed 
devices (21 CFR 807.81(a)(3)) to determine whether marketing of the finished device 
requires clearance of a new 510(k).  
 
  4   Contains Nonbinding Recommendations  
 
  declaration of conformity to the standard.3   
 
Because a declaration of conformity is based on results from testing, we believe you 
cannot properly submit a declaration of conformity until you have completed the 
testing the standard describes.  For more information, please refer to section 
514(c)(1)(B)of the Act and the FDA guidance,  Use of Standards in Substantial 
Equivalence Determinations; Final Guidance for Industry and FDA, 
http://www.fda.gov/cdrh/ode/guidance/1131.html.  
 
If it is not clear how you have addressed the risks identified by FDA or additional risks identified 
through your risk analysis, we may request additional information about aspects of the devices 
performance characteristics.  We may also request additional information if we need it to assess the 
adequacy of your acceptance criteria.  (Under 21 CFR 807.87(l), we may request any additional 
information that is necessary to reach a determination regarding substantial equivalence.)  
 
As an alternative to submitting an Abbreviated 510(k), you can submit a Traditional 510(k) that 
provides all of the information and data required under 21 CFR 807.87 and described in this 
guidance.  A Traditional 510(k) should include all of your methods, data, acceptance criteria, and 
conclusions. Manufacturers considering certain modifications to their own cleared devices should 
consider submitting Special 510(k)s.  
 
4.  Scope 
The scope of this document is limited to medical devices  that contain a sharps injury 
prevention feature.  A medical device with a sharps injury prevention feature is a device 
designed with a component or attachment, either active or passive, that protects the user from 
a sharps injury.  
 
This document does not address sharps containers or needle recapping devices.  There is a 
separate FDA guidance document for sharps containers and needle destruction devices 
entitled Guidance on the Content and Format of Premarket Notification [510(k)] 
Submissions for Sharps Containers ,  http://www.fda.gov/cdrh/ode/895.pdf.   
 
                                                 
3 See Required Elements for a Declaration of Conformity to a Recognized Standard  
(Screening Checklist for All Premarket Notification [510(K)] Submissions), 
http://www.fda.gov/cdrh/ode/reqrecstand.html.  
 
 
 
  5 
  Contains Nonbinding Recommendations  
 
5.  Device Design 
Typically, devices with sharps injury prevention features are class II devices, subject to 21 
CFR Part 820 Quality System Regulation, which include Design Controls.  Design controls 
(21 CFR 820.30) are an interrelated set of practices and procedures that are incorporated into 
the design and development process, i.e., a system of checks and balances.  Design controls 
make systematic assessment of the design an integral part of a devices development.  As a 
result, deficiencies in design input requirements, and discrepancies between the proposed 
designs and requirements, may be discovered and corrected earlier in the development 
process.  We believe design controls increase the likelihood that the design transferred to 
production will translate into a device that is appropriate for its intended use.   
 
The design recommendations in Table 1 below are related to function and human factors 
engineering and are intended to help you address user needs for a device or feature intended 
to prevent sharps injuries.  
 
Table 1.  Design  Recommendations for Sharps Injury Prevention Features  
Type of Feature   Recommendation  
The user should be able to easily tell whether the 
All  
sharps injury prevention feature is activated.  
Once activated, t he sharps injury prevention feature 
All   cannot be deactivated and should remain protective 
through disposal.  
It should be possible to activate the feature with a 
Active (i.e., feature requires 
single-handed technique, allowing the users hands to 
activation by the user)  
remain behind the exposed sharp.  
The shield should completely enclose the needle and 
Needle S hield  
prevent finger access when activated.  
The sharp should be fully retracted within the housing 
Retractable S harp  
of the device.  
The housing  should extend beyond, i.e., fully cover 
Fixed Recessed Needle  
the sharp and prevent finger access.  
The use of color should achieve a specific purpose, 
(e.g., differentiate device models or sizes) and 
Colored Feature or Component  
conform with user conventions, (e.g., orange hubs and 
needle covers for insulin syringes).  
  6   Contains Nonbinding Recommendations  
 
 
For more information about device design and human factors, see the guidance entitled, 
Do It By Design - An Introduction to Human Factors in Medical Devices, 
and ANSI/AAMI HE48-1993: Human factors engineering guidelines and preferred 
practices for the design of medical devices.   
 
6.  Device Description 
We recommend that you identify the  device with a sharps injury prevention feature by 
regulation and product code.  We also recommend that you provide information to show how 
the sharps injury prevention featur e is similar to and different from other legally marketed 
devices by comparing:  
  indications for use 
  design features; e.g., materials, configurations, size 
  specifications and dimensions 
  materials, including chemical formulation 
  any relevant voluntary standards. 
 
We recommend that you include a s ide-by-side comparison of the information described 
below, whenever possible, in tabular format.  We also recommend that you describe how any 
differences may affect the comparative safety and performance of the sharps injury 
prevention feature.  
 
Material Composition  
We recommend that you provide a complete listing of all device materials (trade name 
and chemical formula) used in fabricating the s harps injury prevention feature, and 
identify any metallic components.  Me tallic components may affect the safety of the 
device in an MRI environment.  We also recommend that you identify any PVC 
plasticizers, bonding agents, or other additives (e.g., color additives,  ink, dyes, markings, 
radiopaque materials) and provide their amounts.   
 
It is helpful to present the information in the form of a listing, noting the component 
name followed by specific material identifier.  We believe generic class alone (e.g., 
polyvinylchloride [PVC]) is not adequate because there are many formulations of 
material compositions.   
 
Physical Specifications  
When describing physical specifications, we recommend that you explain how the 
specifications below compare to unprotected hypodermic needles or deactivated sharps 
injury preventions features.  We recommend that you indicate:   
  7   Contains Nonbinding Recommendations  
 
  dimensions such as inner diameter (ID), outer diameter (OD), height, length, width,
thickness, gauge 
  diameter of housing (for fixed recessed needle safety devices) 
  cannula/needle tip configurations 
  priming volume 
  residual volume in injection access port or syringe 
  connector type: e.g., Luer lock, slip fit, 
  dimensions of other features  
  the color of all components 
  opacity of any components that could affect use (e.g., visualization of flashback or entry
of needle into skin)  
  markings and scales: color, type of scales, indicating whether they can be read under all
conditions of use (e.g., when a needle shield is retracted before use when filling a
syringe, inverted) 
  any other unique physical features and specifications of the device. 
 
Mechanical Specifications  
When providing mechanical specifications, we recommend that you indicate the :  
  strength of materials (tensile, flexural, elongation, etc.) 
  strength of joints, bonds, connections, hinges, valves, locking mechanisms, etc. 
  rigid ity of safety shield or sheath  
  puncture/reseal limits of septa. 
 
Design Features  
We recommend that you describe any similarities or differences between the features of your 
device and similar legally marketed device of the same type, which may affect safe ty and 
effectiveness. For example, we recommend that you compare a new syringe with a safety shield 
to a legally  marketed syringe with a safety shield.  
 
7.  Risks to Health 
In the table below, FDA has identified the risks to health generally associated with t he use of sharps 
injury prevention features addressed in this document.  The information we recommend you include 
in your 510(k) to address these identified risks are given in this guidance document, as shown in the 
table below.  We recommend that you cond uct a risk analysis (before submitting your 510(k)) to 
identify any other risks specific to your device.  The 510(k) should describe the risk analysis method  
and include the risk analysis and its results.  If you elect to use an alternative approach to address a 
  8 
  Contains Nonbinding Recommendations  
 
particular risk identified in this document or have identified risks additional to those in this 
document, you should provide sufficient detail to support the approach you have used to address that 
risk.  
 
Identified risk   Recommended mitigation measures  
Device malfunction   Section 8.  Bench Testing  
Adverse tissue reaction   Section 11.  Biocompatibility  
Sectio n 9.  Microbial Ingress Testing  
Infection   Section 10.  Simulated Clinical Studies  
Section 12.  Sterilization  
Improper use   Section 13.  Labeling  
 
8.  Bench Testing 
We recommend that you conduct all testing under both a dry test condition and a wet environment 
simulating body fluids or fluids being administered.  We recommend that you evaluate your device 
compared with a similar legally marketed device, using worst case simulated static and dynamic 
forces to the failure point of the component.  We also recommend that you describe how you 
determined the worst case conditions used.  We recommend your testing assess the :  
 
  force to attach and detach connections 
 
  fo rce to activate and deactivate the safety feature (s) 
 
  reaction force generated by the activation mechanism, if any (e.g., with a passive
spring loaded feature, or an elastic component) 
 
  number of activations to failure 
 
  puncture resistance of shie ld or sheath, i.e., the force to failure (puncture) 
 
  rate of fluid flow simulating extremes of pressure (e.g., the maximum force applied to
the piston or maximum flow through an access port)  
 
  accuracy of the dose administrated, if your device has atypical or unusual markings,
e.g., inverted syringe markings . 
 
  strength of joints, bonds, connections, hinges, valves, locking mechanisms, etc.  
 
In addition to the above, we recommend you assess the tensile, flexural, and elongation  
strength of the materials.  We also recommend you state the specifications and tolerances  
related to strength, pass/fail test ing criteria, and the basis for the specification and criteria.  
 
  9 
  Contains Nonbinding Recommendations  
 
Where appropriate to your devices intended use or design, we also recommend that you 
follow ISO 594, Conical Fittings with a 6% (Luer) Taper for Syringes, Needles, and Certain 
Other Equipment  or equivalent measures in addition  to the testing already described.  
 
9.  Microbial Ingress Tests 
We recommend that you conduct microbial ingress testing of sharps injury prevention 
features that are needleless (i.e., needle-free). 4  For guidance on microbial ingress testing, see 
Guidance on Premarket Notifications for Intravascular Administration Sets, 
https://www.fda.gov/downloads/MedicalDevices/D  eviceRegulationandGuidance/
G  uidanceDocuments/ucm070850.pdf. 
   
10. Simulated Clinical Use Testing
For devices that include sharps injury prevention features, we recommend that you conduct 
simulated clinical use testing and provide an analysis of the results from simulated clinical 
use testing and a summary of the results and conclusions.  If your sharps injury prevention 
feature is currently legally marketed as a part of ano ther device, you may identify that device 
i n lieu of performing simulated clinical use testing. 
Simulated use testing mimics actual clinical use by using patient substitutes (e.g., 
instructional models) rather than actual patients.  Bench testing recommended in  section 7 
may also serve as part of simulated testing if done by health care professionals.  The use of 
fruit as an instructional model may mimic a subcutane ous (SC) or intramuscular (IM) route  
of adm  inistration, but is not feasible simulation of IV administration.  S imulated use test ing 
helps :  isolate problems with the device 
  optimize the device design 
  identify deficiencies in labeling 
  evaluate the type of training needed for device users. 
 
There are no standardized, validated methods to simulate clinical use of sharps injury 
prevention features.  We recommend that you devise a protocol specific for your device.   
Whenever possible, p rotocols should be based on statistical considerations, such as sample 
size, response variables, pass/fail criteria, comprehensive report forms/questionnaires, proper 
                                                 
4  Needleless Systems are those that allow repeated access to a patients vascular system 
without the use of sharps.  Fluid flow through the system may be uni or bi-directional, with 
the latter enabling the user to administer or withdraw fluids or medication.  Needleless 
mechanisms generally include three types: pre-pierced septum and blunt cannula; valved 
connector (also called reflux valve); and capped Luer connector.    
  10   Contains Nonbinding Recommendations  
 
controls, and appropriate statistical test methods.  The protocol should be comprehensive , in 
other words it should:   
  state a clear objective  
  include a determination of sample size 
  explain how the number of evaluators was determined 
  explain how evaluators were selected 
  define terms and evaluation parameters used 
  explain how the data will be analyzed.  
 
Study Design   
The evaluators should include a variety of health care professionals who routinely use the 
type of device you are testing.  We believe  a simulated clinical use study using 
experienced health care professional volunteers generally helps avoid learning curve 
artifacts.   We recommend that the study also include observers who comment on the  
evaluators  adherence to protocol  and  their technique .  
 
We recommend that  you minimize b ias by selecting a s ufficient number of evaluators to  
each use a large enough sample of devices (such as 1/8 of the total number per evaluator ) 
to allow them to gain familiarity with the device and t hus provide objective opinions.  
The evaluators  should have no conflicting financial interest in the device, but they may 
be compensated for their time.  Studies conducted at more than one test site will decrease 
test bias.    
 
The device should be tested under conditions that simulate the critical clinical variables 
(e.g., models to simulate patients, gloved hands, dry and wet fingers, one -handed 
technique).  
 
You should make every effort to devise and execute the simulation properly.  You should 
include all data points in the analysis.  A deficient protocol or incomplete data is unlikely 
to provide sufficient information to support FDAs evaluation.  If  your protocol is 
deficient or your data incomplete, FDA may request additional simulated data.  
 
Evaluator Training  
We recommend that you instruct the evaluators on the study protoco l, to ensure 
uniformity of technique, simulation of adherence to universal precautions, consistent 
observations, scoring, and evaluations, and complete data collection.  
 
Report Forms   
The evaluators should record the results of testing on report forms  (i.e., e valuator 
questionnaires ).  Examples of report forms are available at Training for Development of  
  11   Contains Nonbinding Recommendations  
 
Innovative Technologies Project, http://www.tdict.org.  There should be ample space for 
narrative comments in your report forms.  We recommend that report forms contain:  
 
  general introductory questions for tracking purposes, such as date, time periods,
study site, evaluator's name  
 
  characteristics and experience of the evaluator (e.g., left or right handed, size of
ha nd according to a defined scale, gender, age, number of similar devices
used/day, work environment) 
 
  numbers and types of devices used by the evaluator  
 
  graded ability of the user to perform the intended function of the device such as 
injection, administe ring fluid 
 
  graded ability of the user to visualize important use factors, such as scales,
flashback 
 
  any required changes in usual technique, such as modifications of one -handed use 
 
  ability to maintain aseptic technique while extracting the device from packaging,
preparing, and using the device  
 
  ease of activation of the safety feature, and resistance to unintended activation 
 
  all adverse effects or problems encountered, whether its device or user related,
such as a sharps injury, multiple venipunctures required, safety feature failed to
remain activated, line disconnection 
 
  comparison of perceived or actual time required to use the safety device to the
control/legally marketed device and impact upon user acceptance 
 
  ability to detect activation of safety feature, and comments on associated
problems with detection that may be encountered during actual clinical use 
 
  opinion on extent of learning curve with use of device 
 
  a general assessment of the comparative acceptability of the device, including its
advantages and disadvantages 
 
  space for any other comments or noteworthy observations. 
 
Failed Tests  
We recommend that you report all data, including any failed tests.  If a test includes a 
failure, FDA recommends that you include a detailed explanation of t he failure and steps 
taken to ensure that the failure has been corrected.  If you redesign your device, FDA 
recommends that you repeat the simulated clinical use study and report its results, 
including any failed tests.  
 
  12   Contains Nonbinding Recommendations  
 
Sample Size Determination  
A sample size can be based upon a confidence interval of an observed failure rate in a test 
run of N devices.  Failure is defined as a needlestick injury or significant problem with 
the safety feature that may lead to an injury.  The upper limit of the interval serves as the 
worst case approximation for the true failure rate of the new device.  
 
The following tables, generated using STAT EXACT TURBO statistical software, list 
the upper 95% and 99% confidence limits based on the binomial distribution for an 
observed failure of 0, 1, 2, or 3 devices in a test sample of 100, 200, and 500 devices. 5 
 
Upper Bound of 95% Confidence Limit  
  Number of Devices Tested  
  100   200   500   1000  
Failures          
0   3.6%   1.8%   0.7%   0.3%  
1   5.4%   2.7%   1.1%   0.6%  
2   6.9%   3.5%   1.4%   0.7%  
3   8.3%   4.3%   1.7%   0.9%  
 
Upper Bound of 99% Confidence Limit  
  Number of Devices Tested  
Failures   100   200   500   1000  
0   5.2%   2.6%   1.1%   0.5%  
1   7.1%   3.6%   1.5%   0.7%  
2   8.8%   4.5%   1.8%   0.9%  
3   10.3%   5.3%   2.2%   1.1%  
 
Because a confidence interval generally involves both the upper and lower limits, when 
dealing only with one limit the actual confidence levels become 97.5% and 99.5% for 
95% and 99%, respectively, because the 5% and 1% differences are split equally between 
the two tails of the distribution curve.  
 
Thus, for example, if there were no failures observed in a test run of 500 devices, we 
would be 97.5% confident that the true failure rate was  no higher than 0.7% and 99.5% 
confident that it was  no higher than 1.1%.  If, on the other hand, there were two failures 
among 200 devices tested, the true failure rate could be as high as 3.5% (95% upper 
bound) or 4.5% (99% upper bound).  
 
                                                 
5 C.R.C. Handbook of Tables for Probability and Statistics, 2nd  Edition, William H. Be yer, 
Editor.  1982.  
  13   Contains Nonbinding Recommendations  
 
This model shows that smaller sample sizes increase the chance of accepting a device that 
has a potentially higher injury rate, even if no failures were reported.  However, we 
recognize that  sample sizes large enough to detect real differences in needlesticks rates  
are generally not feasible.  We recommend that simulated use testing of devices wit h 
sharps injury prevention features include a sufficient number of devices to provide 
confidence in the performance of the device.  FDA believes that for many devices with 
sharps safety features it is feasible to test 500 devices, which will enable detection of 
grossly defective devices at a 1% level (see previous confidence tables).   
 
With a sample size of 500, a successful study  should report zero failures of the protection 
feature.  No test control device is needed for comparison of a sharps injury endpoint since 
the endpoint is predetermined as a 0% rate of injury, based on the confidence intervals 
described above.  
 
FDA will consider alternative approaches to sample size determinations, when the 
proposed alternative is supported by an adequate scientif ic rationale. 
 
 
11.   Sterilization 
FDA recommends that you provide sterilization information in accordance with the Updated  
510(k) Sterility Review Guidance K90-1; Final Guidance for Industry and FDA.   
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/
GuidanceDocuments/ucm109897.pdf.  The device should be sterile with a sterility assurance 
 
level (SAL) of 1x10-6 using a sterilization cycle that has been v alidated in accordance with 
t he Quality Systems Requirements (QSR). 21 CFR 820.30. 
   
12.  Biocompatibility
We recommend that you conduct biocompatibility testing for your device as described in the 
guidance, Use of International Standard ISO-10993, Biological Evaluation of Medical 
Devices Part 1: Evaluation and Testing, https://www.fda.gov/downloads/medicaldevices/
deviceregulationandguidance/guidancedocuments/ucm348890.pdf.  We recommend that you 
select tests that are appropriate for the duration and level of contact and submit your pass/fail 
criteria.  We also recommend that you document the results in your design history as part of 
the QSR (21 CFR 820.30).  If identical materials and identical material processing ar e   used in 
 a predicate device with the same type and duration of contact, you may identify the predicate 
device in lieu of performing biocompatibility t esting. 
  14   Contains Nonbinding Recommendations  
 
13.  Labeling 
Labeling should provide sufficient detail to satisfy the requirements of  21CFR 807.87(e). 
The following information will assist you in meeting the requirements of 21 CFR Part 801. 6 
 
Intended Use  
We recommend that the intended use cle ar ly identify the therapeutic, preventative, or 

diagnostic use of the device and its use in the prevention of needlestick (sharps) injuries.  
 
Labeling should prominently indicate that the device with the sharps injury prevention 

feature is part of a system marketed by the submitter that is intended to be used with 

other devices or accessories as a part of that system. 
 
 
Directions for Use  
We recommend that your directions for use include  instructions for:  
 
  positioning the hands on the device at all times dur ing use for safe operation 
 
  aseptic technique, particularly when technique for using the device with the safety
feature differs from the techniques for commonly used devices without the safety
feature 
 
  deactivating the device after use 
 
  pre-decontamination procedures, such as pre-swabbing a septum 
 
  safely transport ing  sharps 
 
  disposing of a used device 
 
  visualizing blood flashback. 
 
 
We recommend that you include illustrations, pictures, posters, cards, and other visuals that may 
clarify and reinforce the d irections for use.   
 
We also recommend that your directions for use include instructions for  determining with 
certainty that any active safety feature is activated.  For example, if the safety feature is a active 
                                                 
6 Although final labeling is not required for 510(k) clearance, final labeling must comply 
with the requirements of 21 CFR Part 801 before a device is introduced into interstate 
commerce.  In addition, final labeling for prescription de vices must comply with 21 CFR 
801.109.  Labeling recommendations in this guidance are consistent with the requirements of 
part 801.  
 
  15 
  Contains Nonbinding Recommendations  
 
system, such as a stop mechanism, directio ns should instruct the user to listen for an audible 
click to ensure the mechanism has been activated.     
 
Precautions  
We recommend that labeling include any special limitations related to hand size or 
dexterity.  
 
Warnings  
We recommend that labeling warn that leakage of fluid may occur when disconnecting 
co mponents.  
 
Description of the Device  
We recommend that the description  includ e whether the device is :  
 	  single use only, non-toxic, non-pyrogenic fluid path, where applicable  
 	  sterile, if package is intact, undamaged, and protective caps are secure.  
 
Accessories  
In addition to the information above, we recommend that labeling for an accessory:  
 
 	  identify  the specific devices that are compatible with the accessory (e.g., trade 
names and/or models of syringes, device specifications)  
 
 	  instructions for connect ing the sharps injury prevention accessory to the device  
 
 	  instructions for discard ing used device.  
 
  16   Contains Nonbinding Recommendations  
 
Appendix I.   Abbreviations  
 
AAMI   Association for the Advancement of Medical Instrumentation  
ANSI   American National Standards Institute  
ASTM   American Society for Testing and Materials  
CDC   Centers for Disease Control and Prevention  
CDRH   Center for Devices and Radiological Health  
CFR   Code of Federal Regulations  
DAGID   Division of Anesthesiology, General Hosp ital, Infection Control, and 
Dental Devices  
DEHP   Diethylhexylphthalate  
DSMICA   Division of Small Manufacturers International and Consumer Assistance  
ECRI   Emergency Care Research Institute  
FDA   Food and Drug Administration  
ID   Inner Diameter  
ISO   International Organization for Standardization  
IV   Intravascular  
OD   Outer Diameter  
ODE   Office of Device Evaluation  
 
 
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