On June 14, 2023, FDA issued a guidance titled Content of Premarket Submissions for Device 
Software Functions.1 This final guidance supersedes the Guidance for the Content of Premarket 
Submissions for Software Contained in Medical Devices, issued on May 11, 2005. The final 
guidance issued on June 14, 2023, provides information regarding the recommended 
documentation sponsors should include in premarket submissions for FDAs evaluation of the 
safety and effectiveness of device software functions. In particular, the final guidance includes 
information to help determine a devices Documentation Level (formerly known as Level of 
Concern). The purpose of the Documentation Level is to help identify the minimum amount of 
information that would support a premarket submission that includes device software functions. 
Within the framework of the superseded guidance, infusion pumps were considered a device 
with a Major Level of Concern. Based on the devices risk in the context of the devices intended 
use, as discussed in the final guidance Content of Premarket Submissions for Device Software 
Functions, infusion pumps should generally address the recommendations for an Enhanced 
Documentation Level. The actual Documentation Level for your device may vary based on the 
specifics of your device. For more information about the Documentation Level and 
recommended documentation for a premarket submission, sponsors are encouraged to review the 
guidance Content of Premarket Submissions for Device Software Functions. 
 
1 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-premarket-
submissions-device-software-functions. Infusion Pumps Total Product Life 
Cycle 
 
Guidance for Industry and FDA Staff 
 
 
Document issued on: December 2, 2014. 
 
The draft of this document was issued on April 23, 2010. 
 
This document supersedes the Guidance on the Content of Premarket 
Notification [510(k)] Submissions for External Infusion Pumps, issued March, 
1993. 
 
 
For questions regarding this document, please contact Alan Stevens, General Hospital Devices 
Branch, Office of Device Evaluation at 301-796-6294 or via email at alan.stevens@fda.hhs.gov.  
 
For questions regarding safety assurance cases, please contact Richard Chapman, General Hospital 
Devices Branch, Office of Device Evaluation at 301-796-2585 or via email at 
richard.chapman@fda.hhs.gov. 
 
For questions regarding pre-clearance inspections, please contact Francisco Vicenty, Respiratory, 
Ear/Nose/Throat, General Hospital, Infectious Control, and Ophthalmic Devices Branch, Office of 
Compliance at 301-796-5770 or via email at francisco.vicenty@fda.hhs.gov.  
 
For questions pertaining to manufacturer reporting requirements, please contact Sharon Kapsch at 
301-796-6104 or via email at sharon.kapsch@fda.hhs.gov.  
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
 
Office of Device Evaluation 
Division of Anesthesiology, General Hospital, 
Respiratory, Infection Control, and  
Dental Devices 
General Hospital Devices Branch 
  Contains Nonbinding Recommendations 
 
Preface 
 
Public Comment 
You may submit electronic comments and suggestions at any time for Agency consideration to 
http://www.regulations.gov. Submit written comments to the  Division of Dockets Management, 
Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 
20852.  Identify all comments with the docket number FDA-2010-D-0194. 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 1694 
to identify the guidance you are requesting. 
 
 
 
 
 
 
 
   
 
 
 
 
 
 
   
  2  Contains Nonbinding Recommendations 
 
Table of Contents 
1.  INTRODUCTION ............................................................................................................................................... 4 
2.  BACKGROUND .................................................................................................................................................. 5 
3.  SCOPE .................................................................................................................................................................. 5 
4.  DEVICE DESCRIPTION ................................................................................................................................... 6 
5.  SAFETY ASSURANCE CASE........................................................................................................................... 9 
A.  GENERAL CONSIDERATIONS FOR SAFETY CASE DEVELOPMENT............................................... 10 
B.      HAZARD ANALYSIS ...................................................................................................................................... 12 
C.  PERFORMANCE TESTING ........................................................................................................................... 17 
D.  LABELING ........................................................................................................................................................ 29 
E.  ALARMS ............................................................................................................................................................ 32 
F.  SAFETY CONTROL MECHANISMS............................................................................................................ 32 
6.  510(K) PRE-CLEARANCE INSPECTION OF INFUSION PUMP MANUFACTURERS ....................... 33 
7.  POSTMARKET SURVEILLANCE OF INFUSION PUMPS ....................................................................... 34 
 
 
  3   
Infusion Pumps Total Product Life 
Cycle 
 
 
Guidance for Industry and FDA Staff 
 
 
This guidance represents the Food and Drug Administrations (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 listed on the title page of this 
guidance.  
 
 
1. Introduction 
The Food and Drug Administration (FDA) has developed this guidance document to assist 
industry in preparing premarket submissions for infusion pumps and to identify device features 
that manufacturers should address throughout the total product life cycle.  Infusion pumps, as 
described in 21 CFR 880.5725, are intended for use in a health care facility to pump fluids1 into a 
patient in a controlled manner.2  
 
The recommendations in this guidance are intended to improve the quality of infusion pumps in 
order to reduce the number of recalls and adverse events associated with their use.  The FDA 
believes that these recommendations will help mitigate current risk and reduce future risk 
associated with infusion pumps.   
 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances describe the Agencys current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited.  The use of the word should in Agency guidances means that something is suggested or 
recommended, but not required.   
 
 
                                                           
1 For purposes of this guidance, the term fluids refers to FDA approved drugs and licensed biological products.  
2 This guidance also includes recommendations for prescription infusion pumps intended for use by lay users in the 
home or elsewhere.  For purposes of this guidance, lay users or home users are users who receive infusion pumps 
from or on the order of a health care provider and who use the pumps under the supervision of a licensed practitioner 
in any setting outside a healthcare facility, including the home. 
  4   
2. Background 
The FDA has evaluated a broad spectrum of infusion pumps across manufacturers and has 
encountered problems with device software, human factors, reliability and manufacturing.  Based 
on an evaluation of reported adverse events and recalls, FDA believes that many injuries and 
adverse events may be avoided by improving the design verification and validation processes for 
these devices.  The most frequently reported infusion pump device problems are: software error 
messages, human factors (e.g., use error related to instructions for use, training, and other user 
interface issues), broken components, battery failure, alarm failure, and over infusion and under 
infusion.  In some reports, the manufacturer was unable to determine or identify the problem and 
reported the problem as unknown.  Subsequent analyses revealed that many of these were 
related to design problems that could be corrected during the design processes. This guidance is 
intended to improve the quality of infusion pumps and thereby reduce the incidence of these 
problems.   
 
 
3. Scope 
The scope of this document is limited to class II devices classified under the regulation, 21 CFR 
880.5725, which includes devices with the product codes listed in Table 1.  The product codes 
listed are those that currently fall within the scope of 21 CFR 880.5725.  Devices classified with 
future product codes created under 21 CFR 880.5725 following publication of this guidance are 
within the scope of this guidance document. 
  
Note that infusion pumps submitted as part of a class III system are subject to the premarket 
approval application (PMA) pathway.  While this guidance may provide valuable information 
regarding the elements to consider for a pump submitted as part of a PMA, such as hazard 
identification and sources of hazardous situations, not all items addressed in this guidance and 
recommended for a 510(k) submission would be relevant to a PMA submission.  In addition, 
additional items may be required for a PMA that would not be required as part of a 510(k) 
submission. 
 
 880.5725 Infusion pump 
(a) Identification. An infusion pump is a device used in a health care facility to pump fluids 
into a patient in a controlled manner.  The device may use a piston pump, a roller pump, or 
a peristaltic pump and may be powered electrically or mechanically.  The device may also 
operate using a constant force to propel the fluid through a narrow tube which determines 
the flow rate.  The device may include means to detect a fault condition, such as air in, or 
blockage of, the infusion line and to activate an alarm.  
(b)  Classification. Class II (performance standards).   
 
Table 1 
Product code  Description 
FRN  Infusion pump 
MEA  Patient controlled analgesia (PCA) infusion pump 
MEB  Elastomeric infusion pump 
LZG  Insulin infusion pump 
OPP  Insulin bolus infusion pump 
LZH  Enteral infusion pump 
  5   
MRZ  Infusion pump accessories 
PHC  Infusion Safety Management Software 
 
For purposes of this guidance document, FDA defines the infusion pump system to include the: 
 
  Infusion pump; 
  Fluid infusion set for the complete fluid pathway from, and including, the drug reservoir or 
fluid source container (e.g., bag, cassette, vial, syringe), infusion set, extension sets, filters and 
valves, clamps, up to and including the patient connection; 
  Components and accessories (e.g., power cord, wireless controller); 
  Network (i.e., any device or system physically or wirelessly connected to the infusion pump); 
  Patient; 
  Environment of use (e.g., clinical setting, temperature, humidity); and 
  User (e.g., health care provider, lay user, biomedical technicians). 
 
If you intend to provide or recommend particular disposable functional devices for use with your 
infusion pump, such as infusion sets or cassettes, whether manufactured by you or another firm, 
you should identify these devices and whether they are legally marketed.  Please note that for 
purposes of this guidance document, FDA considers such disposable devices to be part of the 
infusion pump system.  Your device should be evaluated as a system, and the focus of the 
evaluation is on your product and its performance within the context of the infusion pump system. 
 
In some instances, an infusion pump in conjunction with the fluid it delivers may be considered a 
combination product.  See 21 CFR 3.2(e).  If marketed as a combination product, additional 
regulatory requirements may need to be addressed for the combination product.  For additional 
information about combination products, please contact the Office of Combination Products 
(OCP) at combination@fda.gov, or see the OCP webpage at 
http://www.fda.gov/combinationproducts/default.htm. 
 
 
4. Device Description  
We recommend that you identify your device by the regulation and product code described in 
Section 3. Scope.  In your 510(k) submission, you must provide a statement indicating your 
device is similar to and/or different from other products of comparable type in commercial 
distribution, accompanied by data to support the statement, as required by 21 CFR 807.87(f).  
Side by side comparisons, whenever possible, are desirable. 
 
In addition to providing the information required in a premarket notification submission under 21 
CFR 807.87, you should include the following descriptive information about your device: 
 
  A clear statement of the indications for use. The indications for use should address:  
  the intended use environment; 
o
  the intended route(s) of administration for infusion; 
o
  any specific uses for the infusion pump (e.g., PCA is a generally accepted specific 
o
use); and 
  the indicated treatment population. 
o
 
  6   
  FDA recommends that submissions include the documents that result from the design input 
and output processes that define the device (i.e., functional, performance, and interface 
characteristics) in engineering terms.3 There may be several such documents, covering the 
major hardware and software components of the system. 
  Provide a detailed description (including, where appropriate, assembly drawings, bill of 
materials, schematics, and/or specification control documents) of the pump and its functional 
components and accessories, including: 
 
  The infusion delivery mechanism; 
o
  The bolus mechanism; 
o
  The drug reservoir; 
o
  Pump tubing and connectors (built-in or external to the pump); 
o
  A user-interface, consisting of the programming unit, display unit, audio and tactile 
o
notification units; 
  Power supply; 
o
  Pump battery and circuitry to charge and monitor the battery; and 
o
  A communication interface, including network components and interfaces to other 
o
devices and systems. 
 
  You should describe the principle of operation of the infusion pump (i.e., the scientific 
principles behind how the device achieves its intended use). 
 
  If the infusion pump is labeled for use with a specific device, drug, or biologic, the labeling of 
the products should be consistent and you should provide the FDA approved labeling for that 
referenced device, drug, or biologic.4   
 
  For each route of administration identified in your statement of intended use, you should 
identify a legally marketed drug or biologic to demonstrate that at least one such product is 
approved or licensed for infusion through the pump for the proposed route of administration 
and at the proposed dosage.  You should provide the FDA approved labeling identifying the 
proposed route of administration for the identified drug or biologic. 
 
  If your infusion pump is intended for transport or ambulatory use, you should describe how it 
is designed for mobility, various environmental conditions (e.g., water exposure, altitude, 
electromagnetic interference), and ruggedness. 
 
  If your infusion pump is intended for lay use, you should describe how the device has been 
designed to be used by the lay user population, which often has limited or no clinical 
background, and how you have mitigated hazards arising from lay use. It is recommended that 
you reference the FDAs Guidance on Medical Device Patient Labeling 
(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/uc
m070782.htm).  FDA has issued a draft guidance on this topic,  Draft Guidance for Industry 
and Food and Drug Administration Staff - Applying Human Factors and Usability 
                                                           
3 Your firm may refer to these documents as system specifications, design requirements, requirements 
specifications, or by other similar names. 
4 FDA will consider whether the infusion pump and the specified drug or biological product constitute a combination 
product, as defined in 21 CFR 3.2(e).   
  7   
Engineering to Optimize Medical Device Design 
(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/uc
m259748.htm).  When finalized, this guidance will represent FDAs current thinking on this 
topic.    
  
  You should state if your device is capable of being remotely controlled from a distance and 
describe the measures incorporated to address hazards. 
 
  If your infusion pump incorporates or is intended to incorporate radio-frequency (RF) wireless 
technology (e.g., IEEE 802.11, Bluetooth, Zigbee), the description should include information 
about the specific RF wireless technology and characteristics, the RF wireless technologys 
use and functions (e.g., remote monitoring or control, software updates), the data to be 
transmitted including any alarms transmitted wirelessly, quality of service (QoS) needed, 
wireless security measures and protocols, and any limitations or restrictions relating to 
coexistence with other RF wireless technology and electromagnetic compatibility of the 
 
wireless technology.  Please refer to the FDAs guidance, Radio Frequency Wireless 
Technology in Medical Devices 
(http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm07
7210.htm). 
 
  If your infusion pump contains software, provide a detailed description of the software design, 
including key elements, such as: 
  A drug library or other dose error reduction mechanism; 
o
  A real time clock (RTC); 
o
  On-board memory; 
o
  Pump log; 
o
  Alarm handler; and 
o
  Watchdog timer. 
o
 
  You should describe any communication between your device and a hospital information 
management system or another device. 
 
  You should describe the user interface components of the pump, including keypads, control 
menus, data entry screens, displays, indicator lights, alarms, auditory and tactile feedback, 
infusion sets, cassettes, free-flow prevention mechanisms, tubing, latches, doors or other 
components or accessories of the physical pump that may be manipulated. 
 
  You should describe how you will market the device (e.g., sterile, single use, multi-patient use, 
home use). 
  
In addition to providing the descriptive information requested above, we recommend that you 
provide a table comparing your device to a legally marketed predicate device.  This table should 
include the following: 
 
  The indications for use for each device, including the patient population for which the devices 
are intended (i.e., neonate, infant, pediatric, adult) and the intended use environment. 
 
  The specifications for the devices, including but not limited to, flow accuracy specifications, 
time to occlusion alarm, dimensions, weight, ingress protection, power, and units of delivery. 
  8   
 
  The technological features of the devices. 
 
You should describe how any differences in technology may affect the comparative safety and 
performance of your device.   
 
 
5. Safety Assurance Case 
Infusion pump 510(k) submissions typically include changes or modifications to software, 
materials, design, performance, or other features compared to the predicate.  Accordingly, FDA 
expects that most new devices (as well as most changed or modified devices5) will have 
differences in technological characteristics from the legally marketed predicate device even if 
sharing the same intended use.  Under section 513(i) of the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act), determinations of substantial equivalence will rely on whether the information 
submitted, including appropriate clinical or scientific data, demonstrate that the new or modified 
device is as safe and effective as the legally marketed predicate device and does not raise different 
questions of safety and effectiveness in comparison to the predicate device.    
 
In determining whether your new, changed, or modified infusion pump is substantially equivalent, 
FDA recommends that you submit your information through a framework known as a safety 
assurance case.6  
 
The safety assurance case (or safety case) consists of a structured argument, supported by a body 
of valid scientific evidence that provides an organized case that the infusion pump adequately 
addresses hazards associated with its intended use within its environment of use.  The argument 
should be commensurate with the potential risk posed by the infusion pump, the complexity of the 
infusion pump, and the familiarity with the identified risks and mitigation measures.   
 
                                                           
5 Based on FDAs analysis of these devices, FDA expects that most changes or modifications to infusion pumps 
could significantly affect the safety or effectiveness of the devices and would therefore require submission of a new 
510(k).  See 21 CFR 807.81(a)(3). Note that a change to the intended use or technology of a 510(k)-cleared device 
may render the device not substantially equivalent (NSE) to a legally marketed predicate.  For detailed information 
about substantial equivalence and 510(k) submissions, refer to the FDA guidance entitled, The 510(k) Program: 
Evaluating Substantial Equivalence in Premarket Notifications [510(k)] 
(http://www.fda.gov/downloads/MedicalDevices/.../UCM284443.pdf). Any such device may thus be a class III 
device and require a premarket approval application (PMA), unless the device is reclassified under section 513 of the 
Federal Food, Drug, and Cosmetic Act.   
6 For more information about assurance case reports, see, for example:  Graydon, P., J. Knight, and E. Strunk, 
Assurance Based Development of Critical Systems, Proc. of 37th Annual International Conference on Dependable 
Systems and Networks, Edinburgh, U.K., 2007; Kelly, T., Arguing Safety  A Systematic Approach to Managing 
Safety Cases, Ph.D. Dissertation, University of York, U.K., 1998; Kelly, T., Reviewing Assurance Arguments - A 
Step-by-Step Approach, Proc. of Workshop on Assurance Cases for Security - The Metrics Challenge, Dependable 
Systems and Networks, July 2007; Kelly, Tim, and J. McDermid, Safety Case Patterns  Reusing Successful 
Arguments, Proc. of IEE Colloquium on Understanding Patterns and Their Application to System Engineering, 
London, Apr. 1998; Weinstock, Charles B. and Goodenough, John B., Towards an Assurance Case Practice for 
Medical Devices, Carnegie Mellon Software Engineering Institute, October 2009; Hawkins, Richard, et. al., A New 
Approach to Creating Clear Safety Arguments, Safety-critical Systems Symposium, Southampton, UK, February 
2011; UK Ministry of Defence, Defence Standard 00-56, Safety Management Requirements for Defence Systems  
Part 1 and Part 2, June 2007. 
  9   
Safety cases are device specific and depend on manufacturer-specified design requirements,7 
associated hazards, design specifications, and other design control documentation. For this reason, 
any newly developed device should have its own unique safety case.  If you are submitting a 
510(k) for modifications to a legally marketed infusion pump for which no safety case exists, you 
should develop and submit a safety case for your infusion pump. 
 
Safety assurance cases are best developed in parallel with the development of the device. 
Constructing your safety case in concert with the device will not only allow for better safety 
controls, claims, arguments, and evidence, it may reduce the costs of retrospective mitigations if it 
is determined that a finished design is not adequately safe.  
 
You are encouraged to use previously developed high-level safety case structures, or patterns, for 
infusion pumps.  Past safety assurance cases are useful as examples and may provide a basis for a 
development framework.  However, you should ensure that any previous cases used are 
applicable to the system being developed.  
 
To maximize the benefit of the safety case, you should maintain and refine your safety case 
throughout the life of the infusion pump.  During development, maintenance, and refinement of 
your safety case, you should address the full lifecycle of the infusion pump within your safety 
case. 
 
FDA is not prescribing the formatting or presentation style used to develop your safety case. The 
recommendations contained in this guidance document are intended to provide assistance and 
facilitate the development and documentation of the safety case.  
 
Section 5A provides guidance on the development of the safety case and Section 5B  Section 5F 
provide guidance on elements that will make up the content of the safety case. 
 
 
A.  General Considerations for Safety Case Development 
 
The three main elements of a safety assurance case are: 
 
1. Claim: Statement about a property of the system or some subsystem. 
 
2. Argument: Links the evidence to the claim.  Arguments can be deterministic, 
probabilistic, or qualitative.  The argument describes what is being proved or 
established, identify the items of evidence you are appealing to, and the reasoning 
(inference, rationale) that the evidence is adequate to satisfy the claim.  Arguments 
may also introduce sub-claims or assumptions which require further exposition.  In 
addition to demonstrating that the evidence is adequate to satisfy the claim, the 
argument should also address the confidence in the sufficiency of the evidence.  
 
                                                           
7 Throughout this guidance document, the term design requirement is used consistent with 21 CFR Part 820 
Subpart C. 
  10   
3. Evidence: Information that demonstrates the validity of the argument.  This can 
include facts (e.g., based on observations or established scientific principles), 
analysis, research conclusions, test data, and expert opinions. 
 
These elements of a safety case provide an argument that hazards caused by the device have been 
adequately addressed. This is accomplished through a thorough analysis of hazards and 
implementation of adequate controls to address the hazards.  
 
Within a single safety case, there will be multiple layers of claims and arguments, with increasing 
levels of specificity as the safety case approaches the evidence level. Your safety case should 
make a claim about the safety of your infusion pump.  The safety case for a specific infusion 
pump should incorporate the following: 
 
  The persons for whose use the device is represented or intended; and 
  The conditions of use for the device, including conditions of use prescribed, 
recommended, or suggested in the labeling or advertising of the device, and other intended 
conditions of use. 
 
The safety case should then progress to establishing that causes of the device hazards are 
adequately addressed within its context of use and demonstrate through evidence the effective 
implementation of the hazard mitigations. 
 
The following recommendations are based on our experience reviewing safety cases. 
 
  A separate argument structure demonstrating the completeness of the hazard analysis 
process, including techniques, procedures and results to assure that hazards present within 
the safety case are accurate and complete. This concept is often referred to as a confidence 
case. 
 
  Depending on the complexity of the infusion pump, it is useful to provide specific 
argument structures for certain domains, such as software, human factors and reliability. 
 
  Arguments should include justification for the selection of acceptability criteria for safety 
controls. These can be integrated into the safety case directly. 
 
  A traceability analysis is useful in demonstrating that all identified hazardous situations 
have at least one corresponding control and that all controls have been verified and 
validated in the final device design. 
 
  There are commonly used safety case formats. If you elect to submit a safety case using 
your own format, we recommend that you provide an executive summary to assist the 
FDA in navigating your safety case. 
 
  FDA review of safety cases includes the use of postmarket data to confirm the validity of 
safety case arguments. You may find it useful to conduct a similar exercise during your 
own internal review. 
 
  11   
  Manufacturers have benefited from early interaction with FDA on development of their 
safety case. FDA feedback may be obtained through the pre-submission process. Please 
refer to the FDAs guidance, Requests for Feedback on Medical Device Submissions: The 
Pre-Submission Program and Meetings with FDA Staff Guidance 
(http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Guidanc
eDocuments/UCM311176.pdf).  
 
 
B.  Hazard Analysis 
The objective of the hazard analysis is to identify hazards and potential causes of the hazards.  
Specifically, the objective is to identify circumstances in which users or patients are exposed to a 
potential source of harm. 
 
FDA has identified infusion pump system hazards, as shown in Table 2.  Your safety case should 
provide an argument demonstrating that causes of these system hazards have been adequately 
addressed for your device.  
 
Table 2  Infusion Pump System Hazards 
 
Infusion Pump System Hazards  System Hazard Definitions 
Infusion Delivery Error  Intended medication selected and delivery attempted, but 
failure to deliver within the right time, dose, volume, 
patient, or anatomical or physiologic site specifications. 
This can include over-delivery, under-delivery or delay 
in delivery situations. 
Incorrect Therapy  Failure to select or deliver the intended medication 
because the wrong substance was selected for delivery. 
Biological/Chemical Contamination  Unintended contact with biological or chemical 
substance, or unintended patient or provider physiologic 
response to intended biological or chemical substance. 
Traumatic Injury  Burns, cuts, abrasions, air embolisms, electric shock, etc. 
 
In developing your safety case, you should provide a hazard analysis for your infusion pump to 
identify the causes of the system hazards. All hazards should be evaluated within the context of 
the persons for whose use the device is represented or intended and the conditions of use for the 
device, including conditions of use prescribed, recommended, or suggested in the labeling or 
advertising of the device, and other intended conditions of use.  
 
When identifying hazards, you should consider hazards occurring from the following: 
 
  Systematic and random failures; 
  Failures due to normal or abnormal use during operational use, including sequences of use 
resulting in failure; 
  Predictable misuse; 
  Common cause failures; 
  Failures caused by system, sub-system, or component interactions; 
  Operating environment; 
  Energy sources (e.g., mechanical, electrical, magnetic, thermal); 
  12   
  Exposure to chemical or biological substances;  
  Intentional and unintentional security breaches; 
  Human factors;  
  Storage and transport; and 
  Maintenance. 
 
In addition to utilization of hazard analysis techniques, such as those identified in ISO 14971 
(e.g., fault tree analysis, preliminary hazards analysis, hazards and operability studies, hazard 
analysis and critical control point, failure modes and effects analysis), you should consider 
information available to you on similar infusion pumps as part of your hazard analysis, including 
published literature, customer complaints, Medical Device Reports (MDR), recall databases, user 
feedback, and other relevant sources. 
 
In Tables 3-10, FDA has provided examples of hazards and causes that may result in the 
occurrence of a hazardous situation.  The purpose of FDA identifying specific hazardous 
situations and their causes is to provide an example framework for how to conduct your own 
analysis.  You should conduct a thorough analysis for your infusion pump to identify any 
additional hazardous situations for your device and the foreseeable sequences of events that may 
result in any of the hazardous situations.  Individual pump designs, environmental conditions, and 
conditions of use for the device will dictate what hazards should be identified and mitigated. 
 
FDA recommends that the hazard analysis include a process for identifying initiating events and 
sequences of events for each hazardous situation throughout all aspects of device use (e.g., drug 
loading, priming, programming, infusion). 
 
Sources of hazardous situations: 
  Operational (Table 3)   
  Environmental (Table 4) 
  Electrical (Table 5) 
  Hardware (Table 6) 
  Software (Table 7) 
  Mechanical (Table 8) 
  Biological and Chemical (Table 9) 
  Use (Table 10) 
 
Table 3  Operational Sources 
Hazard  Potential Causes 
Air in Infusion Line  Incorrect/incomplete priming processes 
Broken, loose, or unsealed delivery path 
The pump is unable to release gas or air 
The pump is set up with an incompatible infusion set 
Occlusion   Delivery path obstructed, e.g., kinked tubes 
Chemical precipitation inside the delivery path 
Bolus occurring after an occlusion 
Uncontrolled Flow of Infusate (e.g.  Valves in the delivery path are broken 
free flow)  The pump is positioned much higher than the infusion 
site, causing unintentional drug flow 
The delivery path is damaged, creating a vent on the path 
that allows unintentional gravity flow 
Retrograde Flow of Infusate (e.g.  The pump is positioned much lower than the infusion 
  13   
Reverse Flow)  site, causing the pump to siphon 
The delivery path is damaged, creating a vent on the path 
that diverts an intentional drug flow from reaching the 
user 
Excessive bolus administration due  The bolus history records are corrupted, making the user 
to too many bolus requests from  unable to track previously received boluses 
the user   
The programmed bolus dose is  Algorithmic errors 
delivered unevenly over its 
The pump motor does not operate as intended 
specified duration 
Infusate Leakage  Loose connection between parts of the delivery path 
Broken drug reservoir 
The actual flow rate does not  Air pressure within the pump is much lower than the 
match the programmed infusion  ambient air pressure 
rate  Pumping mechanism out of calibration 
The drug reservoir is detached  The drug reservoir compartment is broken or opened 
during normal pump use 
 
Table 4  Environmental Sources 
Hazard  Potential Causes 
Failure to operate / Pump  Temperature / Humidity / Air pressure too high or too 
malfunction  low 
The pump is exposed to pathogens,  Contamination due to spillage / exposure to toxins  
allergens, or other hazardous  Battery leak 
substances 
Disruption/malfunction of pump  Electromagnetic interference (EMI) related to:  
due to electromagnetic interference  -  Radiofrequency (RF) emitters, e.g., mobile radios, 
(EMI)   cellular telephone  
-  Electrostatic discharge (ESD) 
-  Conducted RF, e.g., via power line 
-  Poor AC power quality, e.g., voltage surges or sags. 
Magnetic fields: e.g., electric motors, power lines 
 
Inadequate shielding, filtering, or other electromagnetic 
compatibility (EMC) design or  mitigation 
 
Table 5  Electrical Sources 
Hazard  Potential Causes 
Overheating  Incorrect or loose interconnections between devices 
Supply processor charge too high 
Insufficient cooling/faulty heat sink 
 
Charge Error  Battery could not be charged 
AC supply exceeds limits 
Battery voltage exceeds limits 
Supply Voltage Error 
Battery depleted 
Voltage conversion failed 
Battery Failure  Battery voltage too low 
Battery depleted 
Battery overcharged 
Leakage Current too high  Inadequate shielding 
  14   
Short circuit 
Circuit failure  Short circuit  
High impedance 
Low impedance 
Electrically conductive, corrosive fluid ingress 
Electromagnetic compatibility   Electromagnetic interference (EMI) [** see list in table 4] 
 
Table 6  Hardware Sources 
Hazard  Potential Causes 
System failure  Malfunctioning component 
Synchronization error between pump components  
Watchdog failure 
Reliability specification not met 
Network error  Network congestion 
Communication problem 
Loss of (wireless) signal 
Pump not compatible with networked / integrated device 
Memory failure  Attempted write to memory failed 
Critical value data integrity error 
False watchdog interrupt 
False alarm  Device or sensor contaminated 
Device or sensor out of calibration 
Failure to alarm  Sensor failure 
Incorrect dose value entered  Key de-bounce prevention failed 
 
Table 7  Software Sources 
Hazard  Potential Causes 
Data error  Failure to backup 
Data store/retrieval error 
Communication problem 
Software runtime error  Buffer overflow/underflow 
Null pointer dereference 
Memory leak 
Uninitialized variable 
Incorrect dynamic libraries 
System malfunction  Software runtime error 
Communication error 
Corrupted infusion commands  Data store/retrieval error 
Communication problem 
Pump could not be silenced  Alarm priority set incorrectly 
Incorrect software version  Software updates not installed 
Incorrect drug library loaded 
Incorrect version installed 
Failure to alarm / False alarm  Sensor failure 
Alarm priority set incorrectly 
Incorrect settings of alarm thresholds 
 
 
Table 8  Mechanical Sources 
Hazard  Potential Causes 
Unable to set dose, start/ stop/ reset  Broken part (e.g., broken keypad) 
pump, silence alarm   
Incorrect dose value entered  Key stuck / depressed 
  15   
Failure to alarm  Speaker / Audio unit failure 
Stress from various sources: random impacts (e.g., 
dropped device), vibration, shear, fatigue, rupture, 
fracture, wear, and temperature or force induced 
Physical Damage to pump  deformation 
Fluid ingress 
Damage to power cord 
Pump stops infusion  Pump motor fails 
Pump unable to stroke 
 
Table 9  Biological and Chemical Sources 
Hazard  Potential Causes 
The pump is exposed to pathogens,  Inadequate device cleaning 
allergens, or other infectious  Device contaminated by blood/leaking fluid 
substances  Failure to flush 
  The pump is connected to non-sterile infusion sets or 
reservoir 
Packaging of the pump is damaged prior to its use 
Infusion site infection  The user is local skin reaction to the infusion set or 
infusion set adhesive 
The user fails to rotate infusion sites  
Chemical precipitation inside the  Inadequate device cleaning 
delivery path 
Drug not compatible with device materials 
Physical damage to pump  Inadequate device cleaning or disinfection 
  Damage to device materials from adsorption of the drug  
Loss of drug potency  Adsorption of drug to device materials due to 
incompatible device materials 
Temperatures exceeds drug specifications 
Toxicity  Materials of construction are not biocompatible 
Drug leaches chemicals from device 
Presence of natural rubber latex 
 
Table 10  Use Sources  
Hazard  Potential Causes 
User does not understand how to  User interface design is confusing  
initiate pump operation  
User is confused by pump operation 
Note: Can apply to lay users 
particularly    The instructions for use are insufficient or lacking 
The training was insufficient or lacking 
 
The pump is programmed  Secondary infusion not properly initiated by the user  
incorrectly  The instructions for use are confusing for the user  
The user enters incorrect configuration parameters (e.g., 
blood glucose reading, drug concentration) 
The user accidentally touches the pump console,  presses 
the wrong key, or double-strikes a key, changing or 
erroneously programming pump settings 
Infusion stopped  prematurely  The user forgets to resume the pump after pausing it 
User is unaware of battery capacity and does not notice 
its low status 
The user fails to detect or  Background noise or nuisance alarms cause user to fail to 
understand pump notifications  detect or to ignore them 
  16   
The user muffles the pumps speaker or other audio 
output, either intentionally or unintentionally 
Wrong medication or  User sets up pump with incorrect medication or incorrect 
concentration is delivered  concentration 
Medication is correct but user enters into pump the 
incorrect concentration or delivery rate  
Physical set up, such as routing of  User believes infusion is occurring but it is not 
tubing or selection of appropriate  User is required to perform programming task sequences 
tubing set is incorrect  beyond user expectations or capabilities 
User is confused about pump set-up, troubleshooting, or 
operation tasks 
Physical set-up of pump components is challenging for 
the user  
User works around or  Software configuration, possibly user-defined 
bypasses software limits on  configuration, is not applicable to current treatment and 
drug/dose parameters.   user is compelled to work around or bypass it  
Work around or bypass requirements are required so 
often the user does not attend to  displayed limits 
User ignores or misinterprets  Warnings are displayed so often that user ignores them  
software-generated warnings 
Warning statements are not sufficiently informative, 
meaningful or appropriate for the condition and user does 
not understand how to respond 
User misinterprets or  Pump operates differently than expected  
misunderstands pump status or  Pump operational mode indications are absent or not 
operational mode  communicated effectively  
Display characters not distinguishable and user cannot 
read them correctly or at all 
The pump is disconnected   The users actions cause the pump to be disconnected 
accidentally from the patient or the power supply 
Children, pets, pests or vermin tamper with or damage 
pump components 
Excessive bolus administration due  The user forgets previously received boluses or does not 
to too many bolus requests from  wait long enough for previous bolus to take full effect 
the user 
(Drug) Leakage  The user disconnects the pump incorrectly  
 
Children, pets, pests or vermin tamper with or damage 
pump components 
The drug reservoir is detached  The users actions cause the reservoir to be disconnected 
during normal pump use 
Tampering (for example, by a  Unauthorized tampering of pump settings  
patient during home use to adjust   
drug delivery)  Panel/door opened during infusion 
Infusion started when door open 
 
 
C.  Performance Testing 
Performance testing to verify/validate the pump design should assure that the related safety case 
claims are satisfied.  This includes specific attention to statistical elements (hypotheses, analyses, 
sample size and sampling, power), controls, minimization of bias, test parameters (endpoints), 
follow-up, and evaluation criteria. 
 
This performance testing should be conducted with the complete infusion pump system intended 
to be used with your device.  Each available configuration of the system should be verified and 
  17   
validated.  If representative configurations are used for verification or validation activities, you 
should describe how the collected data are relevant to configurations that have not been subject to 
the verification or validation activities. 
 
The amount and type of evidence required to support the indications for use and technology for a 
particular infusion pump varies.  You should identify all of the evidence that you rely on to 
support your claims of safety and effectiveness and to provide confidence that the evidence 
selected is complete. 
 
The premarket notification (510(k)) should include the following information for all design 
verification performance testing activities submitted in support of your safety case: 
 
1.  A description of the device design requirement being verified, including why it is 
essential to the proper functioning of the device; 
 
2.  A description of the unit under test and how it relates to the final, finished device; 
 
3.  The justification for the use of prototype or production equivalent devices or 
components during the design verification activity, if applicable; 
 
4.  An explicit statement of the acceptance criteria for the verification activity; 
 
5.  A detailed description of the verification method, including drawings and descriptions 
of the test apparatus where appropriate; 
 
6.  An explanation of how the verification test set up simulates actual clinical use 
conditions, if applicable; 
 
7.  The results of the verification activity; 
 
8.  An analysis of the verification activity results; and 
 
9.  An explicit statement of any conclusions drawn from the verification activity. 
 
The premarket notification should characterize the user population(s), use environment(s), and 
include the following information for all design validation performance testing activities: 
 
1.  A description of the design requirement implemented to address a user need or 
intended use, which is being validated; 
 
2.  A description of the unit used during the design validation activity and how it relates 
to the final, finished product; 
 
3.  The justification for the use of prototype or production equivalent devices during the 
design validation activity, if applicable; 
 
4.  A detailed explanation of how the validation activity simulates actual clinical and/or 
home use (or a description of the actual use conditions); 
 
  18   
5.  An explicit statement of the acceptance criteria for the validation activity; 
 
6.  The design validation method/protocol used; 
 
7.  The results of the design validation activity;  
 
8.  An analysis of the design validation activity results; and  
 
9.  An explicit statement of any conclusions drawn from the design validation activity. 
 
Use of Standards 
We encourage you to take advantage of any FDA-recognized standards and provide 
statements or declarations of conformity, as described in the FDAs guidance, Use of 
Standards in Substantial Equivalence Determinations 
(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/uc
m073752.htm).8  
 
References to standards within this guidance document do not mean that the standards must 
be complied with, or that they necessarily apply to your specific device.  Your safety 
assurance case should address the appropriateness of any standard to support clearance of 
your infusion pump. 
 
The safety case does not have to follow a prescribed or singular format. Similarly, ISO 14971 
states that the risk management file can be in any format. Therefore, we encourage you to 
leverage your existing risk management activities to avoid duplication in the development and 
documentation of your safety case. 
 
Operational Safety 
Infusion Delivery Accuracy  
Infusion delivery accuracy specifications should be appropriate for the intended use of the 
device and the testing should reflect the conditions of use for the device.  The safety case 
should include an argument for how the infusion delivery accuracy specifications are 
appropriate within the context of the indications for use, including the therapeutic range of 
the fluids intended to be infused by the system, where specific fluids are indicated.  When 
developing and verifying the accuracy specifications, you should consider the flow rates 
and duration of time over which the accuracy specification is defined. 
 
Each available configuration of the system should be tested, though testing of 
representative configurations may also be acceptable. Where representative tests are 
provided, you should describe how the collected data are relevant to the untested 
configurations.  In determining if a configuration is representative, you should identify the 
characteristics of your device that could affect the infusion delivery accuracy.  Some 
examples of characteristics that should be considered include: 
 
  Infusion sets: Length, diameter, number and type of flow restriction devices on the set, 
number and relative location of access points. 
                                                           
8 For more information on FDA recognized consensus standards, see 
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm.  
  19   
  Drug reservoir: Size, position relative to pump. 
  Pump model/configurations: Flow rate limits, volume limits. 
 
For a pump intended to maintain a constant set flow rate per your specifications, the data 
should demonstrate that the device can maintain a set flow rate over the complete course 
of the infusion within the designated accuracy. The testing should demonstrate adherence 
to specifications at the limits of the operational parameters. 
 
For a pump that does not maintain a constant flow rate, test results should be used to 
generate a representative flow profile.  This representative flow profile should be included 
in the device labeling.  Testing should include an assessment of infusion delivery accuracy 
at the minimum, intermediate, and maximum flow rates. You should provide a 
justification for choice of intermediate flow rate.  
 
For pumps that are capable of bolus delivery, test results should demonstrate that the 
accuracy of the bolus delivery is within specification.  Testing should be representative of 
how bolus delivery will occur in use and should include an assessment of bolus accuracy 
at the minimum and maximum bolus dose.  
 
Testing should also demonstrate that the device can maintain the specified flow 
characteristics despite changes in ambient temperature, fluid temperature, pressure (e.g., 
head-height, backpressure, atmospheric pressure), or fluid viscosity, which would 
reasonably be expected to be encountered according to the intended use of the device.  The 
effects of these factors should be discussed quantitatively in the labeling so that the user is 
made aware. 
 
Reliability Analysis 
Reliability includes component and system level analyses.  You should provide an 
analysis of your infusion pump system reliability.  The analysis should include a 
description of your systems reliability specification and the reliability activities 
completed to verify and validate that the specification has been met (e.g., design analysis, 
test plans, and test reports).  As part of the safety assurance case, the analyses and 
associated activities may take the form of claims, arguments, or evidence. 
 
Environmental Safety 
Applicable Standards 
We recommend that your device meet the applicable environmental safety standards.  In 
your 510(k) submission, you should present data or documentation demonstrating that 
your device meets the applicable safety standards. For the electromagnetic compatibility 
(EMC) aspects of environmental safety, see below. 
 
General Considerations 
The environmental standards that you use for your particular infusion pump should be 
appropriate for the environments of intended use.  For example, environmental hazards for 
a home use pump might be different from the hazards for a pump intended for use in a 
healthcare facility.  For this reason, we recommend that you comprehensively characterize 
the range of potential environmental hazards for your infusion pump and establish 
appropriate strategies to control the hazards.  
 
  20   
Your safety assurance case should identify and mitigate environmental hazards.  You 
should characterize the use environment and establish the measures to support the use of 
your infusion pump within its environment. 
 
Electrical Equipment Safety 
Applicable Standards 
We recommend that your device meet the applicable standards in ANSI/AAMI ES60601-
1:2012, entitled Medical electrical equipment  Part I: General requirements for basic 
safety and essential performance. In your 510(k) submission, you should present data or 
documentation demonstrating that your device meets the applicable standards. 
We recommend that mains-powered devices intended for home use should safely function 
without a protective earth ground as defined in ANSI/AAMI ES60601-1:2012, definition 
3.14, class II. See also the FDAs guidance, Design Considerations for Devices Intended 
for Home Use 
(http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Guidanc
eDocuments/UCM331681.pdf).   
 
Electromagnetic Compatibility 
If your infusion pump contains any electrical components, you should include in your 
510(k) submission information demonstrating the EMC of the device in its intended use 
environments. EMC is the ability of a device to operate properly in its intended 
environment of use (immunity) without introducing harmful electromagnetic disturbances 
into that environment (emissions). We recommend that your infusion pump be designed 
and tested for EMC in reference to IEC 60601-1-2:2014, entitled Medical electrical 
equipment  General requirements for basic safety and  essential performance  Collateral 
standard: Electromagnetic disturbances  Requirements and tests,9 or the IEC 60601-1-
2:2007, entitled Medical electrical equipment  General requirements for basic safety and  
essential performance  collateral standard: Electromagnetic Compatibility  
Requirements and tests.10  Alternatively the ANSI/AAMI/IEC versions of these standards 
can be referenced.  In addition to evidence of conformity with one of these applicable 
standards, you should provide summary information in your premarket submission to 
FDA describing the following:   
  the testing that was performed and how this was done;  
  the device functions and modes that were tested; 
  the device specific pass/fail criteria used, including the performance that was 
determined to be Essential Performance;  
  reference standards and any deviations or allowances that were taken;  
  any device modifications needed to pass the testing; and  
  appropriate labeling. 
 
Device manufacturers should consider appropriate levels of testing in accordance with the 
risks present in the intended use environments.  Depending upon the use environment, the 
                                                           
9 FDAs recognition of the 2014 version of the IEC 60601-1-2 is available at 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=32631.  
Please note that the 2014 version of the IEC 60601-1-2 standard includes a transition period through April 2, 2017 as 
noted in FDAs recognition. 
10 FDAs recognition of the 2007 version of the IEC 60601-1-2 is available at 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/detail.cfm?standard__identification_no=32628.    
  21   
immunity test levels might need to be raised, particularly if the testing is performed in 
reference to the general immunity testing specified in the IEC and ANSI/AAMI/IEC 
60601-1-2:2007 standard.11    
 
You should also assess the EMC of your device with common sources of disturbance to 
electrically powered medical devices that could be in the use location(s) and might  
interfere with the performance of the medical device.  These sources can include large 
electric motors, nearby radio and TV transmitters, radar, anti-theft systems (including tag 
deactivators), stereo speakers, and radio frequency identification (RFID). 
 
Radio Frequency Wireless Technology 
If your submission includes radio frequency (RF) technologies, you should include in your 
510(k) submission a complete description of the RF use.  Even when applications of RF 
wireless technologies comply with applicable technology standards and Federal 
Communications Commission rules, medical device safety and effectiveness concerns can 
exist.  For detailed information about possible hazards, refer to the FDA guidance on 
radio-frequency wireless technology, Radio-Frequency Wireless Technology in Medical 
Devices 
(http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/uc
m077210.htm).  Particular points you should address in your 510(k) include quality of 
service needed, data integrity, coexistence, security, and EMC.  Due to the increased use 
of RF wireless technology that operates in the same frequency range, you should address 
RF wireless coexistence via testing with other common applications of RF wireless 
technology that can be expected to be used in the environment of use.  The testing should 
also address the ability of two or more of your infusion devices to operate wirelessly in 
proximity.   
 
Hardware Safety 
Applicable Standards 
We recommend that your device meet the hardware safety standards of IEC 60601-1. In 
your 510(k) submission, you should present data or documentation demonstrating that 
your device meets the hardware safety standards. 
 
Software Safety 
Applicable FDA Guidances and Standards 
Please refer to the FDAs Guidance for the Content of Premarket Submissions for 
Software Contained in Medical Devices 
(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocument
s/ucm089543.htm), for a discussion of the software documentation that you should 
provide in the 510(k) submission.  We generally consider infusion pumps to be a Major 
level of concern for the purposes of software review. 
If the device includes off-the-shelf software, you should provide the additional 
information as recommended in the FDAs Guidance for Industry, FDA Reviewers and 
                                                           
11 Because the levels of electromagnetic disturbance in, for example, the home healthcare environment can exceed 
the default test levels for the hospital environment that are specified in IEC and ANSI/AAMI/IEC 60601-1-2:2007, if 
your device is specified for home use or use in transport, you should design your device to be immune to the 
disturbance levels that can be expected in these environments. 
  22   
Compliance on Off-the-Shelf Software Use in Medical Devices 
(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocument
s/ucm073778.htm).  
General Considerations 
You should provide a static analysis of all software in your infusion pump system. 
 
When providing a list of unresolved anomalies, you should include the following 
information for each unresolved anomaly: 
 
  A description of the anomaly from a symptom point of view and how it is 
manifested. 
  The location in the code where the anomaly occurs. 
  A description of how to fix the anomalous code. 
  A search of the software source code for other possible instances of the anomaly.  
For example, if the problem was an off-by-one error in an array, provide evidence 
that all arrays were checked for off-by-one errors. 
  Provide evidence that a coupling analysis was performed to identify all parts of the 
software that accessed the anomalous code and that no problems would arise 
because of accessing this anomalous code. 
  Provide an explanation for why the anomaly could not result in harm if it occurs. If 
justification is provided for not correcting the anomaly, you should provide any 
plans or timeframes for correcting the problem. 
 
Information Security 
We recommend that you describe how your software addresses information security as 
it relates to safety and effectiveness.  Information security is the process of preventing 
the modification, misuse or denial of use, or the unauthorized use of information that 
is stored, accessed or transferred from your device to an external recipient.  We 
recommend that your 510(k) include documentation demonstrating that your device 
design addresses the following four components of information security described 
below: Confidentiality, Integrity, Availability, and Accountability (CIAA). Please 
refer to FDAs guidance addressing cyber security in medical devices, Content of 
Premarket Submission for Management of Cybersecurity in Medical Devices 
(http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Guid
anceDocuments/UCM356190.pdf).  
 
  Confidentiality means data, information, or system structures are accessible only to 
authorized persons, entities and processes at authorized times and in the authorized 
manner, thereby helping ensure data and system security. (The assurance that no 
unauthorized users have access to the information.) 
   
  Integrity means data and information are accurate and complete and have not been 
improperly modified.  
 
  Availability means data information and information systems are accessible and 
usable on a timely basis in the required manner.  (The assurance that the information 
will be available when needed.)  
 
  23   
  Accountability means an authorized user is identified and authenticated before access. 
Network 
If your infusion pump is physically or wirelessly networked (e.g., hospital information 
system) you should include information in your 510(k) describing the purpose of allowing 
networked access to your infusion pump. Within your safety case, you should identify 
how the networked connection / capability could cause the manifestation of an infusion 
pump system hazard (e.g. infusion delivery error, incorrect therapy, contamination, or 
traumatic injury) and provide the supporting argument for how these are adequately 
addressed. 
 
Dosing Algorithms 
For infusion pumps that contain algorithms intended to provide dosing recommendations, 
we recommend that you include the following information in your 510(k) submission: 
    
  The dosing algorithms used within your device. 
 
  For each algorithm identified, you should include the algorithm in symbolic form, 
define all parameters in each algorithm and identify what parameters can be modified 
by the end-user. 
 
  For each algorithm identified, you should include clinical data or other justification 
(e.g., via scientific literature) for why you believe your algorithm is appropriate for 
your intended patient population. 
 
  Each algorithm should be verified and validated in your software documentation to 
show that the calculations made by the dose calculator are correct and this data should 
be included in your submission. 
 
Mechanical Safety 
Applicable Standards 
We recommend that your device meet the mechanical safety standards of IEC 60601-1. 
 
General Considerations 
You should consider sources of mechanical forces that may be exerted on the infusion 
pump or that the infusion pump may exert on other objects that could result in a hazardous 
situation. The evidence that you provide should demonstrate that the sources of the 
mechanical hazards are controlled and that the controls are effective. 
 
Biological Safety 
Biocompatibility 
Applicable FDA Guidance 
For information regarding biocompatibility, see Use of International Standard ISO-10993, 
'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' (Replaces 
#G87-1 #8294) (blue book memo) 
  24   
(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocument
s/ucm080735.htm).12 
 
Your infusion pump might be made of materials that have been well characterized 
chemically and physically in the published literature and have a long history of safe use. 
We recommend that if you consider the tests suggested in the referenced biocompatibility 
guidance document or material characterization testing discussed below to not be 
applicable or appropriate, you should provide adequate justification for omission of these 
tests. In such situations, FDA recommends documenting the use of a particular material in 
a legally marketed predicate device or a legally marketed device with comparable patient 
exposure in order to support omission of the recommended tests. 
 
To make a biological safety argument based on equivalence to a predicate, you should 
demonstrate that the route(s) of administration, materials of construction / processing and 
post manufacturing residuals are the same as the referenced predicate device intended for 
similar intended use and population. 
 
General Considerations 
Infusion pumps include components that contact the patient or user. You should evaluate 
the biocompatibility of materials in the components that have direct or indirect contact 
with the patient or user, and report the results in your 510(k) submission. 
 
You should provide a chemical and particulate characterization on the final, finished, fluid 
contacting device components demonstrating that risk of harm from device-related 
residues is reasonably low. For the assessment, we recommend the following: 
 
  For device-related chemical residual characterization, the Agency recommends 
performing a leachables and extractables (L&E) study using representative 
solvents based on the spectrum of polarity for sample preparation as it may not be 
practical to use all fluids which may interact with the fluid contacting pump 
surface.  Sample preparation for the L&E study should be based on the worst case 
scenario, i.e., exhaustive extraction conditions.  Qualitative and quantitative 
estimation of device-related residuals is recommended using an applicable library 
of reference chemicals.  A detailed study report showing sample preparation, 
analytical methods, a justification for specific solvents and extraction conditions 
used in chemical characterization, and a quantitative extraction profile would be 
recommended for device-related chemical residual evaluation.  For the L&E study, 
we recommend that you consider ISO 10993-18 Biological evaluation of medical 
devices  Part 18: Chemical characterization of materials, 2005.   
 
  For device-related particulate evaluation, you should follow current USP <788> 
Particulate Matter in Injections.  FDA considers USP <788> to be limited to 
evaluation of micron particles.    
                                                           
12 FDA has issued draft guidance on use of ISO 10993 in testing medical devices for biocompatibility, Use of 
International Standard ISO 10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing 
(http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM348890.
pdf).  When finalized, this guidance will represent FDAs current thinking on this topic and will supersede the Blue 
Book Memorandum cited above.   
  25   
 
  Device-related residual characterization alone may not provide appropriate 
information for risk of harm from device-related residues.  The Agency 
recommends a comprehensive risk assessment of the device-related residuals based 
on route of exposure, toxicokinetics and toxicodynamics, and allowable limits in 
the intended population proposed for the new device.  
 
Sterilization  
Applicable FDA Guidance 
You should provide the appropriate documentation recommended by the FDAs, Updated 
510(k) Sterility Review Guidance K90-1 
(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocument
s/ucm072783.htm). 
 
Reuse 
Infusion pumps and accessories intended for multiple patient reuse should include 
instructions for cleaning and disinfecting the device between uses in the device labeling.  
Also, where appropriate, consider specifying in your submission and labeling the number 
of times the device can be reused, with supporting information (see Shelf Life, below).   
 
If cleaning or high-level disinfection of the device is recommended in the labeling, you 
should provide validation to demonstrate that such cleaning or high-level disinfection 
procedures are adequate.  You should also demonstrate that after cleaning or high-level 
disinfection, the device continues to perform as intended.   
 
Numerous infusion pumps are used in the home environment. If your pump is indicated 
for home use, you should specify in the labeling the types of cleaning agents/products that 
are readily available to the average home-based user along with instruction for cleaning 
the device.  Validation of these procedures should be provided in your submission. 
 
In order to demonstrate that your device meets the performance specifications after 
cleaning or disinfection, you should provide bench data before and after an appropriate 
number of cleaning or disinfection cycles per your labeling.  FDA has developed draft 
guidance that discusses labeling a device with cleaning or disinfection methods, 
Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods 
and Labeling 
(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocument
s/ucm252999.htm).  When finalized, this guidance will represent FDAs current thinking 
on this topic. 
   
Shelf Life 
If your particular infusion pump contains sterile components or materials that could 
degrade over time, we recommend that you include a shelf life on the packaging.  
 
We recommend that you provide data to demonstrate that the sterility and performance of 
your particular infusion pump are maintained throughout any specified shelf life. If 
accelerated test methods are utilized, you should provide information validating that the 
test methods accurately simulate real-time conditions for your device.  For additional 
information, please see the FDAs guidance, Shelf Life of Medical Devices 
  26   
(http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Guidanc
eDocuments/UCM081366.pdf). 
 
Drug / Biological Product Stability and Compatibility 
If your infusion pump is indicated to deliver specific types of drugs or biological products, 
you should verify and validate that your infusion pump system does not adversely affect 
the drug or biological products being delivered by your infusion pump and that these 
products do not adversely affect your infusion pump system.13 
 
As noted in the labeling recommendations of this document, you should identify the 
particular drugs or biological products that you have evaluated for use with your device.  
 
Use Safety 
Applicable FDA Guidance and Standards 
For more information regarding use safety, see FDAs guidance, Design Considerations 
for Devices Intended for Home Use 
(http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Guidanc
eDocuments/UCM331681.pdf).  
 
In addition, FDA has issued draft guidance on this topic, Applying Human Factors and 
Usability Engineering to Optimize Medical Device Design  
(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocument
s/ucm259748.htm). When finalized, this guidance will represent FDAs current thinking 
on this topic.  
 
We encourage the use of the following standards, as recognized by FDA: 
  AAMI ANSI HE75 Design of Medical Devices; and 
  IEC 62366, Medical devices - Application of usability engineering to medical 
devices. (General). 
 
General Considerations 
Reports of device-related incidents and recalls have shown that patterns of use errors 
resulting from flaws in the design of the pumps user interface have led to patient harm.  
The term user interface denotes all components of the pump with which the user interacts, 
for example: 
 
  Keypads and/or control mechanisms; 
  Feedback mechanisms (auditory alarms, visual alarms, indicators, and other 
messages to users); 
  Design of graphical user interface, including responses to user actions, such as 
auditory and visual feedback, and changes in pump operation or programming; and 
  Directions for use.      
 
                                                           
13 For additional information on drug or biological product stability, see FDAs guidance documents on the CDER 
webpage (http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064979.htm) or  
CBER webpage 
(http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm). 
  27   
Use hazards associated with use of pumps are a unique form of hazard in that they can 
exist even when a pump operates in accordance with its specifications.  These hazards 
generally do not involve failures due to faulty mechanical, electrical or software 
components that are previously known or reasonably anticipated, but rather, arise 
specifically from interaction with a human operator.   
 
Additional considerations to address in your hazards analysis for human factor/usability 
issues should include: 
 
  Operator (user) interface component features and operation including overall logic 
of operation (interaction between the user and the device components and user 
interfaces); 
  Arrangement of user interface components for users physical interactions with the 
device; 
  Potential errors associated with atypical user actions or technique;  
  Legibility of visual information, including device labels and displays; 
  Audibility of aural information, including different alarm tones; 
  Potential difficulties associated with each possible setting or input available to 
operators; 
  Potential errors associated with input, selection or modification of critical 
treatment parameters; 
  Potential errors associated with non-standard or unusual parameter settings or 
default values; 
  Data transfer and communication inaccuracies; 
  Potential confusion due to non-standard, unfamiliar or ambiguous conventions or 
abbreviations; and 
  Potential confusion due to non-standard, ambiguous, or inadequate alarm condition 
or information messages. 
 
Human Factors Validation Study Report 
The submission should include a Human Factors Validation study report to confirm the 
design of the product-user interface.  For additional information on human factors design 
optimization see the FDAs Draft Guidance for Industry and Food and Drug 
Administration Staff - Applying Human Factors and Usability Engineering to Optimize 
Medical Device Design 
(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocument
s/ucm259748.htm).   
 
Clinical Investigation 
The safety assurance case report should include evidence to demonstrate that the 
hazardous situation controls are effective.  This may include an evaluation of the infusion 
pump under conditions of actual clinical use, in addition to the simulated use studies. 
 
During development of your safety assurance case report, you should consider your 
devices indications for use and technology.  Appropriate evidence to validate the intended 
use of the device should be included in the safety case report. Where information does not 
exist to make sufficient safety arguments on the basis of simulated use studies alone (e.g., 
  28   
different technological characteristics as compared to the predicate device), FDA 
recommends clinical investigation of the device.  
 
FDA has determined that an infusion pump is a significant risk device, as defined in 21 
CFR 812.3(m), and as such, any clinical investigation must therefore be conducted under 
an approved investigational device exemption (IDE). 21 CFR 812.20(a).  Sponsors of such 
studies must not begin their clinical investigations until FDA has approved the IDE 
application (21 CFR 812.20(a)(2) and 812.42), and the clinical investigation must comply 
with the following: 
 
  IDE requirements, 21 CFR Part 812 (21 CFR 812.2(a)); 
 
  Institutional review board (IRB) requirements, 21 CFR Part 56 (21 CFR Part 812, 
Subpart D); and 
 
  Informed consent requirements, 21 CFR Part 50 (21 CFR 812.100). 
 
D.  Labeling 
Premarket notifications must include proposed labels, labeling, and advertisements sufficient 
to describe the device, its intended use, and the directions for its use, as required by 21 CFR 
807.87(e). Where applicable, photographs or drawings should be supplied.  The following 
suggestions are aimed at assisting you in preparing labels and labeling that satisfy the 
requirements of 21 CFR Part 801.  
 
We recommend that you provide clear instructions for use that delineate the technological 
features of the specific device and how to use the device.   
 
We recommend instructions for use be evaluated by representative users to ensure that critical 
aspects of pump use and maintenance are clearly and completely communicated.  The results 
should be part of your 510(k) submission. 
 
Directions for Use 
As a prescription device, infusion pumps are not safe except under the supervision of a 
practitioner licensed by law to direct the use of such device and therefore must include 
certain information in the labeling for the practitioner to use the device safely and for the 
purpose for which it is intended, as required by 21 CFR 801.109.  Labeling must include 
adequate information for the safe use of the device by health care professionals, including 
indications, effects, routes, methods, frequency and duration of administration, and any 
relevant hazards, contraindications, side effects and precautions, as required by 21 CFR 
801.109. 
 
In addition to the labeling requirements in 21 CFR 801.109, including the prescription 
statement required under 21 CFR 801.109(b)(1), FDA recommends that the labeling contain 
the following information: 
 
  Indications for use, including: 
 
  Identify the fluids or fluid types as supported by the submission; 
o
  29   
  Use environment(s); 
o
  Route(s) of administration for infusion; 
o
  Indicate treatment population. 
o
 
  Cleaning and disinfection instructions for reusable infusion pumps and accessories.  If 
the pump is used in the home, please identify cleaning and disinfection agents available 
to the general public that are suitable for device reuse (cleaning and disinfection). 
 
  Alarm limits and ranges. 
 
  Default settings. 
 
  A complete representation of the user interface, including detailed depiction of screens 
and data fields and how they will be used to accomplish all clinical applications and 
possible configurations of the pump. 
 
  An identification of any dedicated administration set or the specifications and/or 
specific models of infusion sets that are appropriate for use with this pump. 
 
  Identify reservoir volume, selectable flow rates and profiles, and residual fluid volume 
remaining after the infusion is complete. 
 
  Describe any factors that may affect flow accuracy such as ambient temperature, fluid 
temperature, pressure (e.g., head-height, backpressure, atmospheric pressure), fluid 
viscosity, or changes in flow rate or bolus delivery (e.g., such as when titrating 
medications). 
 
  Define the accuracy specifications over the range of selectable flow rates and bolus 
volumes. This may include information such as: 
 
  Time period over which accuracy is specified; 
o
  Time to reach steady-state flow accuracy; and  
o
  Effect of infusion rate changes or bolus delivery on accuracy. 
o
 
  Define the bolus delivery rate, if applicable. 
 
  A description of the fluid(s) to be administered by the pump as indicated in the 
statement of intended use found in the labeling of the device, with a listing of tested 
products (e.g., blood products, enteral feedings and lipids, cytotoxic drugs or their 
characteristics).  In the warnings or contraindications section, please list known fluid 
characteristics that are not compatible with the infusion pump. 
 
  Comprehensive directions for preparation and use for all functions of the device. 
 
  Describe a method or methods that can be used to confirm that the device is in 
calibration for all relevant delivery features. 
 
  Description of all alarm or information messages and recommended actions when 
alarms or information messages are provided. 
  30   
  
For infusion pumps containing a reservoir, container, or other components contacting 
the drug or biological product being infused, include information regarding the stability 
and compatibility of those fluids with your device.14 
 
  All recommendations for infusion pump use regarding the fluids should be consistent 
with the FDA-approved labeling for the fluid products.   
 
  Warning statements on your device regarding the safety of use during diagnostic 
procedures, such as magnetic resonance imaging (MRI), x-ray, computed tomography 
(CT), or ultrasound.   
 
  Labeling should include all recommended information related to EMC, including 
reference to the appropriate standard, such as IEC 60601-1-2. 
 
  For devices with RF wireless technology capabilities, the labeling should include 
information about the exact RF wireless technology incorporated or able to be used 
with your device.  The information should contain specifics about the technology (e.g., 
IEEE 802.11 b), the frequency of operation and range, quality of service required for 
the claimed functions, data integrity, recommended security measures for the RF 
wireless technology (e.g., WPA2), coexistence and any limitations (e.g., distance 
between RF devices, EMC limitations). 
 
  If the pump is designed to be used by individuals with specific disabilities, those 
disabilities should be described in the labeling. 
 
 
Home Use Labeling 
We recommend all infusion pump labeling specify the environment in which the pump is 
intended to be used.  Infusion pumps that are intended for home use should also include 
instructions for use suitable for the lay user, who is to receive the device from or on the 
order of a health care provider and use the device under the supervision of a licensed 
practitioner.15  These instructions for use should contain the information recommended in 
the Directions for Use section above.  Home care pumps should include the device 
manufacturers toll free phone number for customer support on the device in the event the 
device labeling is misplaced or lost. See also the FDAs guidance Design Considerations for 
Devices Intended for Home Use  
(http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceD
ocuments/UCM331681.pdf). 
 
 
                                                           
14 See Section C. Performance Testing: Drug/Biological Product Stability and Compatibility. 
15 As described elsewhere in the section Directions for Use, these infusion pumps are prescription devices under 21 
CFR 801.109.  See footnote 2 for a discussion of lay users. 
  31   
E.  Alarms 
In response to a hazardous situation, a pump may issue an alarm.  Each alarm should be 
clearly indicated to the user. We recommend that your device meet the standards of IEC 
60601-1-8: Medical electrical equipment  Part 1-8: General requirements for safety  
Collateral standard: Alarm systems. Use of alarms as a hazard control mechanism should be 
justified in your safety assurance case. You should also address any risks of infusion delivery 
error associated with false positive alarms and false negative alarms. 
 
An alarm may be triggered due to one or more hazards, including, but not limited to:  
 
  Occlusion (supply side and patient side); 
  Air-in-line; 
  Free flow / Improper flow of fluid; 
  Depleted battery or No power;  
  Defective battery;  
  Low or Empty reservoir; 
  No reservoir; 
  Dose limit / Bolus limit exceeded;  
  Panel unlocked / door open; 
  Key pressed alarm; 
  Power on self test (POST) failure  issued when one of the POST tests fails; 
  ROM / RAM CRC test failure; 
  Tone test failure; 
  Pump mechanism failure; 
  Watchdog alarm  issued when the watchdog timer expires; 
  Overheating; 
  Drug library mismatch; and 
  Infusion set not loaded properly. 
 
 
F.  Safety Control Mechanisms 
An infusion pump may have safety control mechanisms to prevent or detect hazardous 
situations. These may include, but are not limited to: 
 
1.  Power on self test (POST) checks  performed during pump startup or initialization; 
2.  Battery test;  
3.  Stuck key test; 
4.  Tone test; 
5.  Pump mechanism failure test; 
6.  Watchdog interrupt tests; 
7.  (Periodic) System checks  including a CPU test and ROM / RAM CRC tests; 
8.  Air detection sensors 
9.  Environmental monitoring sensors 
10. Sensor checks  to check the proper functioning of sensors attached to the pump, if any; 
and 
11. Dose error reduction checks. 
  32   
 
Correct implementation of any safety control mechanism should be verified and validated. 
 
Your safety case should also address hazardous situations initiated by the safety control 
mechanism itself.16 Analysis of safety control mechanisms should address and mitigate the 
following: 
 
  The safety control mechanism action is not provided or followed; 
  The resulting action from a safety control mechanism is unsafe and results in a 
hazardous situation; 
  The safety control mechanism action occurs too early, too late, or in the wrong order. 
  The safety control mechanism action is stopped too soon or applied too long. 
 
 
6. 510(k) Pre-Clearance Inspection of Infusion Pump 
Manufacturers 
FDA may conduct a pre-clearance inspection of infusion pump manufacturers. 
 
Since 2003, FDA has seen a dramatic increase in the number of Class I recalls17 associated with 
infusion pumps.  FDA has also received numerous MDRs and complaints from consumers 
associated with the use of infusion pumps.  These recalls and MDRs suggest that infusion pump 
manufacturers may not have adequate quality system implementation at their manufacturing 
facility.  Subsequent FDA inspections have often identified violations of the Quality System 
regulation in these situations.  Thus, FDA finds that preclearance inspections may be necessary to 
reduce serious adverse events associated with the use of these devices. 
 
In determining whether a pre-clearance inspection is needed, FDA may consider, among other 
factors, whether: 
 
  It is a device that presents new technological characteristics; 
 
  An inspection of the facility has not occurred within the past two years; 
 
  An inspection has occurred within the past two years, but did not cover a similar 
manufacturing process and product; 
 
  An inspection has occurred within two years and the classification was voluntary action 
indicated (VAI) or official action indicated (OAI); or 
 
  A 510(k) is submitted to change the device to address failures or postmarket device 
malfunction reports. 
     
                                                           
16 Leveson, Nancy, Engineering a Safer World, Cambridge, MA, MIT Press, 2011. 
17 Under 21 CFR 7.3(m)(1), a class I recall is a situation in which there is a reasonable probability that the use of, or 
exposure to, a violative product will cause serious adverse health consequences or death. 
  33   
When a pre-clearance inspection is needed, FDA intends to perform a Level 2 Comprehensive 
Inspection per FDAs Compliance Program Guidance Manual 7382.845, Inspection of Medical 
Device Manufacturers.  This inspection will include review of your MDR procedures and 
processes. 
 
FDA finds that there is a substantial likelihood that the failure to comply with the Quality System 
regulation (21 CFR Part 820) for these products will potentially present a serious risk to human 
health.  Therefore, in accordance with section 513(f)(5) of the FD&C Act, FDA may withhold 
clearance of your 510(k) submission for infusion pumps covered by this guidance based on the 
results of a pre-clearance inspection. 
 
 
7. Postmarket Surveillance of Infusion Pumps 
 
Manufacturer Reporting Requirements 
Infusion pump manufacturers are subject to the MDR regulations at 21 CFR Part 803.  The 
MDR regulation (21 CFR 803.50) requires a manufacturer to submit a report to FDA 
whenever the manufacturer becomes aware of information, from any source, that reasonably 
suggests that its device: 
  May have caused or contributed to a death or serious injury; or  
  Has malfunctioned and the device or a similar device that the manufacturer markets 
would be likely to cause or contribute to a death or serious injury if the malfunction 
were to recur.   
The MDR regulations also include reporting and recordkeeping requirements for medical 
device user facilities (e.g., hospitals, nursing homes) and importers of medical devices, as well 
as device complaint recordkeeping requirements for medical device distributors. 
Manufacturers (defined in 21 CFR 803.3) are required to comply with 21 CFR Part 803, 
which includes the following: 
  Submit MDR reportable events involving their medical devices, as described in 21 CFR 
803.50 and 803.52; 
  Submit 5-day reports, as described in 21 CFR 803.53; 
  Submit supplemental reports, as described in 21 CFR 803.56; 
  Develop, maintain, and implement written procedures for the timely and effective 
identification, communication, and evaluation of events that may be subject to MDR 
requirements, and for a standardized review process for determining when an event 
meets the criteria for reporting under 21 CFR Part 803, as required by 21 CFR 803.17; 
  Conduct an investigation of each event and evaluate the cause of the event, as required 
by 21 CFR 803.50(b)(3), and 
  Establish and maintain MDR event files, clearly identify all MDR event files, and 
maintain them to facilitate timely access, as required by 21 CFR 803.18. 
  34   
The MDR report (FDA Form 3500A) must contain all the information described in 21 CFR 
803.52 that is known or reasonably known to the manufacturer.  Information reasonably 
known, under 21 CFR 803.50(b), includes any information that the manufacturer: 
  Can obtain by contacting a user facility, importer, or other initial reporter; 
  Is in the possession of; or 
  Can obtain by analysis, testing, or other evaluation of the device. 
The FDA Form 3500A, instructions for completing specific items on the form, and the coding 
manual can be found at:   
http://www.fda.gov/downloads/Safety/MedWatch/HowToReport/DownloadForms/UCM3870
02.pdf. 
For additional guidance on the MDR regulations and the reporting requirements, please refer 
to the FDAs Guidance, Medical Device Reporting for Manufacturers 
(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/uc
m094529.htm). 
 
 
Common Infusion Pump Reportability Questions from 
Manufacturers 
 
Do I need to submit an MDR report  If the information reasonably suggests that your 
for malfunctions that result in delay of  device may have caused or contributed to a death or 
drug therapy?   serious injury, or has malfunctioned and that the 
device or a similar device marketed by you would 
be likely to cause or contribute to a death or serious 
injury if the malfunction were to recur, then this is 
considered a reportable event.  21 CFR 803.3 and 
803.50. 
We have a fail-safe feature in our  The fact that you have a fail-safe feature does not 
infusion pumps.  Since we have this  eliminate your obligations under 21 CFR part 803.  
feature in our pumps, when there is a  You must develop, maintain, and implement 
device malfunction, would I have to  written procedures for the timely and effective 
submit an MDR report?  identification, communication, and evaluation of 
events that may be subject to MDR requirements, 
and for a standardized review process for 
determining when an event meets the criteria for 
reporting under 21 CFR Part 803, as required by 21 
CFR 803.17. 
  35   
  It is important to analyze, test, and evaluate the 
How much effort should a firm take to  device in order to conduct a thorough investigation 
obtain additional information and/or  into the root cause of the reported event and 
the device?    determine if device malfunction contributed to the 
  event. 21 CFR 803.50(b). 
 
If your report omits any required information, you 
must explain why this information was not 
provided and the steps taken to obtain this 
information. 21 CFR 803.52(f)(11)(iii). 
  The MDR report (FDA Form 3500A) must contain 
How much detail do I need to use to  all the information described in 21 CFR 803.52 that 
describe the event?   is known or reasonably known to the manufacturer, 
including, but not limited to: how the device was 
involved, nature of the problem, any required 
patient treatment, outcomes attributed to the 
adverse event, and any environmental conditions 
that may have influenced the event. 21 CFR 
803.52. 
 
 
 
  36