FDA Guidance On Infusion Pumps - Overview - RegDesk

2022/6/10 13:53 FDA Guidance on Infusion Pumps: Overview | RegDesk
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FDA Guidance on Infusion Pumps:

Overview
Aug 1, 2021
The Food and Drug Administration (FDA or the Agency), the US regulating
authority in the sphere of healthcare products, continuously develops and
publishes guidance documents dedicated to various medical devices. In these
documents, the FDA addresses the most important issues related to the
applicable regulatory framework and provides additional clarifications and
recommendations to be considered by the medical device manufacturers and
other parties involved.
https://www.regdesk.co/fda-guidance-on-infusion-pumps-overview/ 1/9
Table of Contents
Contents 
1. Table of Contents
2. Regulatory Background
3. Policy in Detail
4. Sources:
5. How Can RegDesk Help?
It is important to mention that due to the legal nature of guidance documents

issued by the FDA, the provisions contained therein are non-binding, and an
alternative approach could be applied, provided such an approach complies with
the current legislation and has been agreed with the Agency before being
implemented.
There are several guidance documents and policies dedicated to infusion pumps.
For instance, the regulatory matters related to these devices are addressed in the
appropriate FDA Enforcement policy or the FDA Emergency use authorization
(EUA), describing the special temporary and extraordinary measures introduced
by the authority in order to expand and ensure the availability of such devices
during the public health emergency associated with the outbreak of the
Coronavirus Disease 2019 (COVID-19) caused by the virus “SARS-CoV-2” or the
“novel coronavirus.” At the same time, the basics of the applicable regulatory
framework for infusion pumps are described in the FDA guidance on infusion
pumps’ total product life cycle published by the authority earlier in December
2014.
Regulatory Background
The present guidance is intended to provide medical device manufacturers with
additional recommendations to be taken into consideration when preparing
premarket submissions for infusion pumps. Additionally, the document
highlights specific aspects to be addressed throughout the whole product life
cycle.
Infusion pumps are medical devices intended for use in a healthcare facility to

pump fluids into a patient in a controlled manner, where the term “fluids” stands
for FDA approved drugs and licensed biological products. It is also important to
mention that the scope of the present guidance covers infusion pumps intended
to be used by laypersons outside healthcare facilities under the supervision of a
healthcare professional. The applicable regulatory framework for infusion pumps
is based on regulation 21 CFR 880.5725. The Agency expects that the
recommendations provided in the guidance will improve the overall quality of
medical devices placed on the market and reduce the number of recalls and
incidents associated thereto. The regulating authority also describes the
approach to be applied with regard to risks associated with the use of such
devices and how they should be mitigated.
On the basis of the evaluation of numerous medical devices, as well as incidents

associated thereto, the Agency states that numerous incidents could be
prevented by improving design verification and validation processes for these
devices. According to the information available to the FDA, in most cases the
issues associated with infusion pumps 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,
• Over infusion or under infusion.
It is also important to mention that for some incidents, it was impossible for the
manufacturer to determine precisely the nature of the error that occurred.
However, further investigation demonstrated that such issues could also be
prevented by making changes to the design processes. Hence, as mentioned, the
main purpose of this guidance is to assist medical device manufacturers in
improving the overall quality of medical devices placed on the market and, in this
way, reduce the incidents associated thereto.
According to the document, its scope covers Class II medical devices falling
within the scope of 21 CFR 880.5725. The authority mentions that the provisions of
this guidance will also be applicable for all new devices covered by the
aforementioned regulation if such devices will be created in the future.
The FDA additionally emphasizes that infusion pumps submitted as part of Class

III system are subject to the premarket approval application (PMA) pathway. Since
the present document mostly deals with regulatory matters related to the
premarket notification 510(k) framework, some of its provisions will not be
applicable for the premarket approval application as the scope of the latter
exceeds the requirements under 510(k). For instance, the PMA framework
provides more detailed requirements in terms of hazard identification due to the
higher risks associated with Class III medical devices.
Policy in Detail
First, the FDA provides the definition of an infusion pump as prescribed by the
applicable legislation, and also highlights the most important aspects associated
with these devices. For instance, an infusion pump could be powered electrically
or mechanically and should contain special controls intended to identify failures
and notify healthcare professionals (alarm systems).
According to the guidance, the infusion pump system contains the following
elements:
• 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).
The Agency additionally emphasizes that if the infusion pump in question will be
supplied or recommended for use with additional disposable devices, such
devices should be clearly identified and be approved for marketing and use.
However, for the purpose of this guidance, such devices will be considered to be
part of the infusion pump system and treated accordingly. In such a case, the
safety and effectiveness would be evaluated for the infusion pump system in
general.
In certain cases, an infusion pump together with the product it is intended to

administer could fall within the scope of the definition of a combination product.
Consequently, the relevant regulations for combination products should be
applied. Thus, the medical device manufacturer will have to ensure compliance
with the applicable regulatory requirements combination products should meet
and also contact the Office of Combination Products (OCP) if any issues arise.
In summary, the present FDA guidance on infusion pumps provides an overview

of the applicable regulatory framework and highlights the most important
aspects to be considered by the medical device manufacturers intended to place
their products on the US market. The document also outlines certain device-
specific matters associated with some of the infusion pumps due to their design
and functionality and describes the way this will impact the regulatory
procedures associated with such devices in accordance with the current
legislation.
Sources:
https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/infusion-pumps-total-product-life-cycle
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2022/6/10 13:53 FDA Guidance on Infusion Pumps: Overview | RegDesk

Home / RegDesk Blog / FDA / FDA Guidance on Infusion Pumps: Overview

FDA Guidance on Infusion Pumps:

5. How Can RegDesk Help?

It is important to mention that due to the legal nature of guidance documents

Infusion pumps are medical devices intended for use in a healthcare facility to

On the basis of the evaluation of numerous medical devices, as well as incidents

• Software error messages,

The FDA additionally emphasizes that infusion pumps submitted as part of Class

• Components and accessories (e.g., power cord, wireless controller);

In certain cases, an infusion pump together with the product it is intended to

In summary, the present FDA guidance on infusion pumps provides an overview

How Can RegDesk Help?

Want to know more about our

First name Last name

Work e-mail address

Description of regulatory needs

Take The First Step Towards Medical Devices Registrations

Work e-mail address

Australia and Oceania (92)

Case Study (19)

medical devices (442)

Medical Device (367)

united states (174)

guidance RegDesk (152)

RegDesk, Solutions Resources Company

| +1 267 607 3375 Regulatory HTML

© 2022 RegDesk, Inc. All rights reserved

Work e-mail address*

Work e-mail address

First name* Last name Work e-mail address*

First name Last name Work e-mail address

Company name* Description of regulatory needs

Company name Description of regulatory needs

Try Us for Free Now!

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