Your scenario ("a needle-based on body delivery system intended to deliver a medicinal product for which a defined delivery rate is not of clinical relevance (but the time or speed employed to deliver a discrete volume is based upon tolerability or convenience)") has been a point of controversy and evolving thinking within FDA over recent years.
You should consider what drug(s) your device is intended to deliver (i.e. it may be a combination product of some type), and the available pharmacokinetic data for those drugs to demonstrate safety and effectiveness with a varying flow rate.
Additionally ISO 11608-6:2022 would likely apply and it has additional considerations.
Bottom line is that the difference between an 'infuser' and an 'injector' is not always explicitly clear and is dependent upon the drugs being administered. I'd recommend assessing carefully; feel free to reach out to me directly to discuss further.
Regardless, this is a challenging space; best of luck!
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Jonathan Amaya-Hodges
Director, Technical Services
Suttons Creek, Inc.
United States
jamaya-hodges@suttonscreek.com------------------------------
Original Message:
Sent: 03-Apr-2024 02:57
From: Anonymous Member
Subject: infusion pump per CFR 880.5725
This message was posted by a user wishing to remain anonymous
Dear all,
This question is about the identification of infusion pump according to CFR 880.5725 and the FDA website "Infusion pumps", and use of terms "controlled manner" and "controlled amounts":
- CFR 880.5725 indicates that "An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner"
- FDA website "Infusion pumps" indicates that "An infusion pump is a medical device that delivers fluids, such as nutrients and medications, into a patient's body in controlled amounts.".
How should the terms "controlled manner" and "controlled amounts" be interpreted, do these relate with the capacity of the infusion pump to continuous deliver a medicinal product at a defined delivery rate which is of clinical relevance (e.g. clinical efficacy)?
If so, would you agree that a needle-based on body delivery system intended to deliver a medicinal product for which a defined delivery rate is not of clinical relevance (but the time or speed employed to deliver a discrete volume is based upon tolerability or convenience), is NOT considered an "infusion pump" per CFR 880.5725 ?
Thank you!