Regulatory Open Forum

Hi Anon,

I expect you will need to look carefully at how the bags are used.  In clause 5.3.3 (the section on medical devices with multiple contacts), ISO 10993-1:2018 states:

If a material or medical device can be placed in more than one duration category, the more rigorous testing and/or evaluation considerations shall apply. With expected or intended multiple exposures to a device, the decision into which category a medical device is placed shall take into account the potential cumulative effect, bearing in mind the period of time over which these exposures occur.

So I would advise developing an assessment of not only the durations but how many times an individual patient might be exposed to fluids delivered from your bags.  You will probably need to consider the range of possible uses and select the worst case (unless you have a *really* solid rationale for basing it on a shorter exposure).  If the cumulative exposure is over 30 days, you should treat it as a long term contact duration device.

One additional comment is that repeat exposure like this can potentially be higher risk, in that a new device (with a fresh reservoir of potential leachables) is used each time, and the cumulative effect is likely to be greater than from a single bag used repeatedly (I doubt this actually happens in practice, just using it as a theoretical scenario for illustration), or for a single extended time.

MED Institute has lots of experience in this area.  Feel free to contact me off list if you'd like to discuss in more depth.

Best regards,

Ted

--

Theodore (Ted) Heise, PHD, RAC

Vice President Regulatory and Clinical Services

MED Institute Inc.

1330 Win Hentschel Blvd.

West Lafayette, IN  47906-4149 USA

765.463.1633 ext. 4444

http://medinstitute.com

theise@medinstitute.com

Hi Anon,

I agree that Ted's answer was excellent and consistent with the interpretation in the ISO 10993-1 standard.  However you asked as to the potential FDA position.  I am assuming that this is IV bag provided empty and is regulated as a medical device and not provided filled and regulated a Drug combination product.  If the latter, the therapy and or dosing for the drug will establish the potential individual patient exposure.

So, I approach this from a practical perspective, so as not to reinvent the wheel.  As a medical device, from a practical perspective, if you state it is permanent contact, CDRH will agree.  However FDA's position is to determine if you have established that your device is substantially equivalent (SE) to a predicate, so it is more about historical precedent for this route to market.  If you look at the clearance information on-line for Intravascular infusion sets (FPA) and for IV bags (KPE), where it is provided you mostly see statements regarding prolonged contact and/or testing referenced that would be consistent with that designation. For FDA and the USA, this is the criteria for FDA to determine if the testing is adequate to establish SE.

I hope that is helpful.

Lee Leichter

President

P/L Biomedical

10882 Stonington Avenue

Fort Myers, FL 33913 USA

Office: +1-239-244-1448

Cell: +1-239-994-6488

Email: leichter@plbiomedical.com