Thank you, Richard and Ted!
To summarize, explicit indication for use with a pediatric population may be expected by the FDA in a 510(k), but the FDA is more concerned with devices where the use with a pediatric population could introduce a significant risk.
Therefore, within the context of pediatric vs adult populations, a device manufacturer can typically market a 510(k) cleared device without discrimination for age of target population so long as it doesn't introduce unreasonable risk to the pediatric population.
Is this an accurate understanding of your experiences?
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Ian Boland
Regulatory Affairs Specialist
NJ
United States
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Original Message:
Sent: 01-Feb-2023 09:38
From: Ted Heise
Subject: Identifying Device Cleared for Pediatric Population
We are on the same page, Richard, as usual.
I was not disagreeing with you so much as qualifying it a bit. And taking an opportunity for a mild rant too.
:)
Original Message:
Sent: 2/1/2023 9:36:00 AM
From: Richard Vincins
Subject: RE: Identifying Device Cleared for Pediatric Population
Oh Ted, does not mean I would say this absolutely needs to be done. What I was referring to about inconsistency is having a place in the regulations or having a way regulators can clearly indicate age range of product use ... if needed. Completely agree setting the age of devices can be quite limiting, but at the same time I think there are some devices which needs to be specified. That was what I was referring is having a way to indicate whether a device should clearly indicate paediatric populations or not or specify an age range. As example, it is already known some implants are only intended or should only be intended for adult populations.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 01-Feb-2023 08:16
From: Ted Heise
Subject: Identifying Device Cleared for Pediatric Population
Richard, I'm not in 100% agreement that it's a good thing to be highly specific about populations in indications for use. In my experience, doing so has the unfortunate consequence of creating off label use. In many cases, general tools (e.g., catheters) may have utility in pediatrics but not generate enough revenue for collection of the data that may be requested by regulators to support that specific use.
I think all of us would like to see data that supports all intended uses, but when the process becomes overly complex/burdensome the product availability can suffer. It's a bit like humanitarian device issues.
It's a tough topic, to be sure.
Best regards,
Ted
Original Message:
Sent: 2/1/2023 6:17:00 AM
From: Richard Vincins
Subject: RE: Identifying Device Cleared for Pediatric Population
Hello Ian,
Unfortunately this is one of the fallacies and inconsistencies within the US regulatory system for medical devices (assume talking about 510(k)). The FDA has gotten better in the last 10 years about including patient age range in the indications for use/intended use or making clear statements like, 'adult population' which is assumed 21 years and older (defined by the FD&C Act). To answer your question, yes you will need to search through the 510(k) Summary or the Intended Use/Indications for Use statement to understand if this is clearly specified. I have spoken with some reviewers and investigators over the years which the general stance is as you said: if not specified it is assumed only cleared for adult population. As said before, higher risk devices and implants the US FDA has gotten more detailed in these type of products to clearly identify if can be used in a paediatric population or not.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 31-Jan-2023 12:05
From: Ian Boland
Subject: Identifying Device Cleared for Pediatric Population
If a device is cleared in the US for pediatric use, is that information always included in the Indications for Use portion of a 510(k) summary or is it possible to have it buried in the equivalence table under target population or somewhere else? Phrased a different way, my question is if a device's Indications for Use fail to mention any age range (e.g.: "device is intended to perform function X in population age Y and above"), is it assumed that the device is only cleared for the adult population?
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Ian Boland
Regulatory Affairs Specialist
NJ
United States
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