Regulatory Open Forum

​I'm looking for experience with submitting a Special 510(k) in cases where there is also a desire to market an existing device solely for pediatric use.

The current indications for use do not specify any age group, and the nature of the disease which is treated by the device is such that it is usually detected in early childhood if not at birth and life expectancy is limited.

The manufacturer wishes to market a version of the device which only includes the smaller attachments suitable for treating neonates and children.

At the same time, they want to modify the software, which of itself could trigger the need for a Special 510(k).

Based on my reading of the Guidance documents, limiting the target patient population by age group would not require a 510(k), because it is not considered a change in indications for use. However, changing the functionality of the software could trigger the need for a 510(k).

Can a Special 510(k) be submitted which limits the target age group to one which was not excluded in the original 510(k) predicate?

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Jean Bigoney PHD, RAC
Managing Member
Nu Device Consulting LLC
Murphy NC
United States
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Original Message------

​I'm looking for experience with submitting a Special 510(k) in cases where there is also a desire to market an existing device solely for pediatric use.

The current indications for use do not specify any age group, and the nature of the disease which is treated by the device is such that it is usually detected in early childhood if not at birth and life expectancy is limited.

The manufacturer wishes to market a version of the device which only includes the smaller attachments suitable for treating neonates and children.

At the same time, they want to modify the software, which of itself could trigger the need for a Special 510(k).

Based on my reading of the Guidance documents, limiting the target patient population by age group would not require a 510(k), because it is not considered a change in indications for use. However, changing the functionality of the software could trigger the need for a 510(k).

Can a Special 510(k) be submitted which limits the target age group to one which was not excluded in the original 510(k) predicate?

------------------------------
Jean Bigoney PHD, RAC
Managing Member
Nu Device Consulting LLC
Murphy NC
United States
------------------------------

Changing your patient population from general to specific often does require a new 510(k); changing to specify neonates is likely to cause concern.
FDA/CDRH has a guidance on this type of change (link).
Good luck!

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Andrea Chamblee Esq., RAC, FRAPS

This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and do not necessarily represent the official views of the agency or the United States. Consult the Agency for an official position.

Silver Spring MD
United States
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Original Message:
Sent: 29-Oct-2017 17:58
From: Jean Bigoney
Subject: Special 510(k) with simultaneous limit to patient population

​I'm looking for experience with submitting a Special 510(k) in cases where there is also a desire to market an existing device solely for pediatric use.

The current indications for use do not specify any age group, and the nature of the disease which is treated by the device is such that it is usually detected in early childhood if not at birth and life expectancy is limited.

The manufacturer wishes to market a version of the device which only includes the smaller attachments suitable for treating neonates and children.

At the same time, they want to modify the software, which of itself could trigger the need for a Special 510(k).

Based on my reading of the Guidance documents, limiting the target patient population by age group would not require a 510(k), because it is not considered a change in indications for use. However, changing the functionality of the software could trigger the need for a 510(k).

Can a Special 510(k) be submitted which limits the target age group to one which was not excluded in the original 510(k) predicate?

------------------------------
Jean Bigoney PHD, RAC
Managing Member
Nu Device Consulting LLC
Murphy NC
United States
------------------------------