In this constantly changing world, it is important that your products keep up with the latest technology available. With medical devices now being in the form of wearables, long gone are the days when patients needed to be hooked up to a system to monitor their health. Continuously improving your product requires you to make changes, and some of these changes may require notifying the FDA in the form of supplemental reports, 510(k)s, etc...

1. 5 things to consider when making a change to an
existing medical device.
By: Nikita Angane
In this constantly changing world, it is important that your products keep up with the
latest technology available. With medical devices now being in the form of wearables, long gone
are the days when patients needed to be hooked up to a system to monitor their health.
Continuously improving your product requires you to make changes, and some of these
changes may require notifying the FDA in the form of supplemental reports, 510(k)s, etc.
When making a change to an existing device, below are the five categories that you must
consider its impact on.1
1. Product Label
2. Change to technology/engineering.
3. Software changes
4. Material changes and
5. Change made to improve the safety and efficacy of the device.
Impact on the product label could be in the form of changes to indications for use,
changing it from a single-use device to a reusable device, change in the instructions for
use based on post-market feedback, etc.
Changes to the technology may impact its mode of operation or require changes in the
sterilization processes if applicable. Technology changes also raise additional questions
about the safety and efficacy of the device and the changed product may no longer be
substantially equivalent to its predicate if a 510(k) clearance was obtained.
Software changes are one of the easiest to make however, sometimes, a small change
may make the unchanged sections of the software vulnerable to additional risks.
Software bug fixes are common, however, the change must be evaluated diligently to
assess whether it compromises the cybersecurity of the system or for its impact on
clinical functionality such as its ability to make clinical decisions, etc.
Material changes have animpact on devices that directly or indirectly are in contact with
body tissues or fluids. This in turn raises concerns on the biocompatibility of the
product.
The impact of all these factors must be considered within the realm of risk assessment
and this will allow for making aninformed decision about whether notification to the
regulatory authority is required. We have seen companies often miss this step and get
into trouble during an audit for not notifying the FDA when a supplementary submission
was required.

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1 FDA (Oct 2017) DecidingWhen to Submit a 510(k) for a Change to an ExistingDevice retrieved on 02/23/2021
from https://www.fda.gov/media/99812/download