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If a manufacturer is interested to get a clearance for a labeling change from Rx to OTC can this be done through a special 510(k)? This is the only change that is being done to the device which was cleared earlier by the FDA for home use and there are absolutely no design changes that are being done to the device.  To be able to support the OTC the manufacturer is working on Human factors validation study.

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Sourav Patnaik
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Hello Sourav

This is an indications change (patient population) and would  be a Traditional 510(k),  in my opinion.

For home use, if this device is medical electrical equipment, you will need to show you meet EMC limits for home use as defined  in the 4th edition, and that you meet requirements  of  IEC 60601-1-11.  If this is a wireless RF device, you will need to consider if your coexistence testing considered coexistence  with emitters or other electronic  products or devices used in a home environment  (microwave  ovenss, etc).

Good luck.

Ginger

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Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
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Original Message:
Sent: 14-May-2020 03:45
From: Sourav Patnaik
Subject: Special 510(k)

If a manufacturer is interested to get a clearance for a labeling change from Rx to OTC can this be done through a special 510(k)? This is the only change that is being done to the device which was cleared earlier by the FDA for home use and there are absolutely no design changes that are being done to the device.  To be able to support the OTC the manufacturer is working on Human factors validation study.

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Sourav Patnaik
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​Hi Sourav,
This sounds very similar to a project I worked on back in 2004, with the only change being from Rx to over-the-counter. Although it's technically not an indication change since you already have clearance for home use, FDA does handle this as a labeling change that wouldn't be eligible for Special 510(k).  Human factors are very important. Do you have any postmarket data on home use by laypeople? That may be helpful as well.

Although my project went to panel and had a good discussion about all the issues about going OTC, unfortunately the transcript is no longer available. Here's the 510(k) listing: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K040904

Note: although this one was filed and cleared as a 510(k), FDA later called for PMAs of this preamendments class III device. Therefore, it is possible to change to OTC on a 510(k) vs. a PMA, but not for defibrillators anymore.

Best wishes for your project!


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Teresa Skarr RAC
Distinguished RA Advisor
Santa Rosa, CA
United States
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Original Message:
Sent: 14-May-2020 03:45
From: Sourav Patnaik
Subject: Special 510(k)

If a manufacturer is interested to get a clearance for a labeling change from Rx to OTC can this be done through a special 510(k)? This is the only change that is being done to the device which was cleared earlier by the FDA for home use and there are absolutely no design changes that are being done to the device.  To be able to support the OTC the manufacturer is working on Human factors validation study.

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Sourav Patnaik
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