Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

I'd recommend looking them up in the Medical Device Registration database, rather than the Premarket Notification / 510(k) database. That way you can see all products and what their class is.
Original Message:
Sent: 10-Apr-2020 15:01
From: Dawnel Scott
Subject: software controlled pill dispenser

Hi--I've been researching the regulatory status of automatic pill dispensers. There are several on the market and I can find only one 510(k) for a device that appear to no longer be in use. Are these Class I or Class II?

Thanks for any input.

Thank you for your assistance.

------------------------------
Dawnel Scott
RA/QA
Livermore CA
United States
------------------------------

Original Message:
Sent: 13-Apr-2020 08:08
From: Anonymous Member
Subject: software controlled pill dispenser

This message was posted by a user wishing to remain anonymous

I'd recommend looking them up in the Medical Device Registration database, rather than the Premarket Notification / 510(k) database. That way you can see all products and what their class is.
Original Message:
Sent: 10-Apr-2020 15:01
From: Dawnel Scott
Subject: software controlled pill dispenser

Hi--I've been researching the regulatory status of automatic pill dispensers. There are several on the market and I can find only one 510(k) for a device that appear to no longer be in use. Are these Class I or Class II?

Thanks for any input.

Hi Dawnel

Classification depends on what you day your intended use/indications for use are, and technological features as well.   If you exceed the Class I classification description, you may end up Class II, DeNovo, or even oddly Class I but needing a 510(k). 

Software controlled devices are not usually exempt from  design controls.  PM me at centaurconsultingllc@gmail.com if you like, have one I worked on recentky.

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 13-Apr-2020 20:12
From: Dawnel Scott
Subject: software controlled pill dispenser

Thank you for your assistance.

------------------------------
Dawnel Scott
RA/QA
Livermore CA
United States

Original Message:
Sent: 13-Apr-2020 08:08
From: Anonymous Member
Subject: software controlled pill dispenser

This message was posted by a user wishing to remain anonymous

I'd recommend looking them up in the Medical Device Registration database, rather than the Premarket Notification / 510(k) database. That way you can see all products and what their class is.
Original Message:
Sent: 10-Apr-2020 15:01
From: Dawnel Scott
Subject: software controlled pill dispenser

Hi--I've been researching the regulatory status of automatic pill dispensers. There are several on the market and I can find only one 510(k) for a device that appear to no longer be in use. Are these Class I or Class II?

Thanks for any input.

I think this is the product classification you are looking for. 510(k) and GMP exempt.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=2834

------------------------------
Adam Atherton
Farragut TN
United States
------------------------------

Original Message:
Sent: 10-Apr-2020 15:01
From: Dawnel Scott
Subject: software controlled pill dispenser

Hi--I've been researching the regulatory status of automatic pill dispensers. There are several on the market and I can find only one 510(k) for a device that appear to no longer be in use. Are these Class I or Class II?

Thanks for any input.