Regulatory Open Forum

Hi RAPS forum members,

How can we find out the number of digital wearable devices that have received clearance or approval from the US FDA as a 510K or PMA submission in the last 5 years ?

Any guidance for getting this information is appreciated.

Thanks,

Gopikrishna Panicker
Mumbai, Maharashtra,
India

------------------------------
Gopikrishna Panicker
Mumbai
India
------------------------------

If you know the product codes I believe its possible to search explicitly for them on the FDA 510(k) website

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani
------------------------------

Original Message:
Sent: 17-Aug-2022 10:33
From: Gopikrishna Panicker
Subject: Wearables with FDA Approval or Clearance

Hi RAPS forum members,

How can we find out the number of digital wearable devices that have received clearance or approval from the US FDA as a 510K or PMA submission in the last 5 years ?

Any guidance for getting this information is appreciated.

Thanks,

Gopikrishna Panicker
Mumbai, Maharashtra,
India

------------------------------
Gopikrishna Panicker
Mumbai
India
------------------------------

Thank you very much, Edward. That is helpful.

I was trying to get the list of all the wearables that have been cleared/approved for cardiology and realized that no such list is available. Is it possible to get the names of all wearable devices through any search terms or keywords on the FDA 510(k) website?

Thanks,
Gopikrishna Panicker



------------------------------
Gopikrishna Panicker
Mumbai
India
------------------------------

Original Message:
Sent: 18-Aug-2022 09:05
From: Ed Panek
Subject: Wearables with FDA Approval or Clearance

If you know the product codes I believe its possible to search explicitly for them on the FDA 510(k) website

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani

Original Message:
Sent: 17-Aug-2022 10:33
From: Gopikrishna Panicker
Subject: Wearables with FDA Approval or Clearance

Hi RAPS forum members,

How can we find out the number of digital wearable devices that have received clearance or approval from the US FDA as a 510K or PMA submission in the last 5 years ?

Any guidance for getting this information is appreciated.

Thanks,

Gopikrishna Panicker
Mumbai, Maharashtra,
India

------------------------------
Gopikrishna Panicker
Mumbai
India
------------------------------

Yes, and it's the same pathway that Edward mentioned.  You can use the FDA 510(k) database to search, but the search is limited by the criteria that their "advanced search" can filter on, so you have to construct your search around those fields.

Since I know that Apple has a cleared biowearable in the cardiology space (and I suspect you may have knew this, too - as, well, most that follow biowearables know this one) - you can search for Apple as an applicant in the 510(k) database. Then you can see that the last three 510(k) clearances they have are linked to either product code "QDA" or "QDB".  There, now you know you can go back to the database and search for those product codes.  However, this might not be the only relevant product codes and you may need to do some other digging to determine that either using the FDA databases, or using outside sources that can give you hints about other cleared products in the space that you can then use to query on FDA's website to see if other product codes are relevant.

------------------------------
Katherine Doll Kanne
Principal Regulatory Affairs Specialist
Saint Paul MN
United States
------------------------------

Original Message:
Sent: 19-Aug-2022 08:45
From: Gopikrishna Panicker
Subject: Wearables with FDA Approval or Clearance

Thank you very much, Edward. That is helpful.

I was trying to get the list of all the wearables that have been cleared/approved for cardiology and realized that no such list is available. Is it possible to get the names of all wearable devices through any search terms or keywords on the FDA 510(k) website?

Thanks,
Gopikrishna Panicker



------------------------------
Gopikrishna Panicker
Mumbai
India

Original Message:
Sent: 18-Aug-2022 09:05
From: Ed Panek
Subject: Wearables with FDA Approval or Clearance

If you know the product codes I believe its possible to search explicitly for them on the FDA 510(k) website

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani

Original Message:
Sent: 17-Aug-2022 10:33
From: Gopikrishna Panicker
Subject: Wearables with FDA Approval or Clearance

Hi RAPS forum members,

How can we find out the number of digital wearable devices that have received clearance or approval from the US FDA as a 510K or PMA submission in the last 5 years ?

Any guidance for getting this information is appreciated.

Thanks,

Gopikrishna Panicker
Mumbai, Maharashtra,
India

------------------------------
Gopikrishna Panicker
Mumbai
India
------------------------------

Original Message:
Sent: 8/19/2022 8:58:00 AM
From: Katherine Doll Kanne
Subject: RE: Wearables with FDA Approval or Clearance

Yes, and it's the same pathway that Edward mentioned.  You can use the FDA 510(k) database to search, but the search is limited by the criteria that their "advanced search" can filter on, so you have to construct your search around those fields.

Since I know that Apple has a cleared biowearable in the cardiology space (and I suspect you may have knew this, too - as, well, most that follow biowearables know this one) - you can search for Apple as an applicant in the 510(k) database. Then you can see that the last three 510(k) clearances they have are linked to either product code "QDA" or "QDB".  There, now you know you can go back to the database and search for those product codes.  However, this might not be the only relevant product codes and you may need to do some other digging to determine that either using the FDA databases, or using outside sources that can give you hints about other cleared products in the space that you can then use to query on FDA's website to see if other product codes are relevant.

------------------------------
Katherine Doll Kanne
Principal Regulatory Affairs Specialist
Saint Paul MN
United States
------------------------------

Original Message:
Sent: 19-Aug-2022 08:45
From: Gopikrishna Panicker
Subject: Wearables with FDA Approval or Clearance

Thank you very much, Edward. That is helpful.

I was trying to get the list of all the wearables that have been cleared/approved for cardiology and realized that no such list is available. Is it possible to get the names of all wearable devices through any search terms or keywords on the FDA 510(k) website?

Thanks,
Gopikrishna Panicker



------------------------------
Gopikrishna Panicker
Mumbai
India

Original Message:
Sent: 18-Aug-2022 09:05
From: Ed Panek
Subject: Wearables with FDA Approval or Clearance

If you know the product codes I believe its possible to search explicitly for them on the FDA 510(k) website

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani

Original Message:
Sent: 17-Aug-2022 10:33
From: Gopikrishna Panicker
Subject: Wearables with FDA Approval or Clearance

Hi RAPS forum members,

How can we find out the number of digital wearable devices that have received clearance or approval from the US FDA as a 510K or PMA submission in the last 5 years ?

Any guidance for getting this information is appreciated.

Thanks,

Gopikrishna Panicker
Mumbai, Maharashtra,
India

------------------------------
Gopikrishna Panicker
Mumbai
India
------------------------------

Good to know that, Ted. Thank you.

------------------------------
Gopikrishna Panicker
Mumbai
India
------------------------------

Original Message:
Sent: 19-Aug-2022 09:13
From: Ted Heise
Subject: Wearables with FDA Approval or Clearance

 

 

Good advice, Katherine.  I also find the classification name database to be useful in doing this type of research.

 

Best regards,

 

Ted

 

 

 

Original Message:
Sent: 8/19/2022 8:58:00 AM
From: Katherine Doll Kanne
Subject: RE: Wearables with FDA Approval or Clearance

Yes, and it's the same pathway that Edward mentioned.  You can use the FDA 510(k) database to search, but the search is limited by the criteria that their "advanced search" can filter on, so you have to construct your search around those fields.

Since I know that Apple has a cleared biowearable in the cardiology space (and I suspect you may have knew this, too - as, well, most that follow biowearables know this one) - you can search for Apple as an applicant in the 510(k) database. Then you can see that the last three 510(k) clearances they have are linked to either product code "QDA" or "QDB".  There, now you know you can go back to the database and search for those product codes.  However, this might not be the only relevant product codes and you may need to do some other digging to determine that either using the FDA databases, or using outside sources that can give you hints about other cleared products in the space that you can then use to query on FDA's website to see if other product codes are relevant.

------------------------------
Katherine Doll Kanne
Principal Regulatory Affairs Specialist
Saint Paul MN
United States

Original Message:
Sent: 19-Aug-2022 08:45
From: Gopikrishna Panicker
Subject: Wearables with FDA Approval or Clearance

Thank you very much, Edward. That is helpful.

I was trying to get the list of all the wearables that have been cleared/approved for cardiology and realized that no such list is available. Is it possible to get the names of all wearable devices through any search terms or keywords on the FDA 510(k) website?

Thanks,
Gopikrishna Panicker



------------------------------
Gopikrishna Panicker
Mumbai
India

Original Message:
Sent: 18-Aug-2022 09:05
From: Ed Panek
Subject: Wearables with FDA Approval or Clearance

If you know the product codes I believe its possible to search explicitly for them on the FDA 510(k) website

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani

Original Message:
Sent: 17-Aug-2022 10:33
From: Gopikrishna Panicker
Subject: Wearables with FDA Approval or Clearance

Hi RAPS forum members,

How can we find out the number of digital wearable devices that have received clearance or approval from the US FDA as a 510K or PMA submission in the last 5 years ?

Any guidance for getting this information is appreciated.

Thanks,

Gopikrishna Panicker
Mumbai, Maharashtra,
India

------------------------------
Gopikrishna Panicker
Mumbai
India
------------------------------

Thank you very much, Katherine. This is very useful advice. I will take your advice and do a combination of applicant/product code searches and searches on Google Scholar to get the details of all approved wearables in cardiology.

------------------------------
Gopikrishna Panicker
Mumbai
India
------------------------------

Original Message:
Sent: 19-Aug-2022 08:57
From: Katherine Doll Kanne
Subject: Wearables with FDA Approval or Clearance

Yes, and it's the same pathway that Edward mentioned.  You can use the FDA 510(k) database to search, but the search is limited by the criteria that their "advanced search" can filter on, so you have to construct your search around those fields.

Since I know that Apple has a cleared biowearable in the cardiology space (and I suspect you may have knew this, too - as, well, most that follow biowearables know this one) - you can search for Apple as an applicant in the 510(k) database. Then you can see that the last three 510(k) clearances they have are linked to either product code "QDA" or "QDB".  There, now you know you can go back to the database and search for those product codes.  However, this might not be the only relevant product codes and you may need to do some other digging to determine that either using the FDA databases, or using outside sources that can give you hints about other cleared products in the space that you can then use to query on FDA's website to see if other product codes are relevant.

------------------------------
Katherine Doll Kanne
Principal Regulatory Affairs Specialist
Saint Paul MN
United States

Original Message:
Sent: 19-Aug-2022 08:45
From: Gopikrishna Panicker
Subject: Wearables with FDA Approval or Clearance

Thank you very much, Edward. That is helpful.

I was trying to get the list of all the wearables that have been cleared/approved for cardiology and realized that no such list is available. Is it possible to get the names of all wearable devices through any search terms or keywords on the FDA 510(k) website?

Thanks,
Gopikrishna Panicker



------------------------------
Gopikrishna Panicker
Mumbai
India

Original Message:
Sent: 18-Aug-2022 09:05
From: Ed Panek
Subject: Wearables with FDA Approval or Clearance

If you know the product codes I believe its possible to search explicitly for them on the FDA 510(k) website

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani

Original Message:
Sent: 17-Aug-2022 10:33
From: Gopikrishna Panicker
Subject: Wearables with FDA Approval or Clearance

Hi RAPS forum members,

How can we find out the number of digital wearable devices that have received clearance or approval from the US FDA as a 510K or PMA submission in the last 5 years ?

Any guidance for getting this information is appreciated.

Thanks,

Gopikrishna Panicker
Mumbai, Maharashtra,
India

------------------------------
Gopikrishna Panicker
Mumbai
India
------------------------------