Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

​​Hello Regulatory Colleagues,

Is it possible to file a 510(k) with multiple predicates?  If yes, how may this be accomplished?

Thank you.

Hi, Yes - there can be more than one predicate device in the 510(k). The Substantial equivalence section must include detailed information on the comparison of characteristics of each of the predicate devices to that of the device in question.

More information on the MDR rates using multiple predicate devices can be found here:
Medical Device Reporting (MDR) Rate in 510(k) Cleared Devices Using Multiple Predicates

Best,
Deepa



------------------------------
DEEPA R. GODHIYA
Marlborough MA
United States
------------------------------

Original Message:
Sent: 20-Apr-2018 17:17
From: Anonymous Member
Subject: 510(k) with Multiple Predicates

This message was posted by a user wishing to remain anonymous

​​Hello Regulatory Colleagues,

Is it possible to file a 510(k) with multiple predicates?  If yes, how may this be accomplished?

Thank you.

This message was posted by a user wishing to remain anonymous

​Hello,

Just from recent experience, we were advised by FDA in a 510k Pre-Sub to only directly use one predicate. We had originally submitted 2 predicates, but had to scale back to one, and use the other as supporting information within the 510k.
Original Message:
Sent: 23-Apr-2018 12:05
From: DEEPA GODHIYA
Subject: 510(k) with Multiple Predicates

Hi, Yes - there can be more than one predicate device in the 510(k). The Substantial equivalence section must include detailed information on the comparison of characteristics of each of the predicate devices to that of the device in question.

More information on the MDR rates using multiple predicate devices can be found here:
Medical Device Reporting (MDR) Rate in 510(k) Cleared Devices Using Multiple Predicates

Best,
Deepa



------------------------------
DEEPA R. GODHIYA
Marlborough MA
United States

Original Message:
Sent: 20-Apr-2018 17:17
From: Anonymous Member
Subject: 510(k) with Multiple Predicates

This message was posted by a user wishing to remain anonymous

​​Hello Regulatory Colleagues,

Is it possible to file a 510(k) with multiple predicates?  If yes, how may this be accomplished?

Thank you.

The following FDA guidance refers to use of a single "primary predicate", but then discusses inclusion of other "reference devices" in your submission:  https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm284443.pdf

------------------------------
Lauren Kamer RAC
Director of Regulatory
United States
------------------------------

Original Message:
Sent: 24-Apr-2018 05:37
From: Anonymous Member
Subject: 510(k) with Multiple Predicates

This message was posted by a user wishing to remain anonymous

​Hello,

Just from recent experience, we were advised by FDA in a 510k Pre-Sub to only directly use one predicate. We had originally submitted 2 predicates, but had to scale back to one, and use the other as supporting information within the 510k.
Original Message:
Sent: 23-Apr-2018 12:05
From: DEEPA GODHIYA
Subject: 510(k) with Multiple Predicates

Hi, Yes - there can be more than one predicate device in the 510(k). The Substantial equivalence section must include detailed information on the comparison of characteristics of each of the predicate devices to that of the device in question.

More information on the MDR rates using multiple predicate devices can be found here:
Medical Device Reporting (MDR) Rate in 510(k) Cleared Devices Using Multiple Predicates

Best,
Deepa



------------------------------
DEEPA R. GODHIYA
Marlborough MA
United States

Original Message:
Sent: 20-Apr-2018 17:17
From: Anonymous Member
Subject: 510(k) with Multiple Predicates

This message was posted by a user wishing to remain anonymous

​​Hello Regulatory Colleagues,

Is it possible to file a 510(k) with multiple predicates?  If yes, how may this be accomplished?

Thank you.

I agree with Lauren.  My experience has always been one primary predicate device and then 1 or more "reference devices" for specific features or other technologies.  The guidance in the link above has really good and clear examples of when and how to use reference devices.

FDA is moving away from multiple "predicate" devices even though their above guidance allows it and explains how to properly use them.  Avoid multiple predicates as it will almost certainly increase your review time and additional information requests.

Good luck!

------------------------------
Daniel Petersen
RA Specialist
Draper UT
United States
------------------------------

Original Message:
Sent: 25-Apr-2018 07:15
From: Lauren Kamer
Subject: 510(k) with Multiple Predicates

The following FDA guidance refers to use of a single "primary predicate", but then discusses inclusion of other "reference devices" in your submission:  https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm284443.pdf

------------------------------
Lauren Kamer RAC
Director of Regulatory
United States

Original Message:
Sent: 24-Apr-2018 05:37
From: Anonymous Member
Subject: 510(k) with Multiple Predicates

This message was posted by a user wishing to remain anonymous

​Hello,

Just from recent experience, we were advised by FDA in a 510k Pre-Sub to only directly use one predicate. We had originally submitted 2 predicates, but had to scale back to one, and use the other as supporting information within the 510k.
Original Message:
Sent: 23-Apr-2018 12:05
From: DEEPA GODHIYA
Subject: 510(k) with Multiple Predicates

Hi, Yes - there can be more than one predicate device in the 510(k). The Substantial equivalence section must include detailed information on the comparison of characteristics of each of the predicate devices to that of the device in question.

More information on the MDR rates using multiple predicate devices can be found here:
Medical Device Reporting (MDR) Rate in 510(k) Cleared Devices Using Multiple Predicates

Best,
Deepa



------------------------------
DEEPA R. GODHIYA
Marlborough MA
United States

Original Message:
Sent: 20-Apr-2018 17:17
From: Anonymous Member
Subject: 510(k) with Multiple Predicates

This message was posted by a user wishing to remain anonymous

​​Hello Regulatory Colleagues,

Is it possible to file a 510(k) with multiple predicates?  If yes, how may this be accomplished?

Thank you.

Hi,

You would need to identify a "Primary Predicate" with indications for use and technological characteristics most similar to your device.  I have submitted a  510k with 1 primary predicate device, 1 other predicate device and 1 reference device successfully.

Good luck with your submission!

Best,
Felicia

------------------------------
Felicia Hosey, RAC
Principal Specialist
Regulatory & Quality Solutions, LLC
http://rqteam.com
------------------------------

Original Message:
Sent: 20-Apr-2018 17:17
From: Anonymous Member
Subject: 510(k) with Multiple Predicates

This message was posted by a user wishing to remain anonymous

​​Hello Regulatory Colleagues,

Is it possible to file a 510(k) with multiple predicates?  If yes, how may this be accomplished?

Thank you.

​Just wanted to piggy-back on what others have said.  I submitted a 510k last fall for a SAMD product (Device A) that was essentially the combination of two other cleared Class II SAMDs (Devices B and C).  I STILL had to pick one of the SAMDs as a "Primary Predicate" device (I chose Device B) and use the other as a "Reference Device" (Device C), even though Device A is a 50/50 combination of the two devices.
Hope this helps!

------------------------------
Rene' Hardee
Sr. Regulatory Affairs Specialist
Marlborough MA
United States
------------------------------

Original Message:
Sent: 26-Apr-2018 08:17
From: Felicia Hosey
Subject: 510(k) with Multiple Predicates

Hi,

You would need to identify a "Primary Predicate" with indications for use and technological characteristics most similar to your device.  I have submitted a  510k with 1 primary predicate device, 1 other predicate device and 1 reference device successfully.

Good luck with your submission!

Best,
Felicia

------------------------------
Felicia Hosey, RAC
Principal Specialist
Regulatory & Quality Solutions, LLC
http://rqteam.com

Original Message:
Sent: 20-Apr-2018 17:17
From: Anonymous Member
Subject: 510(k) with Multiple Predicates

This message was posted by a user wishing to remain anonymous

​​Hello Regulatory Colleagues,

Is it possible to file a 510(k) with multiple predicates?  If yes, how may this be accomplished?

Thank you.