Regulatory Open Forum

When an IVD is granted market access via the De Novo pathway, does it then become a predicate for other forthcoming devices that have the same technology or intended use? 



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Justin Osmond

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A de novo if granted:
"establishes new "device type" along with classification, regulation, necessary controls and product code"

If the classification after de novo review is II (needing Special controls), then yes, it can be used as predicate for subsequent devices. If de novo is declined and it is classified as Class III, any device using the same technology AND intended use would also require a PMA (because of high risk) hence negating the "substantial equivalence" path.

The 2017 De Novo guidance may provide more background.

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Vidyalakshmi Jayaraman
RA Specialist
Marlborough MA
United States
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Original Message:
Sent: 22-Aug-2018 10:19
From: Justin Osmond
Subject: FDA De Novo and predicate

When an IVD is granted market access via the De Novo pathway, does it then become a predicate for other forthcoming devices that have the same technology or intended use?



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Justin Osmond

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Yes, it does, Justin.

Here's an extract from the October 2017 FDA guidance 'De Novo Classification Process (Evaluation of Automatic Class III Designation): Guidance for Industry and Food and Drug Administration Staff':

"The granting of the De Novo request allows the device to be marketed immediately, creates a classification regulation for devices of this type, and permits the device to serve as a predicate device."

Hope this helps.

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Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Clinical Studies - Regulatory - Quality Systems
Rome, Italy
+39 06 578 2665
rgray@donawa.com
www.donawa.com
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Original Message:
Sent: 22-Aug-2018 10:19
From: Justin Osmond
Subject: FDA De Novo and predicate

When an IVD is granted market access via the De Novo pathway, does it then become a predicate for other forthcoming devices that have the same technology or intended use?



------------------------------
Justin Osmond

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Yep, first to market through a De Novo means that other companies can then use that De Novo approval as their predicate device.  Too bad there is not some exclusivity with that, but you are correct.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 23-Aug-2018 06:25
From: Roger Gray
Subject: FDA De Novo and predicate

Yes, it does, Justin.

Here's an extract from the October 2017 FDA guidance 'De Novo Classification Process (Evaluation of Automatic Class III Designation): Guidance for Industry and Food and Drug Administration Staff':

"The granting of the De Novo request allows the device to be marketed immediately, creates a classification regulation for devices of this type, and permits the device to serve as a predicate device."

Hope this helps.

------------------------------
Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Clinical Studies - Regulatory - Quality Systems
Rome, Italy
+39 06 578 2665
rgray@donawa.com
www.donawa.com

Original Message:
Sent: 22-Aug-2018 10:19
From: Justin Osmond
Subject: FDA De Novo and predicate

When an IVD is granted market access via the De Novo pathway, does it then become a predicate for other forthcoming devices that have the same technology or intended use?



------------------------------
Justin Osmond

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Thank you, All!

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Justin Osmond
Ottawa ON
Canada
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Original Message:
Sent: 23-Aug-2018 10:28
From: Richard Vincins
Subject: FDA De Novo and predicate

Yep, first to market through a De Novo means that other companies can then use that De Novo approval as their predicate device.  Too bad there is not some exclusivity with that, but you are correct.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 23-Aug-2018 06:25
From: Roger Gray
Subject: FDA De Novo and predicate

Yes, it does, Justin.

Here's an extract from the October 2017 FDA guidance 'De Novo Classification Process (Evaluation of Automatic Class III Designation): Guidance for Industry and Food and Drug Administration Staff':

"The granting of the De Novo request allows the device to be marketed immediately, creates a classification regulation for devices of this type, and permits the device to serve as a predicate device."

Hope this helps.

------------------------------
Roger Gray
VP Quality and Regulatory
Donawa Lifescience Consulting
Clinical Studies - Regulatory - Quality Systems
Rome, Italy
+39 06 578 2665
rgray@donawa.com
www.donawa.com

Original Message:
Sent: 22-Aug-2018 10:19
From: Justin Osmond
Subject: FDA De Novo and predicate

When an IVD is granted market access via the De Novo pathway, does it then become a predicate for other forthcoming devices that have the same technology or intended use?



------------------------------
Justin Osmond

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