Regulatory Open Forum

For class III devices the sponsor is establishing the safety and effectiveness of the device but for a De Novo the sponsor is utilizing general and special controls to establish a reasonable assurance of safety and effectiveness. So could a device that has been granted a De Novo market in ad/prom as safe?

If a device is really a low or medium risk (class I or II device), presented to FDA in a deNovo, and judged to be safe and effective and that "in general similar" devices which are subject to identified special controls are also safe and effective, then I would say safe enough.

Safety is never an absolute, to mis-quote Paracelsis, everything is a drug and everything a poison - it is the dose that makes the difference. Nothing is ever risk free but we have to balance advancing medical care with oversight and caution, so for me the deNovo system offers "reasonable safety and innovation".

But if you ask me if anything is "safe", by implication that means absolutely safe, my answer has to be no, there is always the potential to cause harm with the most innocuous object! So to answer your question, I would never market something as "safe" in marketing because that implies an absolute.

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Neil Armstrong FRAPS
MeddiQuest
Peterborough UK
Waterford Ireland

Original Message:
Sent: 26-Apr-2024 16:42
From: Anonymous Member
Subject: Can a De Novo granted device be marketed as safe?

This message was posted by a user wishing to remain anonymous

For class III devices the sponsor is establishing the safety and effectiveness of the device but for a De Novo the sponsor is utilizing general and special controls to establish a reasonable assurance of safety and effectiveness. So could a device that has been granted a De Novo market in ad/prom as safe?

Hello Anon,

This sounds like some phrase or words being used in promotion or claims as a device being "safe" which should use some caution.  As Neil said, nothing is ever safe - but risk management, risk controls, conveying information, design, etc., can try to make the device as safe and effective (performs) as possible, but never completely safe.  Considering a De Novo pathway, the FDA designates the device as able to marketed - sort of in between approved like a PMA and cleared like a 510(k) - more on the side of "being cleared".  Reviewing back to the FD&C Act there is wording and context about a device being safe and effectiveness, but the owness is still on the manufacturer to ensure all regulations are being followed, Good Manufacturing Practices (GMP), compliance, etc., for selling any medical device in the United States.  And most other countries around the world have similar approach and thought process.  So, use caution in labelling or promotion about calling a device "safe" because not only from a regulatory perspective, but could open the company up to standard lawsuits if someone does get hurt ... and the company saying the product is safe.

If a device is really a low or medium risk (class I or II device), presented to FDA in a deNovo, and judged to be safe and effective and that "in general similar" devices which are subject to identified special controls are also safe and effective, then I would say safe enough.

Safety is never an absolute, to mis-quote Paracelsis, everything is a drug and everything a poison - it is the dose that makes the difference. Nothing is ever risk free but we have to balance advancing medical care with oversight and caution, so for me the deNovo system offers "reasonable safety and innovation".

But if you ask me if anything is "safe", by implication that means absolutely safe, my answer has to be no, there is always the potential to cause harm with the most innocuous object! So to answer your question, I would never market something as "safe" in marketing because that implies an absolute.

------------------------------
Neil Armstrong FRAPS
MeddiQuest
Peterborough UK
Waterford Ireland

Original Message:
Sent: 26-Apr-2024 16:42
From: Anonymous Member
Subject: Can a De Novo granted device be marketed as safe?

This message was posted by a user wishing to remain anonymous

For class III devices the sponsor is establishing the safety and effectiveness of the device but for a De Novo the sponsor is utilizing general and special controls to establish a reasonable assurance of safety and effectiveness. So could a device that has been granted a De Novo market in ad/prom as safe?