Unnecessary Modification Clinical Evaluation 510(k)

T

Tonyw

#1
Hi all,

I am new to the regulatory field and was reading an FDA guidance document when I came upon an interesting section (to me) in regards to modification to medical device that if it relates to safety, clinical evaluation can be unnecessary. For those who have experience in the field, do you mind sharing with me reasons why clinical evaluation can be unnecessary when modifying a device in regards to safety? Just trying to understand the concept better.

The guidance statement is below.

?If you make a modification that affects usability as it relates to safety, then you should either perform a clinical evaluation or justify in writing to FDA why you believe that a clinical evaluation is unnecessary.

Thank you in advance!

Tony
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hi all,

I am new to the regulatory field and was reading an FDA guidance document when I came upon an interesting section (to me) in regards to modification to medical device that if it relates to safety, clinical evaluation can be unnecessary. For those who have experience in the field, do you mind sharing with me reasons why clinical evaluation can be unnecessary when modifying a device in regards to safety? Just trying to understand the concept better.

The guidance statement is below.

“If you make a modification that affects usability as it relates to safety, then you should either perform a clinical evaluation or justify in writing to FDA why you believe that a clinical evaluation is unnecessary.

Thank you in advance!

Tony
Hello and welcome to the Cove :bigwave:

It would have helped if you specified what guidance docuemnt you're referring to. FDA has hundreds of them.

I'm guessing that it's one that relates to usability. If it is, then it means that this guidance applies from the usability aspect. it doesn't necessarily cover ALL aspects of device modifications. Sometimes applicable guidance is scaterred across multiple resources.

Last, the quote you included only says that if you think that clinical evaluation is not necessary in a certian case such as the one described, you should tell the FDA about it, trying to convince them that you are right (justify).

Cheers,
Ronen.
 
Last edited:
T

Tonyw

#3
Hello and welcome to the Cove :bigwave:

It would have helped if you specified what guidance docuemnt you're referring to. FDA has hundreds of them.

I'm guessing that it's one that relates to usability. If it is, then it means that this guidance applies from the usability aspect. it doesn't necessarily covers ALL aspects of device modifications. Sometimes applicable guidance is scaterred across multiple resources.

Last, the quote you included only says that if you think that clinical evaluation is not necessary in a certian case such as the one described, you should tell the FDA about it, trying to convince them that you are right (justify).

Cheers,
Ronen.
Thanks for the welcome Ronen!
 
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