T
Tonyw
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
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