S
snoopy2017
Hi everyone,
We recently filed a 510(k) submission. A few days after we submitted the dossier, the engineers made a few design changes without informing Regulatory. There was no documentation of the changes and there was no impact assessment on approval. My question is, while the product is still under review by FDA, can we make amendments to the regulatory submission if these changes were found to be notifiable to the regulatory authority? The 510(K) modification guidance assumes that a product has already been approved, but in our case when the product is pending review, how do we disclose the changes? I understand there are changes that do not require notification, but if the changes are found to significantly affect safety and effectiveness of a product that has just been submitted, what should we do? I look forward to your responses.
Thank you.
We recently filed a 510(k) submission. A few days after we submitted the dossier, the engineers made a few design changes without informing Regulatory. There was no documentation of the changes and there was no impact assessment on approval. My question is, while the product is still under review by FDA, can we make amendments to the regulatory submission if these changes were found to be notifiable to the regulatory authority? The 510(K) modification guidance assumes that a product has already been approved, but in our case when the product is pending review, how do we disclose the changes? I understand there are changes that do not require notification, but if the changes are found to significantly affect safety and effectiveness of a product that has just been submitted, what should we do? I look forward to your responses.
Thank you.
