Recall Documentation - Recall Submission vs. Recall Notification

D

DaisyMae

I am writing a Corrections and Removal procedures for medical devices to comply with 21CFR 7, 806 and 810 and when reviewing the guidance documents I see that there are 2 sections listed each describing the required documentation: a Recall Submission and a Recall Notification. Both contain a lot of the same information. What is the purpose of each one and when are they to be submitted to the FDA?
Thanks in advance for your help. This site has been most beneficial and I recommend it all the time. :agree1:
 

Stijloor

Leader
Super Moderator
I am writing a Corrections and Removal procedures for medical devices to comply with 21CFR 7, 806 and 810 and when reviewing the guidance documents I see that there are 2 sections listed each describing the required documentation: a Recall Submission and a Recall Notification. Both contain a lot of the same information. What is the purpose of each one and when are they to be submitted to the FDA?
Thanks in advance for your help. This site has been most beneficial and I recommend it all the time. :agree1:

Can someone help DaisyMae?

Thank you!

Stijloor.
 
B

blewispunk

Hey DaisyMae,

Have you looked at the DeviceAdvice site here: http://www.fda.gov/MedicalDevices/D...ts/RecallsCorrectionsAndRemovals/default.htm? It helps clarify this process which is confusing to many (including myself).

My understanding is that anytime you have a correction/removal event you need to determine if it is reportable or not. If it is a class III recall then it does not need to be reported to FDA but must have some internal documentation. You can notify the FDA of any recall event and they will do their own determination of if it needs to be reported (this is optional). In a recent FDA audit I discussed this with the auditor and also found it a bit confusing that you could submit all the information required in a recall report to FDA to determine if you need to submit a recall report (which by then you have in essence already submitted!), but that truly appears to be the process. So, you can do your own determination or you can send a notice to FDA if you are uncertain and they will help you with the determination.

I have created the attached form to help us work through any correction/removal events and have the documentation necessary.

I'm not sure if this answers your question, but hopefully there is something there that helps.
 

Attachments

  • Incident Evaluation Form.doc
    71.5 KB · Views: 395
Q

qualitymgripi

I am preparing for an AIB audit and I need a mock recall procedure for a corrective action from last years audit
 
Top Bottom