Adverse Events and Product Recalls - Example forms and procedures wanted

B

bobbyv

#1
Hi Everyone,:)

I am currently working on implementing CFR 820 regulations for a medical device company.
We are ISO 9001 and 13485 compliant but I am trying to make sure we cover all regulatory requirements.

Do we need to have comprehensive forms and procedures for Adverse Events and product recalls?
Wasn't clear from these sections:

Section 15. Complaints
Includes MDR reporting but not much on recall requirements.

Section 12. Product Evaluation
Mentions Non conforming product and failure Investigation.

Not sure if the other CFR codes detailing recall procedures are relevant here?
Recalls, Corrections and Removals (Devices)

21 cfr 7 for example

cheers,

Bobbyv
 
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howste

Thaumaturge
Super Moderator
#2
Re: Need forms and procedures for Adverse Events and product recalls?

Hi Bobbyv, welcome to The Cove forums. :bigwave:

I've moved your post to its own thread in the 21 CFR part 20 forum. Hopefully it will get more attention here.
 
B

bobbyv

#3
Re: Need forms and procedures for Adverse Events and product recalls?

Thanks Howste, much appreciated,:)
 
C

ctregoning

#5
Re: Need forms and procedures for Adverse Events and product recalls?

Hi Bobby,

You sure do need procedures for product recall & adverse event reporting.

We manufacture medical devices and are 13485 registered. We have an occasional adverse event, at least under the definition of one according to the FDA. You can read about adverse event reporting on their website. I use their forms and keep an electronic copy and a hard copy, plus the form letter they send saying they received my report. The most important thing is to DOCUMENT, DOCUMENT, AND THEN DOCUMENT. Of course it the product mishap has to become a CAPA or Complaint with in depth investigation of the root cause and the ensuing corrective action. One mistake I made once that an investigator caught was I didn't record what we told the "complainant." I just recorded that we explained the findings to the complainant, but the FDA wanted (wants) to see it in black & white exactly what was said and done.
All in all, it is not that involved. Just document! But do put procedures in place.
Good luck!
Cherie Tregoning
 
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