I'm not 100% certain of the following:
As a subcontracted medical device manufacturer (my company does NOT hold the 510k for the product), to meet the requirements of ISO13485, section 8.5.1., should I be notifying the FDA of adverse effects (per 21 CFR 803) or should my customer be doing that (after I notify them of the adverse effects)?
From what I get out of 21 CFR 803, I feel that I have to notify the FDA in addition to notifying my customer. I'm in the ISO 13485 procedure-writing stage and trying to figure out a plan. (I could create an adverse effect just to validate the system
JUST KIDDING!)
Can somebody shed some light on this one?
Thanks!
As a subcontracted medical device manufacturer (my company does NOT hold the 510k for the product), to meet the requirements of ISO13485, section 8.5.1., should I be notifying the FDA of adverse effects (per 21 CFR 803) or should my customer be doing that (after I notify them of the adverse effects)?
From what I get out of 21 CFR 803, I feel that I have to notify the FDA in addition to notifying my customer. I'm in the ISO 13485 procedure-writing stage and trying to figure out a plan. (I could create an adverse effect just to validate the system
JUST KIDDING!)Can somebody shed some light on this one?
Thanks!