FDA 21 CFR 803 Device Malfunction

There is a definition of "malfunction" that FDA provided in their 2016 guidance on MDR reportability. The definition goes:

"Malfunction means the failure of a device to meet its performance specifications or otherwise perform as intended [21 CFR 803.3]. Performance specifications include all claims made in the labeling for the device."

Would breach in sterile barrier packaging fall under this definition since packaging may not have performed as intended (did not maintain sterile barrier) and device not longer sterile (does not meet its sterility claim)?

 

What's the purpose of the question? It's certainly a nonconformity and falls under the categories of complaints.

 

The purpose of the question is to understand whether complaints where there is suspected sterile barrier breach (ex: hole in packaging) is reportable to FDA. There is no doubt that this is a nonconformance but not all nonconformances are required to be reported to FDA; so the question is - is it reportable per 21 CFR 803?

 

Ah, that clarifies, thanks.

I'm not a regulatory expert so don't take this as gospel, but the regulation (803.10) seems to suggest that it would NOT be reportable, unless it caused an adverse event.

Definitely confirm with your regulatory expert.