Customer Complaint - Samples vs. Removal - FDA Requirements

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RobertMMolinaro

FDA defines Removal as "the physical removal of a device from its point of use to some other location for repair, modification, adjustment, relabeling, destruction, or inspection."

If a medical device company receives a customer complaint and asks for samples back to support the investigation, would FDA consider that to be a Removal, i.e. a Recall?

Technically the device has been removed from its point of use for inspection in this scenario; however the failure may or may not be confirmed, and the company has not yet made a decision to remove additional product from the marketplace.

Put another way, does the removal start when the company decides to formally pull back product from the market or when the first potentially defective sample is returned?
 

shimonv

Trusted Information Resource
Hi Robert,
The best way to answer your questions is a quotation from the regulation - 21 CFR 806.10(a):

"(a) Each device manufacturer or importer shall submit a written report to FDA of any correction or removal of a device initiated by such manufacturer or importer if the correction or removal was initiated:

(1) To reduce a risk to health posed by the device; or

(2) To remedy a violation of the act caused by the device which may present a risk to health unless the information has already been provided as set forth in paragraph (f) of this section or the corrective or removal action is exempt from the reporting requirements under 806.1(b)."

Correction or Removal comes after investigation, when there is a risk to health.

BR,
Shimon
 
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