Update: Check first with FDA regarding their current availability to review a human factors validation test protocol
Updated on August 12, 2021
In recent years, the US Food and Drug Administration has strongly encouraged medical device manufacturers to submit human factors (HF) validation test protocols for agency review prior to testing. Paraphrasing, FDA’s message to industry is to let the agency check the manufacturer’s protocol before the test commences to assess whether (1) the test method aligns with the agency’s expectations, and (2) data is being collected and analyzed in a sufficiently rigorous manner.
In recent years, the US Food and Drug Administration has strongly encouraged medical device manufacturers to submit human factors (HF) validation test protocols for agency review prior to testing. Paraphrasing, FDA’s message to industry is to let the agency check the manufacturer’s protocol before the test commences to assess whether (1) the test method aligns with the agency’s expectations, and (2) data is being collected and analyzed in a sufficiently rigorous manner.
