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HP&M Welcomes Senior FDA Official, Ana Loloei, to the Firm

FDA Law Blog

Loloei also served as a Senior Policy Advisor in CDRH and as a Special Advisor in the Office of the Commissioner. Loloei will focus on guiding clients through complex premarket and postmarket regulatory requirements and assisting with the management of total product life-cycle matters. While at FDA, Ms. During her FDA tenure, Ms.

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The New FDA Draft Human Factors Guidance: A Bridge Too Far

FDA Law Blog

In 2016 , the agency issued its definitive HF guidance, guide manufacturers through human factors engineering processes during the development of new medical devices, focusing specifically on the user interface. Consider this scenario: A manufacturer files a 510(k) for a Class II device, a surgical mask.