Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
| 21 December 2011
The US Food and Drug Administration (FDA) released new draft guidance detailing the submission process for products seeking humanitarian use device designation for the US market. The document aims to define expectations for med-tech manufacturers as well as FDA reviewers considering Humanitarian-Use Device (HUD) applications. HUD designation is the first step to market clearance under a humanitarian device exemption. The humanitarian use device program, run by the agency's Office of Orphan Products Development, applies to devices that diagnose or treat diseases and conditions affecting fewer than 4,000 people in the US per year. The draft guidance details how a manufacturer might define a patient population, demonstrate that the device works for that population and how the demonstration varies depending on whether the device is meant for diagnosis or treatment. The watchdog agency is accepting comments on the proposed guidance until 12 March, 2012. (MassDevice)
Tags: humanitarian use device, HUD, Process, submission