Worldwide Medical Device Regulatory Updates

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That\'s why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you. No fluff, just straight to the point. We hope you\'ll enjoy the content.

FDA Guidance on HUD Designations Out for Comment

The US Food and Drug Administration has opened a 90-day comment period for draft guidance on Humanitarian Use Device (HUD) designations.

The HUD designation program, run by the Office of Orphan Products Development (OOPD), enables qualifying medical devices to be considered for marketing approval via a Humanitarian Device Exemption (HDE) application. HDE applications are similar to premarket approval applications, but do not require manufacturers to demonstrate reasonable assurances of effectiveness.

The draft guidance covers the following HUD-related issues:

Demonstrating that the device seeking HUD designation targets diseases affecting less than 4,000 people annually in the US
Variations of that demonstration depending on whether the device is designed for therapeutic or diagnostic use
How device properties affect that demonstration
Definition of a plausible patient population for the disease in question

Interested parties have 90 days to submit comments on the FDA’s proposals.