A HUD is a “medical device intended to benefit patients in the...

A HUD is a “medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year” (21 CFR 814.102(a)(5))

The only restrictions are on profit making with an HUD - exempted in those under 22 years of age.

Further to my post on HUD granted for the FDA - the table below outlines the next steps for and HDE submission and time frame once the HDE has been submitted and compares the difference between the traditional route and HUD route

HDE approval authorizes marketing of an HUD device for its specified indication for use. The regulation (21 CFR 814, Subpart H) describes the application, review, and post-approval regulatory requirements for HDEs.HDE approval is based upon, among other criteria, a determination by the FDA that the HUD will not expose patients to an unreasonable or significant risk of illness or injury and the probable benefit to health from use of the device outweighs the risk of injury or illness from its use (while taking into account the probable risks and benefits of currently available devices or alternative forms of treatment).The law exempts HDE devices from demonstrating a reasonable assurance of effectiveness, and instead requires demonstration of probable benefit. This difference in determination of effectiveness is a key difference between applications for premarket approval (PMA) and HDE devices.

Source - FDA

https://www.fda.gov/medical-devices/humanitarian-device-exemption/getting-humanitarian-use-device-market


So from the table

* HUD Designation for oncosil - intrahepatic (ICC) and distal cholangiocarcinoma (dCCA)
* Will not expose patients to significant risk - demonstrated in the other pancreatic cancer trials - may be also demonstrated in a small feasibility study or clinical study ?
* Demonstrate probable benefit - likely require small clinical study and supported by therapy in pancreatic cancer - The FDA guidance states non-clinical testing can “obviate or reduce the need for clinical testing,” leaving scope for the FDA to request data from humans without articulating the type of study it would demand. Clinical investigations include study protocols, safety and probable benefit data, adverse reactions and complications, device failures and replacements, patient information, patient complaints, results of statistical analyses and any other relevant information from the clinical investigations.
* 75 days
* Facilities that have only IRB oversight (ethics boards) makes sense as the only places where oncosil will target will be large hospitals with interventional radiotherapy or gastroenterology support
* Restrictions on profit - This is the one problematic area that will need to be examined by Oncosil. Profit can be made in patients less than 22 years old. What the definition of profit is is possibly not clearly defined. If it adjusts for in house expenses may include staff costs etc and reduce the burn rate. Also to take advantage of logistics where clinical trials are being undertaken for pancreatic and liver indications large USA centres. It also good for marketing and getting the product known for rare indications. It also establishes a platform for logistics and service provision. Also engages the right clinical staff for training in using the device, such that when profitable indications are approved there is operator experience.