The borderline product we will be discussing is intended to treat blood outside the body through a mixture of two chemical gases to reduce pathogens.

The Primary Mode of Action (PMOA) is through one of the chemical gases in the mixture. The regulatory status of this chemical gas as a medicinal product is unclear. Due to this, it is challenging to categorize this product as a medicinal product on the basis of its PMOA. On the other hand, it is difficult to categorize the product as a medical device, since this device causes chemical/biological changes to the blood that is re-introduced into the body.

Speakers:  

Farha Sayeed is an Associate Consultant within Regulatory Affairs at SDS MedteQ, a consultancy firm based in Stockholm.  She collaborates primarily with early-stage startups for the development and submission of medical devices and drug-device combination products. She is involved in establishing the regulatory roadmap, product classification and formulating the regulatory strategy for a wide variety of Class II and Class III medical devices as well as drugs and biologics used in combination with delivery devices.

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