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Case Studies
Over-The-Counter (OTC) Light Therapy Device
A manufacturer of laser and light-based therapy instruments was seeking advice and assistance in securing 510(k) clearance for a home-based acne treatment device. By leveraging its extensive space knowhow (offering the largest and most comprehensive database of pertinent regulations for light-therapy services in all 50 states), Boston MedTech Advisors was able to devise an integrated regulatory and clinical evidence strategy for the client company.
Following negotiations with FDA of the appropriate clinical study protocol, and closely collaborating with the client, Boston MedTech CRO developed the complete set of documents required to secure IRB approvals of a protocol that supported the formation of clinical data required to comply with new and strict FDA requirements for an OTC marketed device. Boston MedTech CRO provided the monitoring of the clinical study activity in the US, and data analysis of both the US and international sites.
Following a successful study, Boston MedTech Advisors submitted the required 510(k) filing, and pursued an extensive series of negotiations with the FDA, resulting in successfully obtaining the first OTC designation for this type of product, providing the company with considerable differentiation and strong market position.