BioPhia Consultant Ed Moore presents a training video as part of the Great Lakes Medical Jumpstart I-CORPS program discussing the regulatory paths associated with medical devices; from ideation, pre-clinical work, full device development, and preparation of a 510K submission leading to successful registration.
The U.S. FDA defines a medical device as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body. Medical devices do not achieve their primary intended purposes through chemical action within or on the body. Three classifications of devices along with general registration requirements for each classification are discussed with examples of specific medical devices given for each classification. This video also describes the Q-Submission program, a non-binding communications channel whereby medical device proposals are submitted to CDRH for review and feedback.
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