Medical Devices

Bustos Law Group offers a full suite of legal and FDA consulting compliance services relating to medical device compliance. Medical devices are defined by the Food, Drug and Cosmetic Act as, “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory . . . intended for use in the diagnosis of disease or other conditions . . . or intended to affect the structure or any function of the body.” Medical Devices are regulated by class. These classes range from Class I to Class III which is the most highly regulated. Medical device compliance is vital before heading to market.

Services Include: Classification, 510k/ Premarket Clearance, Premarket Approval, De Novo, Label Reviews, Marketing Reviews, GUDID, UDI, Quality System Regulation compliance, facility audits, registration & listing