Medical Devices

Navigating the complexities of getting your medical device to market can be an overwhelming task. Knowing where to begin can sometimes be the most difficult step.

The three steps in beginning the process consist of establishing that the device meets the FDA definition of a medical device; second, determining the device classification and third, determining what data is required for regulatory clearance to market your device. Class I, II and some Class III devices intended for human use in the U.S. must submit a 510(k) to FDA at least 90 days before marketing unless the device is exempt from 510(k) requirements. Applicants may compare their 510(k) device to one or more similar devices currently on the U.S. market and make supported substantial equivalency (SE) claims. The legally marketed device(s) to which equivalence is drawn is known as the "predicate" device(s). Applicants must submit descriptive data and, when necessary, performance data to establish that their device is SE to a predicate device. Again, the data in a 510(k) is to show comparability, that is, substantial equivalency (SE) of a new device to a predicate device.

Once the data requirements have been established there are generally several phases in the safety evaluation; Material Characterization and Screening, Material biocompatibility, Product and Process Validation and lot - to - lot release testing.

The Toxicology Group, LLC has expert staff prepared to assist you in dealing with these complex issues and assist you in getting your medical device to market. Compliance assistance includes advising of testing requirements and facilitating the completion of testing. Our experience in toxicology, chemistry, and microbiology ensures the appropriate tests are conducted. If testing is performed by another laboratory, The Toxicology Group, LLC can review all of the data to assure it meets the requirements of the FDA and European Union (EU) regulations. The Toxicology Group's experience with FDA testing requirements will reduce time spent on trial and error, consequently decreasing the amount of time for a product to reach its market.

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