Abstract
You have an idea for a device that will make life easier for patients, physicians, caregivers, or all of the above. That’s great! But now what? Device regulation is a hot topic in industry right now. Because there have been amazing advances in medical device technology, medical device regulation has had to evolve to encompass these complexities. In this changing landscape, it is difficult to know what is required and what next steps you should take. This chapter provides a history of device regulation, but more importantly, it provides information to help you determine what type of device you have; a general development plan; and basic information on the FDA’s classification and regulatory pathways for clearance/approval/grant.
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Halt, G.B., Donch, J.C., Stiles, A.R., VanLuvanee, L.J., Theiss, B.R., Blue, D.L. (2019). General Overview of Development Process. In: FDA and Intellectual Property Strategies for Medical Device Technologies. Springer, Cham. https://doi.org/10.1007/978-3-030-04462-6_2
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DOI: https://doi.org/10.1007/978-3-030-04462-6_2
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