Substantial equivalence

Substantial equivalence refers to the comparison of a new device to one or more previously approved devices (predicates) in order to establish similarity in intended use, design, energy used or delivered, materials, performance, safety, effectiveness, labeling, biocompatibility, standards, and other applicable characteristics. This comparison is necessary to support claims of substantial equivalence and is often used as a means of obtaining approval for new devices through a 510(k) clearance process.From: The Medical Device R&D Handbook [2019], Toward standardized premarket evaluation of computer aided diagnosis/detection products: insights from FDA-approved products [2020], MRI-guided endovascular intervention: current methods and future potential [2022], Pervasive Computing in Healthcare [2019], An exploratory analysis of U.S. FDA Class I medical device recalls: 2014–2018 [2018]

United States Medical Device Regulatory Framework

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Published in Jack Wong, Raymond K. Y. Tong, Handbook of Medical Device Regulatory Affairs in Asia, 2018

James Bertram

Demonstration of SE does not imply the new and predicate devices must be identical. Substantial equivalence is established with respect to intended use, design, energy used or delivered, materials, chemical composition, performance, safety, effectiveness, labeling, biocompatibility, standards, and other technological characteristics, as applicable.

Regulatory convergence of medical devices: a case study using ISO and IEC standards

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Journal Information

Published in Expert Review of Medical Devices, 2018

Kuniki Imagawa, Yoshiaki Mizukami, Seiko Miyazaki

In the USA, medical devices are regulated under the Federal Food, Drug, and Cosmetic Act, which gives authority to the Food and Drug Administration (FDA) to regulate food, drugs, medical devices, biologics, cosmetics, and radiation-emitting products in the USA. Medical devices are overseen by the Center for Devices and Radiological Health (CDRH), a branch of the FDA. The FDA publishes regular notices in the Federal Register about recognized consensus standards and their recognition and use [16]. In the FDA Guidance titled ‘Guidance for Industry and FDA Staff. Recognition and Use of Consensus Standards’ [17], the FDA describes that when the recognized standard includes specific acceptance criteria that describe relevant performance characteristics of that specific medical device, conformity to the recognized standard should minimize the amount of data and documentation needed in the 510(k) submission to demonstrate substantial equivalence. Basic information on regulations applicable to the EU and outside the EU, including the USA, were previously reported in detail [18,19].

Substantial equivalence

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United States Medical Device Regulatory Framework

Regulatory convergence of medical devices: a case study using ISO and IEC standards