Key considerations and stages in the development of clinical trials with medical devices: Regulatory Approach
Palabras clave:
Controlled Clinical Trial, Medical devices, Medical Device Legislation, Drug DevelopmentResumen
Traditionally, clinical trials have primarily focused on the research of new drugs, leading to an abundance of pertinent information in the literature, far exceeding that available for medical device trials. This article delves into the essential definitions to fully understand medical device trials. It explores the general characteristics of medical devices, details the technical criteria and stages of studies, and highlights the key differences compared to drug trials. This is done by reflecting the perspective of the National Directorate of Medicines (DNM) of El Salvador, a regulatory agency, regarding these types of trials. The article also includes a description of the legal and regulatory frameworks, both local and international, supporting the regulatory work.
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