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The FDA's role in medical device clinical studies of human subjects.
J Neural Eng. 2005 Mar; 2(1):S1-4.JN

Abstract

This paper provides an overview of the United States Food and Drug Administration's (FDA) role as a regulatory agency in medical device clinical studies involving human subjects. The FDA's regulations and responsibilities are explained and the device application process discussed. The specific medical device regulatory authorities are described as they apply to the development and clinical study of retinal visual prosthetic devices. The FDA medical device regulations regarding clinical studies of human subjects are intended to safeguard the rights and safety of subjects. The data gathered in pre-approval clinical studies provide a basis of valid scientific evidence in order to demonstrate the safety and effectiveness of a medical device. The importance of a working understanding of applicable medical device regulations from the beginning of the device development project is emphasized particularly for novel, complex products such as implantable visual prosthetic devices.

Authors+Show Affiliations

Vitreoretinal and Extraocular Devices Branch, Division of Ophthalmic and ENT Devices, Office of Device Evaluation, CDRH, FDA, USA.

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

15876645

Citation

Saviola, James. "The FDA's Role in Medical Device Clinical Studies of Human Subjects." Journal of Neural Engineering, vol. 2, no. 1, 2005, pp. S1-4.
Saviola J. The FDA's role in medical device clinical studies of human subjects. J Neural Eng. 2005;2(1):S1-4.
Saviola, J. (2005). The FDA's role in medical device clinical studies of human subjects. Journal of Neural Engineering, 2(1), S1-4.
Saviola J. The FDA's Role in Medical Device Clinical Studies of Human Subjects. J Neural Eng. 2005;2(1):S1-4. PubMed PMID: 15876645.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The FDA's role in medical device clinical studies of human subjects. A1 - Saviola,James, Y1 - 2005/02/22/ PY - 2005/5/7/pubmed PY - 2005/7/21/medline PY - 2005/5/7/entrez SP - S1 EP - 4 JF - Journal of neural engineering JO - J Neural Eng VL - 2 IS - 1 N2 - This paper provides an overview of the United States Food and Drug Administration's (FDA) role as a regulatory agency in medical device clinical studies involving human subjects. The FDA's regulations and responsibilities are explained and the device application process discussed. The specific medical device regulatory authorities are described as they apply to the development and clinical study of retinal visual prosthetic devices. The FDA medical device regulations regarding clinical studies of human subjects are intended to safeguard the rights and safety of subjects. The data gathered in pre-approval clinical studies provide a basis of valid scientific evidence in order to demonstrate the safety and effectiveness of a medical device. The importance of a working understanding of applicable medical device regulations from the beginning of the device development project is emphasized particularly for novel, complex products such as implantable visual prosthetic devices. SN - 1741-2560 UR - https://www.unboundmedicine.com/medline/citation/15876645/The_FDA's_role_in_medical_device_clinical_studies_of_human_subjects_ L2 - https://doi.org/10.1088/1741-2560/2/1/001 DB - PRIME DP - Unbound Medicine ER -