Expanded Patient Access to Investigational New Devices

Summary U.S. Food and Drug Administration (FDA) approval of Class III medical devices can take from 3 to 7 years. Although this is shorter than times for drug approvals, patients with serious or life-threatening diseases and disorders may not have time to wait for device approval to access needed tr...

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Bibliographic Details
Published in:JACC. Basic to translational science 2018-08, Vol.3 (4), p.533-544
Main Author: Van Norman, Gail A., MD
Format: Article
Language:English
Subjects:
3D printing
Cardiovascular
compassionate use
custom medical devices
device regulations
expanded access
FDA device approval
HDE
medical devices
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Description
Summary:Summary U.S. Food and Drug Administration (FDA) approval of Class III medical devices can take from 3 to 7 years. Although this is shorter than times for drug approvals, patients with serious or life-threatening diseases and disorders may not have time to wait for device approval to access needed treatments. The FDA has a number of pathways, similar to drug approval processes, for expanded use of unapproved medical devices in patients for whom no reasonable alternative therapy is available. Additionally, the FDA regulates the manufacture and use of “custom” medical devices—those made for use by 1 specific patient. With the advent of 3-dimensional printing and bioprinting, new rules are evolving to address concerns that lines may be blurred between “custom” treatments and unregulated human experimentation.
ISSN:2452-302X
2452-302X
DOI:10.1016/j.jacbts.2018.06.006