Title |
Expanded Patient Access to Investigational New Devices Review of Emergency and Nonemergency Expanded Use, Custom, and 3D-Printed Devices
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Published in |
JACC: Basic to Translational Science, August 2018
|
DOI | 10.1016/j.jacbts.2018.06.006 |
Pubmed ID | |
Authors |
Gail A. Van Norman |
Abstract |
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. |
X Demographics
Geographical breakdown
Country | Count | As % |
---|---|---|
United States | 2 | 25% |
Chile | 1 | 13% |
United Kingdom | 1 | 13% |
Unknown | 4 | 50% |
Demographic breakdown
Type | Count | As % |
---|---|---|
Members of the public | 3 | 38% |
Practitioners (doctors, other healthcare professionals) | 2 | 25% |
Science communicators (journalists, bloggers, editors) | 2 | 25% |
Scientists | 1 | 13% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 32 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Student > Bachelor | 5 | 16% |
Student > Master | 4 | 13% |
Researcher | 3 | 9% |
Student > Ph. D. Student | 3 | 9% |
Professor | 2 | 6% |
Other | 3 | 9% |
Unknown | 12 | 38% |
Readers by discipline | Count | As % |
---|---|---|
Engineering | 7 | 22% |
Medicine and Dentistry | 4 | 13% |
Agricultural and Biological Sciences | 2 | 6% |
Design | 2 | 6% |
Business, Management and Accounting | 1 | 3% |
Other | 4 | 13% |
Unknown | 12 | 38% |