Title |
Drugs, Devices, and the FDA: Part 2 An Overview of Approval Processes: FDA Approval of Medical Devices
|
---|---|
Published in |
JACC: Basic to Translational Science, June 2016
|
DOI | 10.1016/j.jacbts.2016.03.009 |
Pubmed ID | |
Authors |
Gail A. Van Norman |
Abstract |
As with new drugs, the U.S. Food and Drug Administration's approval process is intended to provide consumers with assurance that, once it reaches the market place, a medical device is safe and effective in its intended use. Bringing a device to market takes an average of 3 to 7 years, compared with an average of 12 years for drugs. However, there are concerns that Food and Drug Administration processes may not be sufficient to meet the assurances of safety and efficacy as intended. This second part of a 2-part series reviews the basic steps in development and Food and Drug Administration approval of medical devices, and summarizes post-marketing processes for drugs and devices. |
X Demographics
Geographical breakdown
Country | Count | As % |
---|---|---|
United States | 16 | 37% |
Ecuador | 3 | 7% |
United Kingdom | 1 | 2% |
Colombia | 1 | 2% |
Spain | 1 | 2% |
Unknown | 21 | 49% |
Demographic breakdown
Type | Count | As % |
---|---|---|
Members of the public | 37 | 86% |
Practitioners (doctors, other healthcare professionals) | 3 | 7% |
Scientists | 2 | 5% |
Science communicators (journalists, bloggers, editors) | 1 | 2% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
United Kingdom | 1 | <1% |
Finland | 1 | <1% |
Unknown | 368 | 99% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Student > Bachelor | 59 | 16% |
Student > Master | 58 | 16% |
Researcher | 41 | 11% |
Student > Ph. D. Student | 39 | 11% |
Other | 18 | 5% |
Other | 42 | 11% |
Unknown | 113 | 31% |
Readers by discipline | Count | As % |
---|---|---|
Engineering | 78 | 21% |
Medicine and Dentistry | 32 | 9% |
Biochemistry, Genetics and Molecular Biology | 29 | 8% |
Pharmacology, Toxicology and Pharmaceutical Science | 20 | 5% |
Agricultural and Biological Sciences | 15 | 4% |
Other | 72 | 19% |
Unknown | 124 | 34% |