| 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
The data shown below were collected from the profiles of 43 X users who shared this research output. Click here to find out more about how the information was compiled.
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
The data shown below were compiled from readership statistics for 370 Mendeley readers of this research output. Click here to see the associated Mendeley record.
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% |
Attention Score in Context
This research output has an Altmetric Attention Score of 178. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 18 May 2023.
All research outputs
#225,448
of 25,373,627 outputs
Outputs from JACC: Basic to Translational Science
#17
of 799 outputs
Outputs of similar age
#4,481
of 367,717 outputs
Outputs of similar age from JACC: Basic to Translational Science
#1
of 15 outputs
Altmetric has tracked 25,373,627 research outputs across all sources so far. Compared to these this one has done particularly well and is in the 99th percentile: it's in the top 5% of all research outputs ever tracked by Altmetric.
So far Altmetric has tracked 799 research outputs from this source. They typically receive a lot more attention than average, with a mean Attention Score of 20.4. This one has done particularly well, scoring higher than 97% of its peers.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 367,717 tracked outputs that were published within six weeks on either side of this one in any source. This one has done particularly well, scoring higher than 98% of its contemporaries.
We're also able to compare this research output to 15 others from the same source and published within six weeks on either side of this one. This one has done particularly well, scoring higher than 93% of its contemporaries.