Challenges to the FDA Device Approval Process

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Please to read the entire article.

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Posted by Dave Fornell (Discussions: 1, Comments: 1)
Replied on April 10, 2017 12:00 am
Category: Medical Devices
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Please note that is a paper on regulatory approval of medical devices written by someone who, according to their LinkedIn profile, has no degree or certification in regulatory affairs, no experience getting a medical device approved by any regulatory agency, nor any experience in the medical device industry.
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Posted by Julie O. (Discussions: 1, Comments: 7)
Replied on April 10, 2017 8:00 pm
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Plenty of that condition going around?
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Posted by George Butcher (Discussions: 0, Comments: 195)
Replied on April 11, 2017 8:00 pm
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The myths continue to go around:

1. "510k doesn't require clinical evidence" not so for more and more premarket clearances (I just completed a 510k supported by a >6000 patient multicentre international clinical study).

2. "Europe doesn't require efficacy to be proven. " Never so. Europe has always required clinical evidence for ALL devices even Class I. The level of evidence has been according to class with literature and comparison to predicates being the norm for low risk devices and clinical.studies for high risk. The newMDR substantially raises the bar requiring direct clinical studies for all Class III devices.
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Posted by Arthur Brandwood (Discussions: 1, Comments: 1)
Replied on April 11, 2017 8:00 pm
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Actually, ALL 510(k)s require clinical evidence. Only 10-15% of those that are cleared include data from a clinical trial.

What percent include other types of clinical data, I can't say. In what percent of those trials the 510(k) device was used as a test article, I can't say. Whether all these data were "required," I can't say.
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Posted by Julie O. (Discussions: 1, Comments: 7)
Replied on April 11, 2017 8:00 pm
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