question about clinical trial

Pre-Med & Medical School Careers in Medicine
1

<p>If an independent individual (not affiliated with any hospitals, schools, etc...) or company come up with a device that can be used in the medical field, they technically need FDA approval before it can be marketed for medical use. Most of time, this requires a clinical trial right?</p>

<p>My question is, does the clinical trial have to be performed by certified professionals in the field (MDs, doctors, etc...) or can it be performed by layperson also?</p>

<p>And if it have to be performed by experts in the field, how does one contact/find such people? Do they usually require monetary compensation in order to do a clinical trial for you? </p>

<p>I've already got volunteers. But I just don't know what kind of requirements the FDA requires for the clinical trial. And how to go about it...</p>

<p>Anyone with any knowledge in this area, please help. </p>

<p>Thanks</p>

2

<p>Hi Aihara,</p>

<p>There are strict FDA regulated guidelines for approvals of products. The list of do's and don't is way too lengthy for me to detail out here also my specialty deals with NCEs (new chemical entities for INDs and NDAs). Therefore, I couldn't comment on device approvals.</p>

<p>I would advice you to read these guidelines. Pretty much everything you need can be found by googling the ICH guidelines and FDA guidelines. </p>

<p>Here's a link to FDA's page for devices.</p>

<p><a href="http://www.fda.gov/cber/gdlns/bioplant.htm%5B/url%5D"&gt;http://www.fda.gov/cber/gdlns/bioplant.htm&lt;/a&gt;&lt;/p>

<p>Also peruse the ICH guidelines. CFR 21 applies for everything clinical.</p>

<p>Enjoy perusing and good luck!</p>

3

<p>Ooops!<br>
Here's a better link</p>

<p><a href="http://www.fda.gov/cder/Offices/DSI/regulations.htm%5B/url%5D"&gt;http://www.fda.gov/cder/Offices/DSI/regulations.htm&lt;/a&gt;&lt;/p>