FDA Medical Device: Definition,  Approval Process, Regulations, Recalls, Database, Reporting, and Recalls

 A medical device, for use in the Medical Field, must go through an approval process, with stiff regulations, before they are used.  There is a database of reporting and recalls, the regulations of which is found on the FDA website.  Of course, a medical device cannot simply be manufactured, and used. In America, as in most countries of the world, there is an approval process by the government, to show that the device is safe, causes no harm, and has a valid reason to impact medical care.

It can be a long, expensive process, and currently there is a fastrack approval process for medical devices. There are some companies, such as CIMIT, in Boston, that will aid certain projects.

See this video below, of the CIMIT Accelerator Program, for Medical Devices on the sometimes  long, tortuous road to FDA approval

FDA Device Approval Process

All new drugs, and medical gadgets, or devices must get FDA approval before being legally used to treat patients. (see the FDA website for particulars).  The drug approval process is much more rigorous and lengthy, lasting almost a decade.

Basically, there are stages that the proposed medical device  must go through:

1)  For a device, a 510(k) is simply a submission to the FDA of a device to show it is safe and useful, and must be made to the FDA 90 days before going on the market.  To see what devices are in the 510 database, go HERE.  This process is considered to be a “fast-track” loophole for medical devices, since it the proposed devices only needs to show it is similar to an existing product, and some congressmen, as of August 2012, are trying to amend this process that bypasses the normal approval process, since some devices are actually similar to recalled devices.

2) PMA, or pre-marketing submission is stricter, and is a determination of the FDA that the device is safe and medically useful.  To see the database of devices in the PMA stage, go HERE.


FDA Training Videos: Medical Devices
510(k)Process: Discussion

FDA Official Blog

FDA: Latest News on Twitter for Medical Devices



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