FDA Medical devices Regulatory

About Us | REGULATORY DOCTORREGULATORY DOCTOR | Global Regulatory

Benefit from our extensive experience in the creation of Premarket Notifications (510 (k) s).

Medical device manufacturers who want to take class II medical devices to the U.S. market, the market usually require a "FDA clearance" for this product. It is the submission of documents under Section 510 (k) of the Federal Food, Drug, and Cosmetic Act, the FDA allowed to decide whether the medical device with an already marketed medicinal product is essentially similar. Can not be furnished proof of equivalence, the medical device manufacturers a PMA for this product may need to obtain.

Not just the marketing of a new product requires a 510 (k), but possibly also the change of a product that already had a 510 (k) clearence. Further developments of its own product range should therefore be carried out in close coordination and collaboration with Regulatory Affairs personnel.

PROSYSTEM offers you a comprehensive package for the preparation and submission of your 510 (k) to:

  • Analysis of the medical device to determine the classification and identification of regulatory Number
  • Compile a list of the documents required for a 510 (k)
  • Identifying one or more products for comparison 510 (k)
  • Analysis of all relevant FDA guidelines
  • Preparation of the required chapters of the 510 (k), in cooperation with your staff
  • Submission of the 510 (k) with the FDA
  • Coordination of answering any FDA requests
  • Assistance in paying for the 510 (k) fees to the FDA

If you have brought to the U.S. market no products on the market, we are happy to assist you with the registration and listing.

Contact us for more details or a quote.

2006-02-20 17:02:02 by Bioseeker

8 years in biotech

I've been working consistently in the biotech field, after a BA in Psychobiology for 8 years.
-Regulatory Affairs deals with getting FDA approval of new drugs and medical devices.
I went to the Biospace job fair last month but haven't got any calls. I'm wondering if its b/c I currently reside in LA. I'm thinking of moving down there and looking for something fast thru a temp agency. Any advice?

2009-01-11 15:13:59 by windshadow

More from hsi

Last month, a group of FDA scientists sent an SOS to Representative John D. Dingell, chairman of the House Committee on Energy and Commerce. The letter calls for "urgent intervention" due to "serious misconduct" by managers of the Center for Devices and Radiological Health (CDRH) – the FDA division that oversees everything from imaging equipment to breast implants.
So what constitutes "serious misconduct"?
Here's how the scientists put it: "There is extensive documentary evidence that managers at CDRH have corrupted and interfered with the scientific review of medical devices

2007-09-08 13:08:25 by -------

Chip implants shown to cause cancer, a

-
"When the U.S. Food and Drug Administration approved implanting microchips in humans, the manufacturer said it would save lives, letting doctors scan the tiny transponders to access patients' medical records almost instantly. The FDA found "reasonable assurance" the device was safe, and a sub-agency even called it one of 2005's top "innovative technologies."
But neither the company nor the regulators publicly mentioned this: A series of veterinary and toxicology studies, dating to the mid-1990s, stated that chip implants had "induced" malignant tumors in some lab mice and rats

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