FDA Medical devices 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

You might also like:

ME C117 Lecture 09: Total Shoulder Replacements; Contact
ME C117 Lecture 09: Total Shoulder Replacements; Contact...
Reducing Manual Effort for Risk Management Compliance - PTC
Reducing Manual Effort for Risk Management Compliance - PTC
Medical Device Consulting for FDA 510(k) Premarket Notification
Medical Device Consulting for FDA 510(k) Premarket Notification ...

China: life sciences regulatory crackdown spreads to medical device sector  — Lexology
On August 15, 2013, the local Beijing office of the Ministry of Health (MOH) of the People's Republic of China announced (Chinese link) that it has started a three-month review of the use of high-value medical consumables and large-scale medical ..

HYDROMER, INC. : Enters into Supply Agreement with a Chinese Medical ..  — 4-traders
BRANCHBURG, NJ, August 26, 2013 -(ACCESSWIRE)- Hydromer, Inc. (OTC Pink: HYDI) and a Chinese Medical Device company have entered into a Supply and Support Agreement. Under the terms of this agreement, the Chinese ..

FDA Patient Network: Bringing Your Voice to Drug and Device
FDA Patient Network: Bringing Your Voice to Drug and Device ...
Gooding 3 Reasons
Gooding 3 Reasons
Verification & Validation Protocols, Do
Verification & Validation Protocols, Do

Related posts:

  • Avatar Robo Rider How many pharmaceutical companies are in Ireland?
    Jul 14, 2006 by Robo Rider | Posted in Other - Ireland

    Namely pharmagenetics companies that custom make drugs based on a persons DNA code.

    • I hope the following comprehensive list, while perhaps more than you asked for, is helpful to you: Allmarket (Ireland) Ltd - Allmarket (Ireland) Ltd. is a specialised consultancy company offering a full range of services to companies operating in the pharmaceutical sector. The services range from joint ventures and licensing agreements to marketing support, and advice on local market conditions. AstraZeneca Pharmaceuticals - Irish website of AstraZeneca PLC one of the worlds leading pharmaceutical companies with strong research, manufacturing and commercial skills. Bayer Diagnostics …

  • Avatar jaipal What is mean by current good manufacturing practice(cGMP)?
    Jul 23, 2008 by jaipal | Posted in Engineering

    It is mostly used in manufcturing industries mainly chemical and API. It is a standards for quality

    • Good Manufacturing Practice or GMP (also referred to as cGMP or current Good Manufacturing Practice ) is a term that is recognized worldwide for the control and management of manufacturing and quality control testing of foods and pharmaceutical products. Since sampling product will statistically only ensure that the samples themselves (and perhaps the areas adjacent to where the samples were taken) are suitable for use, and end-point testing relies on sampling, GMP takes the holistic approach of regulating the manufacturing and laboratory testing environment itself. An extremely important …