Medical Devices on the Market in USA

Premarket Notification 510(k) | Premarket Approval (PMA) | Establishment Registration | www.itbhdg.com

If you’re planning to grow in size, profits, or into new markets, consider expanding to or within the United States.

More than 24,584 domestic (12,848) and foreign (11,736) medical device establishments are registered with FDA.

LIMITED OFFER

* Establishment Registration
* Medical Devices Listing
* U.S. Agent Service (Foreign Companies)
* $350.00 USD | Initial Registration Fee

* $300.00 USD | Annual Fee.

Government Fees are extra.

Premarket Notification 510(k)

Premarket Approval (PMA)


FDA COMPLIANCE

Owners or operators of companies that are involved in the production and distribution of medical devices intended for use in the United States are required to register annually with the U.S. FDA (Food and Drug Administration) and list the devices that are made there. This process is known as establishment registration.

Companies required to register their establishments and list their devices with the FDA

Firms that

* manufacture
* repackage and relabel
* develop specifications
* reprocess single-use devices
* remanufacture
* manufacture accessories and components sold directly to the end user.

WHAT’S INCLUDED?

U. S. Agent service

Medical Device Establishment registration

Medical Device listing

Classification of your medical device to determine the proper FDA product code and regulation number.

Determination of similar (predicate) devices with 510(k) clearance and whether they are suitable for use in your 510(k) submission.

Completion of 21 sections of the 510(k) application.

Payment of 510(k) fees on your behalf (when needed).

Electronic filing of the 510(k) and follow-up with the FDA reviewer.

We speak English, Dutch , French, Spanish, for your convenience.

MORE INFORMATION? Contact us today.

EXTENDED OFFICE HOURS : 3:00 AM – 6:00 PM

Eastern Standard Time – EST

Monday – Sunday

Multilingual and International Team to handle your requests within hours, not days.

FDA Registration of your Medical Device Company and Products | www.m.itbhdg.com | www.itbhdg.com

ITB HOLDINGS LLC
390 North Orange Avenue, Suite 2300
Orlando, FL 32801
United States
T : +1 855 510 2240
T : +1 855 389 7344
T : +44 800 610 1577
Skype: itbholdings

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