FDA Biennial Registration Renewal of 2020

Your next FDA Biennial Registration Renewal is between October 1 and December 31, 2020.

When you are competing with 300,000+ companies to renew your FDA REGISTRATION, be smart about it.

What to do in the meantime?

Check our Specials

■ Switch U.S. Agent
Limited Offer – $99.00 for Food and Supplements Companies

■ Get a new FDA Registration Number if you failed to renew your company’s registration before December 31, 2018
Limited Offer

■ We offer one low fee for FDA Registration and Product Listing

Food Canning

Drugs

Medical Devices

OTC Cosmetics

Limited Offer | $350.00

■ Need Food or Supplements Label Review?
Limited Offer – $99.00


What are your options?


■ Contact ITB HOLDINGS LLC

Ask for an invoice

Emails without full company name (as registered), street address, city, postal / zip code, country and telephone number will be automatically deleted as junk or spam.

Prepay $99.00

Offer is limited

■ Then, sit back and relax.

Contact ITB HOLDINGS LLC at T : +1 855 510 2240 | T : +1 855 389 7344 | T : +44 800 610 1577 | FDA REGISTRATION for 59 Dollars


What’s included?


■ Food Facility Registration

■ U.S. Agent Service (Foreign Companies)


Any extras? Sure


Prior Notice

■ Foreign Supplier Verification Program – FSVP

■ Registration Certificate

Supplement Facts Label

Nutrition Facts Label


EBAY SHOPPERS: CHECKOUT NOW, HERE


Companies can export or import Foods | Dietary Supplements | Alcoholic Beverages | to or from the United States as long as the facilities that produce, store, or otherwise handle the products are registered with the FDA (Food and Drug Administration), and prior notice of incoming shipments is provided to the FDA.

Food Companies must complete their Biennial Registration Renewal
between October 1 and December 31, 2020
, even if they obtained a
NEW FDA REGISTRATION NUMBER in 2019 or 2020 including on September 30, 2020.


REQUIRED INFORMATION


■ Full company’s name (as registered locally)

■ Street address, city, postal / zip code, state, country

■ Full name of CEO / Manager

■ Telephone number of CEO / Manager

■ Email of CEO / Manager

■ Product details.


Thank you for your business

Join our satisfied clients in 100 countries including China | Japan | South Korea | Germany | France | United Kingdom | Canada | Mexico | Spain | Portugal | Italy | Greece | Netherlands | Belgium | Sweden | Australia | New Zealand | Ireland | Poland | Romania | Russia | Ukraine | India | Pakistan | Taiwan | Brazil | United States.

Our representatives are standing by for any question.


Foreign Languages


Español

Deutsch

Français

Italiano

Nederlands

Português

Русский

中文

Contáctenos | お問い合わせ | 联系我们 | Contact met ons opnemen | Contattaci | связаться с нами | हमसे संपर्क करें | اتصل بنا | Contactez-nous | Kontaktieren Sie uns | Kontakta oss | Kontakt z nami | Kontaktujte nás.


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.

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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 Chat: itbholdings

itbholdings | Skype Call

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