You may obtain the official new provision for this requirement by referring to the FDA web page at: www.FDA.gov/CDRH. At the page, notice in the lower left hand corner is an icon button: FDAMA {next to Year 2000}. Click on that button, then choose ….Overview- FDA Modernization Act of 1997.

Near the end of the document, Refer to Section 4-17 …..Foreign Manufacturers. We have included this section, below.

Overview -- FDA Modernization Act of 1997

(This page last updated: June 5, 1998)

·        Section 213 - Exemption of Wholesale Distributors from Establishment Registration

·        Section 417 - Registration of Foreign Establishments

Section 417 - Registration of Foreign Establishments            Chapter Contents

Foreign establishments engaged in the manufacture, preparation, propagation, compounding, or processing of a device that is imported, or offered for import, into the U.S. must register their establishments and provide the FDA with the name of the U.S. agent representing their establishment. Foreign establishments must also continue to provide FDA with a list of the devices that they are exporting to the U.S. FDA is also authorized to enter into cooperative agreements with foreign countries to ensure that non-compliant products are refused entry into the U.S. Effective: February 19, 1998

Compliance Consultants proposes that we function as your U.S. representatives. Compliance Consultants is both capable and experienced in new medical product development and representing foreign medical device innovators. We propose to undertake this effort in several phases.

Highlights

1. In addition to representing you to the FDA we also answer your incidiental questions that may arise from time to time.
2. We handle on an expiditied basis any issues regarding the importation of your device.
3. Our obgliation will runs through December 31^st, 2002.
4. Should the FDA regulatory affairs requirements change during this period, we will be obligated to cover the additional effort for no additional cost.
5. Our discount from the standard fee that we quote everyone is contingent upon an early commitment to enable us to register you along with other related registrations.

Detail Functions

As part of our functions, we will

1.         Advise you of all legislative changes which may affect you;

2.            Register as your official U.S. representative which legally binds us for a period through 2002 for these stated regulatory activities,

3.            Register your product and establishment with the FDA (they no longer allow             international manufacturers to register directly). We would be the primary contact;

4.         List your devices with the FDA that are marketed in the United States;

5.         The FDA would contact us directly in your behalf for all

                        a)            product traceability issues,

                        b)            product Complaints,

                        c)            product recalls;

6.         Submit all required MDR reports;

7.         We would represent you with the FDA and U.S. Customs for all

                        a)            product importation issues (customs does detain shipments due to                                                         questions regarding FDA clearances or labeling, and

b)                  any customs seizures of products.

You will discover that having us handle incoming customs shipments and expedite their movements will ultimately be a saving and convenience. When any shipment is in transit, we stay on alert and respond to the U.S. FDA & Customs to ensure no unforeseen delays occurs.

To achieve these functions, we would complete all documents with you and officially file these documents and report their status. Once we notify the FDA and establish our representative position, we are then committed to perform on your behalf. These are not the types of duties that you may require a customer for your products to commit to.

To launch this service, we would charge a fixed fee as quoted for this service based on

our estimate of our labor and expenses to include:

·        a one year, binding agreement that we appearance to the FDA in your place,

·        administrative communications, 

·        all long distance phone calls to you and to Washington,

·        written correspondence, and 

·        filing reports to both you and the FDA.