| Services as United States Agent for Medical Devices |
According to the regulation Section 417 of the Food and Drug Administration Modernization Act of
1997 (FDAMA) requires that any establishment engaged in the manufacture, preparation,
propagation, compounding, or processing of a drug or device imported into the United States must
register with FDA and identify: the name and address of the establishment; and the name of the
United States agent for the establishment. On November 27, 2001, FDA published the final regulation
implementing these requirements (Federal Register, Vol 66). The effective date of the regulation was
February 11, 2002.
For Medical Devices, all foreign establishments must notify FDA of the name, address and phone
number of their United States agent. The regulation (21 CFR 807.40) states that each foreign
establishment may designate only one United States agent who is either a resident of the United
States or maintains a place of business in the United States. The foreign establishment may, but is
not required to, designate its United States agent as its Official Correspondent.
Dalton Instrument provides the service as a FDA United States Agent for Medical Devices. This service
helps our customers of the foreign establishment to register with FDA and identify the name and
address of the establishment and the United States agent for the establishment.
Our responsibilities as the United States agent include:
1997 (FDAMA) requires that any establishment engaged in the manufacture, preparation,
propagation, compounding, or processing of a drug or device imported into the United States must
register with FDA and identify: the name and address of the establishment; and the name of the
United States agent for the establishment. On November 27, 2001, FDA published the final regulation
implementing these requirements (Federal Register, Vol 66). The effective date of the regulation was
February 11, 2002.
For Medical Devices, all foreign establishments must notify FDA of the name, address and phone
number of their United States agent. The regulation (21 CFR 807.40) states that each foreign
establishment may designate only one United States agent who is either a resident of the United
States or maintains a place of business in the United States. The foreign establishment may, but is
not required to, designate its United States agent as its Official Correspondent.
Dalton Instrument provides the service as a FDA United States Agent for Medical Devices. This service
helps our customers of the foreign establishment to register with FDA and identify the name and
address of the establishment and the United States agent for the establishment.
Our responsibilities as the United States agent include:
 | assisting FDA in communications with the foreign establishment, | |
| responding to questions concerning the foreign establishment's products that are imported or | |
| offered for import into the United States, and | ||
| assisting FDA in scheduling inspections of the foreign establishment. | |
| if FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide | |
| information or documents to us, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment. |
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| Dalton Instrument |
Phone: 469-522-1200
24 hr Fax: 469-522-1202
24 hr Fax: 469-522-1202
FDA US Agent
