FDA對于美國代理人的解釋也可以參考看一下的原文：
Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States agent (U.S. agent) for that establishment.
Information about a foreign establishment’s U.S. Agent is submitted electronically using the FDA Unified Registration and Listing System (FURLS system) and is part of the establishment registration process. Each foreign establishment may designate only one U.S. agent. The foreign establishment may also, but is not required to, designate its U.S. agent as its official correspondent. The foreign establishment should provide the name, address, telephone and fax numbers, and e-mail address of the U.S. agent.
The U.S. agent identified will be required to complete an automated process to confirm that they have agreed to act as the U.S. agent. The automated process will forward an email verification request to the U.S. agent. They will be requested to confirm her/his consent to act as a representative/liaison on behalf of the foreign establishment. If the U.S. agent denies consent (or does not respond within 10 business days), the Official Correspondent/Owner Operator of the foreign establishment will be notified and must designate a new U.S. agent to satisfy the regulatory obligation.
Responsibilities of a U.S. agent
The U.S. agent must either reside in the U.S. or maintain a place of business in the U.S. The U.S. agent cannot use a post office box as an address. The U.S. agent cannot use an answering service. They must be available to answer the phone or have an employee available to answer the phone during normal business hours.
The responsibilities of the U.S. agent are limited and include:
assisting FDA in communications with the foreign establishment,
responding to questions concerning the foreign establishment's devices that are imported or offered for import into the United States,

食品FDA認(rèn)證；FDA對食品、農(nóng)產(chǎn)品、海產(chǎn)品的管理機構(gòu)是食品與營養(yǎng)中心（CFSAN），其職責(zé)是確保美國人食品供應(yīng)、干凈、新鮮并且標(biāo)識清楚。醫(yī)療器械FDA認(rèn)證FDA對醫(yī)療器械的管理通過器械與放射健康中心（CDRH）進行的，中心監(jiān)督醫(yī)療器械的生產(chǎn)、包裝、經(jīng)銷商遵守法律下進行經(jīng)營活動。醫(yī)療器械范圍很廣，小到醫(yī)用手套，大至心臟起博器，均在FDA監(jiān)督之下，根據(jù)醫(yī)療用途和對人體可能的傷害，F(xiàn)DA將醫(yī)療器械分為Ⅰ、Ⅱ、Ⅲ類，越高類別監(jiān)督越多。對Ⅰ類產(chǎn)品，企業(yè)向FDA遞交相關(guān)資料后，F(xiàn)DA只進行公告，并無相關(guān)證件發(fā)給企業(yè)；對Ⅱ、Ⅲ類器械，企業(yè)須遞交PMN或PMA，F(xiàn)DA在公告的同時，會給企業(yè)以正式的市場準(zhǔn)入批準(zhǔn)函件（Clearance），即允許企業(yè)以自己的名義在美國醫(yī)療器械市場上直接銷售其產(chǎn)品。至于申請過程中是否到企業(yè)進行現(xiàn)場GMP考核，則由FDA根據(jù)產(chǎn)品風(fēng)險等級、管理要求和市場反饋等綜合因素決定。

什么是FDA?FDA由美國國會即聯(lián)邦授權(quán)，是從事食品與藥品管理的高執(zhí)法機關(guān)。全稱：食品藥品監(jiān)督管理局（Food and Drug Administration）。嚴(yán)格來講并沒有FDA認(rèn)證的叫法，這個FDA自己也說過的。一般大家所說的FDA認(rèn)證主要指以下三種：FDA注冊、FDA檢測與FDA批準(zhǔn)。FDA注冊：對于出口食品、藥品及醫(yī)療器械到美國的企業(yè)，注冊FDA，進行企業(yè)列名與產(chǎn)品列名，否則海關(guān)不予清關(guān)，這是強制性的要求。FDA檢測：FDA檢測更多指的是食品接觸材料的檢測，產(chǎn)品接觸類包裝的檢測，醫(yī)療產(chǎn)品的生物兼容測試，測試等。FDA批準(zhǔn)：這種一般針對藥品比較多，是允許這個藥品上市了。

• 

  青浦申請GLOBALG.A.P認(rèn)證全球GAP認(rèn)證

  25000元

  產(chǎn)品名：GLOBALG.A.P認(rèn)證

• 

  無錫辦理低GL認(rèn)證

  48000元

  產(chǎn)品名：低GL認(rèn)證,低糖食品,低糖認(rèn)證,功能食品

• 

  梅州申請生態(tài)原產(chǎn)地產(chǎn)品保護認(rèn)證咨詢

  50000元

  產(chǎn)品名：生態(tài)原產(chǎn)地產(chǎn)品保護認(rèn)證,生態(tài)原產(chǎn)地,保護產(chǎn)品

• 

  博爾塔拉富硒產(chǎn)品認(rèn)證費用

  15000元

  產(chǎn)品名：富硒產(chǎn)品認(rèn)證,硒的好處

• 

  沈陽申請GAP認(rèn)證

  15000元

  產(chǎn)品名：GAP認(rèn)證,介紹,好處,條件,中心,咨詢,流程,辦理,代辦,費用,機構(gòu),辦理,申請

• 

  房山咨詢歐盟美國日本產(chǎn)品認(rèn)證

  28000元

  產(chǎn)品名：歐盟美國日本產(chǎn)品認(rèn)證,介紹,好處,條件,中心,咨詢,流程,辦理,代辦,費用,機構(gòu),辦理,申請

• 

  江西上饒FDACE認(rèn)證

  8000元

  產(chǎn)品名：FDACE認(rèn)證

• 

  塘沽咨詢生態(tài)原產(chǎn)地產(chǎn)品認(rèn)證

  22000元

  產(chǎn)品名：生態(tài)原產(chǎn)地產(chǎn)品認(rèn)證,無抗食品認(rèn)證,無抗雞蛋認(rèn)證,無抗養(yǎng)殖認(rèn)證,無抗生產(chǎn)認(rèn)證