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Latest update : 17.01.2014
Marketing medical devices in the United States: LNE G-MED accredited by FDA
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Access to the American market

Certification according to FDA regulations

Regulatory framework

The American market is governed by the Food and Drug Administration (FDA) regulations. There are two types of recognition programme.

Inspection by Accredited Persons (IAP) procedure

Quality system inspection
The principle of third party inspection – the Inspection by Accredited Persons (IAP) Program – was enacted by an amendment to the 2002 Medical Device User Fee and Modernization Act (MDUFMA). It allows manufacturers to have their quality system assessed by a certificated auditor of a third party body accredited by the FDA. In accordance with the Code of Federal Regulations (text 21 CFR 820), this Accredited Person (AP) acts in place of an FDA inspector and sends the FDA a report for determination.
LNE/G-MED is accredited as an AP to perform such inspections.

A manufacturer wishing to place his products on the American market may therefore apply to LNE/G-MED to perform the required inspections.

> Eligibility of manufacturer for inspection by LNE/G-MED

To be eligible for inspection, the company must meet the following criteria:

  • it must design, develop and manufacture class II or III medical devices (American classification)
  • it must already market at least one of its medical devices in the United States
  • its most recent FDA inspection report must be marked NAI (No Action Indicated) or VAI (Voluntary Action Indicated)
  • it must apply for and obtain authorization from the FDA to use LNE/G-MED as its AP body.

> Where to apply for authorization

Food and Drug Administration
Field Programs Branch (HFZ-306)
Office of compliance, CRDH
2094 Gaither Road
Rockville, MD 20850

In its application, the company must:

  • state which AP body has been chosen
  • include documents proving that the company satisfies the eligibility criteria
  • supply details of previous inspections, including the date of the last inspection, the list of observations and a copy of the inspection report.

The FDA has 30 days in which to reply or request additional information. If no reply is received within this period the application is deemed to be accepted. If the FDA rejects the application, the manufacturer may appeal.

For more information about inspection requests under the IAP Program, download the FDA guidelines (58ko) Format PDF

See also the FDA website for more information about the IAP Program

Mutual Recognition Agreement procedure

In the context of a Mutual Recognition Agreement (MRA) signed by the United States and the European Union, LNE/G-MED has been designated as a Conformity Assessment Body (EU CAB) by the French Health Products Safety Agency (ANSM) and the European Commission. It was approved by the FDA in April 2003.
The principle of mutual recognition enables LNE/G-MED to operate according to American regulations and FDA procedures. This does not mean that the FDA recognizes CE marking certification, rather that it recognizes LNE/G-MED's competence.

LNE/G-MED is involved in the Pilot Audit Program (PMAP)developped by FDA (USA) and Health Canada. LNE/G-MED can be requested by medical devices manufacturers to carry out simultaneously:

  • audit according to ISO 13485:2003 and related provisions of the Canadian Medical Devices Regulations
  • inspections according to the U.S. Quality System Regulations 21 CFR Part 820

For more information, please consult Health Canada and FDA websites.

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