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) 
See also the FDA website for more information about the IAP Program
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.
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 (AFSSAPS) 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 .
> Scope of the MRA
The MRA covers:
- premarket notification 510(k) assessment. This involves demonstrating that the device under consideration is equivalent to a device already on the American market, in terms of its therapeutic or diagnostic indications, its intended use and its technical characteristics (design, materials, etc.). LNE/G-MED will assess the manufacturer's file and forward its conclusions to the FDA for determination.
- quality system inspection, performed according to FDA rules . Inspections are delegated by the FDA to a certificated LNE/G-MED auditor (ie. an auditor who has completed the required training). The inspection procedure is identical to the procedure in the IAP Program.
> Medical devices covered by the MRA
For the 510(k) assessment, the list of devices covered by the MRA is limited to certain European class IIa products included in the restrictive list drawn up by the FDA (American class II or I).
These devices include:
- anaesthesiology: nebulizers
- cardiology: non-invasive blood pressure measurement systems, ECGs, cardiac monitors
- dentistry: resin cements, alloys, dental instruments
- gastroenterology and urology: endoscopes and examination equipment, lithotripters
- general hospital equipment: incubators, infusion pumps, sterilizers
- neurology: EEGs, stimulators
- obstetrics and gynaecology: ultrasonic imagers
- ophthalmology: examination equipment
- physical medicine : wheelchairs
- radiology: diagnostic equipment.
The MRA imposes no restrictions concerning quality system inspection. All manufacturers of medical devices may apply for a third party audit by a Conformity Assessment Body (EU CAB).
> Eligible companies
European companies are eligible under this bilateral US/EU agreement. As soon as the MRA comes into full operation, they will be able to apply to LNE/G-MED for 510(k) assessment. LNE/G-MED will be delegated by the FDA to perform quality system inspections.
For more information on how the MRA works, see these sites: