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United States: FDA Third-Party Inspections

U.S. Flag Under the FDA's Inspection Program by Accredited Persons (AP), manufacturers that meet specific criteria can elect to have their choice of accredited third party inspect their facilities in lieu of an FDA official.

This voluntary program enables companies to combine FDA inspections with foreign certification audits, giving them more scheduling flexibility, limiting the administrative impact and streamlining the inspection process.

LNE/G-MED is fully accredited under this program to conduct inspections of eligible class II and III medical device manufacturers, in conjunction with a wide range of other certification services, including ISO quality standards, CE Marking and other foreign requirements to allow for efficient market access to Canada, Europe, Asia and other world markets.

Manufacturer Eligibility

The AP program is intended for manufacturers that operate in a global market and are likely to be subject to multiple inspection requirements. Therefore, manufactures must select an AP with the accreditation of the appropriate foreign country and request FDA clearance to use that specific AP.

In addition, the manufacturer’s most recent inspection must have been classified by FDA as No Action Indicated (NAI) or Voluntary Action Indicated (VAI). Complete FDA Eligibility Rules

Only 15 organizations are approved as an Accredited Person (AP) and LNE/G-MED is among the most active program participants. Our recognition by the FDA for quality system inspection and review of 510(k) submissions began over a decade ago through the U.S./European Mutual Recognition Agreement (MRA).

LNE/G-MED is also among the first organizations able to perform join audits/inspections under the Pilot Multipurpose Audit Program (PMAP) developed by the FDA and Health Canada.

Advantages

Regulators put a high level of confidence in LNE/G-MED services, which is why you can trust us to provide a smooth audit/inspection process that stands up to scrutiny.

As your partner, LNE/G-MED America is committed to helping you understand the regulations and considerations for combining certifications to access world markets and giving you:

Local Washington, DC based office with qualified auditors throughout North America to increase convenience and minimize travel costs
Simultaneous certification for CE Marking, Quality Management Systems (ISO 9001, ISO 13485) and other standards often performed by a single, highly-qualified auditor, to save you time and expense
Widely recognized LNE/G-MED expertise as a European Notified Body (CE 0459), as an Accredited Certification Organization by France's accreditation body COFRAC, as a Registrar accredited by the Standards Council of Canada under the Canadian Medical Devices Conformity Assessment System (CMDCAS) and recognized by Health Canada and as a Third Party Accredited Person by the U.S. FDA
Added services, such as product testing (EMC, electrical, mechanical, CB Scheme), product certification, pre-assessment audits and fast-track or onsite review for CE Marking

LNE/G-MED America offers in-person, online and other customized training on a wide range of certification and quality topics. For details, check out our training schedule or request a customized program.