FDA Third-Party Inspections

Under the FDA's Inspection by Accredited Persons program, TÜV SÜD America Inc. is accredited as an "Accredited Person" to conduct inspections of eligible class II and III medical device manufacturers.
As an Accredited Person, TÜV SÜD America is authorized to conduct establishment inspections in lieu of an FDA official for "establishments that manufacture, prepare, propagate, compound, or process class II or class III devices, that are required in section 510(h), or inspections of such establishments required to register pursuant to section 510(i) of the Federal Food, Drug and Cosmetic Act (the act)."

What is the Inspection by Accredited Persons Program?
Due to decreasing resources and significant growth of the medical device industry, the ability of the FDA to meet the U.S. Food, Drug and Cosmetic Acts requirement to inspect manufacturers of Class II and III medical devices at least once every two years has become more and more challenging. The need to adjust their inspection policy resulted in the development of the Inspection by Accredited Persons Program.

Under the Medical Device User Fee and Modernization Act of 2002, Section 201 - subsection "g" of section 704 (Factory Inspection), the FDA implemented the third-party inspection program designed to alleviate the FDAs inspection challenge while continuing to ensure appropriate manufacturing conditions and controls are in place to produce safe and effective products.

Implementation of the program not only allows the FDA to utilize its inspectional resources in a more flexible manner, it also provides manufacturers an alternative to the traditional FDA inspection. By utilizing an Accredited Person, manufacturers can decrease disruptions by combining multiple country audits, saving time, resources, and money.

Manufacturers' participation in the program is voluntary. However, not all medical device manufacturers are eligible to utilize the program. The manufacturer must meet several criteria and obtain clearance from the FDA to use an AP. Eligibility criteria consist of:

• The manufacturer’s most recent inspection was classified by the FDA as No Action Indicated (NAI) or Voluntary Action Indicated (VAI).
• The manufacturer must submit a request for approval to use an AP to the FDA, including the identity of the AP.
• The manufacturer must market a device in the US and markets (or intends to market) a device in a foreign country.
• The AP identified in the request must be certified, accredited, or otherwise recognized by one of the foreign countries in which the device is to be marketed.
• The manufacturer must submit a statement that the laws of one of the countries in which the device is to be marketed recognize an inspection of the establishment by the FDA.
  

As part of the requirements of the program, all Accredited Persons must undergo a thorough training from the FDA prior to conducting any FDA inspections. TÜV SÜD inspectors have completed FDA training and are currently in the final phase of being authorized by the FDA through joint inspections.

TÜV SÜD America is accepting inquiries from medical device manufacturers that will agree to host one of the required joint inspections by TÜV SÜD and the FDA. There are two types of inspections, which every prospective auditor has to conduct:

1. Modified Performance Inspection: This inspection is performed by a TÜV SÜD auditor. The FDA investigator will observe and evaluate the trainee performance and may provide assistance.
2. Full Performance Inspection: The TÜV SÜD auditor will perform an independent Inspection and will be observed and evaluated by the FDA investigator using established criteria. The FDA investigator will not provide assistance to the trainee.

Contact us, if your company is interested in hosting a joint inspection.

Benefits of using TÜV SÜD America

• In addition to providing FDA inspections for US market access, TÜV SÜD can provide market access to Europe, Canada and Japan, offering manufacturers a single-source solution to their regulatory needs.
• TÜV SÜD America is one of only 15 organizations worldwide accredited to the new third-party inspection program allowing accredited organizations to conduct independent inspections of eligible medical device manufacturers' facilities.
• TÜV SÜD is no stranger to the FDA and the medical industry; our long involvement includes the FDA 510(k) third-party review program since its inception in 1996. Today, TÜV offers third-party submission services for over 600 devices.
  

In addition, through the US/European Mutual Recognition Agreement (MRA), TÜV SÜD America’s parent company has been providing third-party inspections accepted by the FDA since 1998. Because of TÜV SÜD’s MRA involvement, the FDA views TÜV SÜD’s MRA-qualified auditors as possessing the necessary training and they are therefore currently allowed to provide AP Inspection services.

For more information, contact us.