TÜV Rheinland^®

Approach

Under the Third Party Review program, TÜV Rheinland is authorized to conduct the primary review of a 510(k) for an eligible device. We conduct the primary review and then forward our review, recommendation, and the 510(k) to the U.S. Food and Drug Administration (FDA). By law, the FDA must issue a final determination within 30 days after receiving the recommendation of an Accredited Person (AP).

The basic process is as follows:

• Submit a request for quote
• Submit your 510(k) submission to TÜV Rheinland
• TÜV Rheinland conducts the review
• TÜV Rheinland submits your 510(k) submission to the FDA for final review
• The FDA reviews file and communicates its decision in writing to TÜV Rheinland

The following documents are need for the review:

• A coversheet clearly identifying the type of 510(k) – “Special,” “Abbreviated,” or “Traditional”
• 510(k) documentation required under 21 CFR 807 Subpart E, including but not limited to:
• Description of the device
• Intended use of the device
• Proposed labeling for the device
• 510(k) summary or statement
• Data and or information to address issues not covered by guidance documents, special controls, and/or recognized standards
• Truthful and accurate statement
• Summary report that describes how the guidance and/or special control(s) were used to address risk (for submissions that rely on a guidance document(s) and/or special control(s)), with sufficient detail provided to justify that approach

For submissions that rely on a recognized standard, a declaration of conformity (DoC) to the recognized standard shall include:

• Identification of the applicable recognized consensus standards
• Specification and justification of the differences that can exist between the tested device and the device to be marketed
• Name and address of any test laboratory or certification body involved and list of accreditations of those organizations
• Specification, for each consensus standard, that all requirements were met except when:
  
  • Identification of any way(s) in which the consensus standard may have been adapted
  • Identification of any requirements is not applicable
• Specification of any deviations from each applicable standard that were applied

More Information

The term 510(k) is a reference to the Federal Food, Drug and Cosmetics Act section 510(k), otherwise known as “Pre-Market Notification.” The information required in a 510(k) submission can be found in the code of Federal Regulations, Title 21, Part 807, and Subpart E. The 510(k) process checks that a new product is substantially equivalent (SE) to a legally marketed device that is not subject to premarket approval (PMA). Applicants must compare their 510(k) device to one or more similar devices currently on the U.S. market and make and support their substantial equivalency claims.

The U.S. Food and Drug Administration (FDA) 510(k) Third Party Review Program allows outside FDA-accredited organizations to conduct 510(k) reviews. The purpose of the program is to maintain high-quality 510(k) reviews and shorten review times by using outside expertise and resources. The overall efficiency of the Third Party Review Program enables quicker time to market.

A successful 510(k) submission results in FDA permission to market the new device. The nature of this comparison depends on the device and the degree of risk associated with its use. The comparison may comprise physical or performance characteristics as measured by standardized methods.

A legally marketed device is a device that was legally marketed prior to May 28, 1976 (pre-amendments device); a device that has been reclassified from Class III to Class II or I; a device that has been found to be substantially equivalent to such a device through the 510(k) process; or a device established through Evaluation of Automatic Class III Definition. The legally marketed device(s) to which the equivalence is drawn is known as the “predicate” device(s).

Related Services from TÜV Rheinland

If you’re interested in TÜV Rheinland’s FDA 510(k) third party services, you may also be interested in these services:

• CE certification of medical devices
• International approvals
• EMC
• CB scheme
• EN ISO 13485 (and EN ISO 9001)
• Certification of QM systems for processing medical devices in risk categories up to and including C-critical
• GM mark
• TÜVdotCOM
• AIMD
• MDD
• IVDD directives
• Canada CMDCAS

Examples

Pre-Market Notification submissions for medical gloves are usually based on physical characteristic testing conducted using standard methods developed by ASTM International (formerly called The American Society for Testing and Materials) and on biocompatibility testing performed in accordance with the standard ISO 10993 (ISO stands for International Organization for Standardization). These tests measure the ability of a glove to resist leakage and stretching and the degree to which the materials used are compatible with human tissues.

Products Covered

Our services cover Class I, II, and III medical devices, including active implantable medical devices and in-vitro diagnostic medical devices.