FDA 510k Third Party Review and Certification

Get FDA 510(k) Certification for Your Medical Technology

The U.S. Food and Drug Administration (FDA) instituted the 510(k) program for companies to demonstrate the safety and effectiveness of their devices. As an 'Accredited Person', TÜV Rheinland is authorized to perform third party 501(k) reviews and inspections for Class I, II, and III medical devices. We offer FDA 510 (k) inspections to assist companies comply with the pre-market notification requirements of the FDA. Working with TÜV Rheinland shortens the time it takes to get your medical device to market. Our team will work with you to identify and collect all the documents required by the FDA 510k regulation. We act as your intermediary with the FDA, submitting and receiving reports and results on your behalf.

Benefits at a Glance

With FDA 510(k) Third Party services from TÜV Rheinland, you can:

  • Ensure quicker time to market with faster clearance
  • Save cost and time by eliminating multiple inspections
  • Benefit from our years of experience and expertise
  • Use a single source for all your testing and compliance needs
  • Reduce the risk of liability with proper documentation
  • Gain a lead against competition in the global marketplace

Our Services for FDA 510(k) Reviews

As an Accredited Person (AP) TÜV Rheinland is authorized by the U.S. Food and Drug Administration (FDA) to perform Third-Party reviews and inspections for eligible devices. Under this program, medical device manufacturers can request Third-Party reviews of 510(k) submissions for eligible devices and TÜV Rheinland can perform these inspections against the U.S. Quality System Regulations. 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

About the FDA 510(k) Review Program

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.

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:

Products Covered

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

Example for Pre-Market Notification Submission

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 bio-compatibility 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.