FDA-Related Services

TÜV SÜD Canada Inc. is authorized by the FDA under the Accredited Persons program to submit 510(k) applications on behalf of medical device manufacturers for all eligible Class I & II devices as well as provide Third-Party FDA Inspections.

Why is a 510(k) Required?
In order to market a medical device in the United States, a formalized report must be submitted to FDA for review and acceptance.  TÜV SÜD Canada specializes in assisting medical device manufacturers with this process.  

FDA is organized into various specialized program Centers that are responsible for protecting the public''s health. At TÜV SÜD Canada, we have extensive experience dealing with the FDA's Center for Devices and Radiological Health, which is the group responsible for protecting and ensuring the safety and effectiveness of medical devices.

TÜV SÜD Canada will assist you in determining the regulations and requirements that will be applied by the FDA. We then evaluate your product to the applicable requirements and work with you to ensure that your product and your manufacturing processes are in full compliance. We have built our reputation through our ability to move our clients products through the FDA review process quickly and without difficulty.

What is a 510(k)?
The term 510(k) originates from section 510(k) of the Federal Food, Drug, and Cosmetic Act. Also known as a premarket notification, a 510(k) submission allows the U.S. Food and Drug Administration (FDA) to determine whether a device is substantially equivalent to a device already legally marketed in the United States. Medical device manufacturers are required to submit a 510(k) if they intend to introduce a device into commercial distribution in the U.S. for the first time or if they reintroduce a device that is changed or modified to the extent that its safety or effectiveness could be affected. Such a change may relate to the design, material, chemical composition, energy source, manufacturing process or intended use.

Obtaining FDA Approval
To obtain approval to market your medical product in the USA, a formalized dossier must be completed and submitted to FDA. The type of documentation required for submittal varies depending on the classification of your medical device. Some medical devices may only be subject to general regulations that apply to all devices. Others, such as life-sustaining equipment, require documented clinical and laboratory test data to demonstrate the safety and effectiveness of the device.

Medical devices are classified into three main categories by FDA: Class I, Class II and Class III, based on the level of control necessary to assure the safety and effectiveness of the device.

Class I and Class II Medical Devices require a pre-market notification also known as a 510(k). The 510(k) application is submitted to FDA to demonstrate that the medical device is substantially equivalent to an existing, legally marketed device. New product types, and products classified as Class III require a different process called Pre-Market Approval (PMA).

TÜV SÜD Canada's Role
TÜV SÜD Canada has been involved in the FDA 510(k) third-party review program since its inception in 1996. Today, TÜV SÜD Canada offers third-party submission services for over 600 devices. For a list of devices TÜV SÜD Canada is eligible to review, visit the FDA website.

Benefits of using TÜV SÜD Canada

• In addition to providing 510(k) reviews for U.S. market access, TÜV SÜD Canada can provide market access to Europe, Canada, and Japan offering manufacturers a single-source solution to their regulatory needs.
  
  
• TÜV SÜD Canada is approved to review all eligible Class I and Class II devices. Our authorization to review all eligible devices is reflective of the strength of our staff and our dedication to the industry. Currently, TÜV SÜD accounts for over half of the third-party 510(k) submissions.
  
  
• Prompt service is the hallmark of our reputation. For our 510(k) services this means that if the 510(k) submission requires additional information, TÜV America will continue the review process (if possible) while waiting to receive any missing information.
  
  
• As part of our commitment to facilitating open communication, our staff will stay in contact with manufacturers throughout the review process. This greatly accelerates the review process because we are able to address and correct any issues or omissions as they arise.

Manufacturers can also obtain FDA guidance on compiling their 510(k) through FDA Publications (FDA 95-4158 and FDA 89-4203), FDA's website www.fda.gov and DSMA’s Facts-On-Demand service at 800 899 0381.

For more information, contact us, or download our application form here, and return to Dawn Tibodeau at dtibodeau@tuvam.com.

To further assist our clients, TÜV SÜD Canada has supplied the following answers to the following frequently asked questions. Feel free to contact us if further clarification is required.

View a PDF copy of Frequently Asked Questions.

Helpful Links

FDA Device Advice: Premarket Notifications (510k)
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm

FDA Device Advice: Classification of Devices
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/default.htm

FDA Device Advice: How to Find a Predicate Device:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134571.htm

Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm084365.htm

FDA CDRH Learn
 http://www.fda.gov/Training/CDRHLearn/default.htm