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510 (k) Premarket Notification

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PRE-MARKET NOTIFICATION - 510(k)

Today over 80% of new medical devices are brought to market using Premarket Notification or 510(k). TSG has experience in the preparation of 510(k)’s and can alsoact as an US Agent.

TSG can provide services for the medical device industry and assist companies with developing a strategy, and the preparation and submission of the 510(k).

  • Medical Device Establishment Registration. TSG has experience with obtaining a medical device producing establishment registration with the FDA. We also offer assistance with device listings to comply with FDA requirements
  • Strategy Development. TSG can assist you with finding a predicate device to base your 510(k) substantial equivalence submission with. TSG can also assist on medical device label development
  • Preparation of the 510(k). TSG can prepare and submit all required documentation for a complete 510(k) submission. TSG will also follow up with the FDA during the review process to obtain status updates
  • US Agent. Having a US Agent is a requirement for foreign companies who wish to import their medical devices into the US. TSG can act as your agent and ensure that you are compliant with US regulations

TSG is qualified to assist medical device companies in achieving their marketing goals. Located in Washington D.C, we are in close proximity to the FDA so we can better protect our clients’ interests.

TSG is prepared to assist your company in obtaining and maintaining compliance to the FDA requirements so you can sell your product. If you have any questions related to your product, or want to discuss how TSG can assist you, please contact Heather Bjornson at (202) 828-8945.