Registrations & Approvals:
Medical Devices

FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel and import medical devices sold in the United States. Medical devices are grouped into three categories known as Class I, II and III, and FDA’s regulatory control increases from Class I to III. Device classification defines the regulatory requirements. Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k); and most Class III devices require Premarket Approval.

Medical Devices in an operating room, with some having been approved through 510(k) notification processA 510(k) notification is a premarket submission to FDA intended to demonstrate that the device to be marketed is at least as effective and safe as a similar legally marketed device. A company cannot commercially distribute a device until it receives a letter of substantial equivalence from FDA giving proper authorization to do so. Today, more than 80% of new medical devices are brought to market using Premarket Notification 510(k).

TSG is actively involved in the medical device industry and our consultants help companies develop a strategy, prepare and submit a 510(k), or provide assistance throughout the entire PMA process, including data requirement issues. We also act as a
U.S. Agent  for companies located outside of the United States.

TSG services include:

▲ Obtaining a medical device producing establishment registration with the FDA. TSG also
offers assistance with device listings to comply with FDA requirements;

▲ Finding a predicate device to base your 510(k) substantial equivalence submission;

▲ Developing medical device labels;

▲ Preparing and submitting required documentation for a complete 510(k) submission.
TSG will also follow up with the FDA during the review process to obtain status updates;
and

▲ Acting as a U.S. agent, which is required for foreign companies who wish to import their
medical devices into the U.S. TSG will also ensure that a company is compliant with U.S.
regulations.

TSG’s consultants work with companies to obtain and maintain compliance with FDA requirements while meeting clients’ marketing goals. With an
office located in Washington D.C., we are in close proximity to the FDA to better represent and protect our clients’ interests.
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