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 Premarketing Notification 510(k); and most Class III devices require Premarket Approval.
A 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).
Premarket approval (PMA) is required for Class III devices, which are considered high risk and pose a significant risk of illness or injury. PMA’s can also be required if there is not a substantially equivalent Class I or II device to predicate through the 510(k) process. The PMA process is more involved than a 510(k) notification and also requires the submission of clinical data to support claims made for the device.
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
▲Acting as a US agent, which is required for foreign companies who wish to import
their medical devices
into the US. 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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