CLINICAL STUDY OVERSIGHT - USTR can assist to tailor a clinical study that handles the correct data so it is an effective tool for the FDA, medicare, ama and insurance companies. If the clinical study does not correctly document this type of information, the product will have a difficult to impossible time to get insurance to pay for the product or to pay for it at an amount required to make a profit. The study requires development as a code marketing tool
510k - One of the two types of FDA authorization that permits a medical device or procedure be legally marketed and sold in the us. The medical device must be substantially equivalent to an already authorized FDA device or procedure.
PMA - A pma filing is required when the medical device or procedure is not substantially equivalent to something already being marketed, has a higher level of risk in use and is based on a new technology where clinical studies are required before authorization is obtained to market and sell the medical device or procedure.
US AGENT - The us agent responsibilities include assisting the FDA in communications with the foreign establishment. Any and all communications through the agent are equivalent to communications directly to the foreign establishment.
OFFICIAL CORRESPONDENT- Its responsibilities include the annual registration of the medical device manufacturer and the submission of the device listing forms.
MANUFACTURING FACILITY REVIEW - The FDA requires that the medical device manufacturing facility meets the FDA quality systems regulation. An outside audit of the manufacturing facility by an experienced independent auditor can help your company meet the requirement.
SADMERC APPROVAL - SADMERC is a national entity that provides services under contract to Medicare. SADMERC offers guidance to manufacturers and suppliers on the proper use of medicare codes by which durable medical equipment are identified for Medicare billing. Medicare requires a formal SADMERC verification review for certain products before the product can be billed to Medicare.
