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Fish News
Medical Device Approvals and Compliance
Our medical device practice specializes in obtaining marketing authorization from the FDA, without which even the most innovative, life-saving device cannot be legally marketed in the United States. We have assisted clients through the FDA maze for a wide variety of devices, ranging from cutting edge 3-D x-ray equipment to dental cements. Our goal is to ensure clients meet all of their regulatory requirements in the least burdensome manner possible.
We also provide advice regarding off-label marketing and other labeling issues, medical device imports and exports, establishment registration, device listing, recalls, corrective actions, and a myriad of other FDA regulations. We counsel clients regarding the applicability of the FDA's Quality System Regulation to their activities, and help clients prepare for FDA inspections. We assist foreign manufacturers selling devices in the United States make certain that they comply with all relevant regulations.
In addition, we have directly assisted many clients obtain medical device licenses from Health Canada. This provides clients with "one stop shopping" for both the United States and Canada. We also have contacts throughout the world who can provide expert advice on the regulations applicable to their markets. Our familiarity with the international standards process further helps clients streamline the regulatory approval process, both in the United States and abroad.
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