The United States remains the largest consumer and producer of medical devices in the world. For international companies that are looking to expand into the US market, dealing with regulatory delays and complexities can be overwhelming. Summit has the experience and expertise to assist in navigating regulatory obstacles and developing domestic supply chains. Summit’s outsourcing solutions add credibility to your organization, expand distribution flexibility and deliver products rapidly and cost effectively gaining you a real advantage in the marketplace.
FDA – The Food and Drug Administration (FDA) is the agency responsible in the United States for protecting the public's health by overseeing medical products, including devices. http://www.fda.gov/MedicalDevices/
CDRH - The FDA regulates the safety and efficiency of medical devices through the Center of Devices and Radiological Health (CDRH).