About FDA applications
The medical device industry in the United States is monitored by the American Food and Drug Administration (FDA). In order to sell a medical device in the United States, a company and its product must be registered (listed) with the FDA. Just like in the EU, this places requirements on both the product and the organization’s quality management system. All medical devices are classified and, depending on the product classification, are usually registered as either a 510 (k) or a PMA (Pre Market Approval). Non-US companies also need to have a US agent in the US in order to register their operations in the US. The requirements for quality management systems are outlined in 21CFR820 (QSR).
What Symbioteq can do
Symbioteq helps companies to register their products in the United States. We can, for example help you with a preliminary regulatory analysis to evaluate which classification and the requirements you need in order to gain market access, and then support you throughout the process of obtaining the 510 (k) or PMA. Symbioteq can also help you to establish or add a quality management system in order to become “QSR compliant” or undertake a “mock audit” to ensure that you are ready for an upcoming FDA inspection.
Via our partners in the United States, we can also provide an acting US agent.
Symbioteq is your partner for all matters relating to MDD, AIMD, IVDD, ISO 13485, ISO 9001, ISO 14971, IEC 60601, EN 62366, IEC 62304, ISO 10993, QSR (FDA 21 CFR Part 820), and other regulations and standards in medical device industry.