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FDA Medical Device Listings

  • FDA 510(K) APPLICATIONS/ SUBMISSIONS
    FDA 510(K) APPLICATIONS/ SUBMISSIONS
    FDA APPLICATIONS/ SUBMISSIONS In 1938 congress passed a set of laws giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics. Section 510(k) requires Medical Device manufacturers to register and notify FDA, at least 90 days in advance, of their intent to market a medical device in the USA. This is called the Premarket Notification (PMA).... FDA APPLICATIONS/ SUBMISSIONS In 1938 congress passed a set of laws giving auth...
  • FDA Medical Device Listings
    FDA Medical Device Listings
    Device listing service per product Device listing service per product ...