Successful FDA 510(k) submissions are critical to your market success. Incomplete or inaccurate submissions can lead to failure and may delay your product launch.
510(k) or Premarket Notification (PMN) sections of the Food, Drug and Cosmetic Act require manufacturers to notify the FDA of their intent to market a new medical device 90 days before market release. Specifically, medical device manufacturers must submit their 510(k) or PMN if they intend to introduce a device into commercial distribution for the first time or if they are reintroducing a device with significant changes that could affect its safety. Such changes can include modifications to design, material, chemical composition, energy source, manufacturing process or intended use.
Appropriately selected tests of the predicate and submitted device must be designed and performed with the outcome documented and reported to demonstrate equivalence.
Exova offers an extensive range of testing services to help you obtain market clearance. We test according to ASTM, ISO, USP and other applicable standards. Working closely with your regulatory team, we help you select appropriate tests for your 510(k) submission. We can also formulate non-standard test protocols for testing specific functional aspects of devices for which there are no standardized tests.
Exova provides experience in many different areas of medical devices, from chemical and physical testing to pharmaceutical testing for combination devices. We are FDA registered and ISO/IEC 17025 accredited through A2LA and the Standards Council of Canada to ensure the technical integrity of the tests we carry out, ensuring they will be accepted as an integral part of your submission.
For more information on 510(k) clearances, please visit www.fda.gov.
FDA 510(k) General Information
- Required Submission of Safety and Effectiveness Information for Certain Class III Devices
- The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications - Final Guidance
- Refuse to Accept Policy for 510(k)s - Guidance for Industry and Food and Drug Administration Staff (PDF - 1.1MB)
- FDA-Cleared Sterilants and High-Level Disinfectants with General Claims for Processing Reusable Medical and Dental Devices - March 2009 [ARCHIVED]
- Premarket Notification 510(k)
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