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.
We walk you through the best approach to 510(k) submissions in our article, 5 Ways to Ensure your 510k Submission Testing Goes off Without a Hitch.
Our 510(k) testing services
Appropriately selected 510(k) testing of the predicate and submitted device must be designed and performed with the outcome documented and reported to demonstrate equivalence.
Element offers an extensive range of testing services to help you obtain market clearance, from chemical and mechanical testing to pharmaceutical testing for combination devices. Working closely with your regulatory team, we help you select appropriate tests for your 510(k) submission. In addition to commonly used standards, our Engaged Experts can formulate non-standard test protocols for evaluating specific functional aspects of devices for which there are no standardized tests.
We are FDA registered and ISO/IEC 17025 accredited to ensure the technical integrity of the 510(k) testing we carry out, ensuring your devices are accepted as an integral part of your submission.
For more information about our medical device testing services or to request a quote, contact us today.
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)
For more information on 510(k) clearances, please visit www.fda.gov.
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