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510(k) process

FDA’s 510(k) pre-market review process for medical devices provides strong protections to American patients and promotes medical innovation. It provides FDA the flexibility it needs to ensure the safety and effectiveness of low- and moderate-risk medical devices whose risks are well-understood from experience with similar devices. The 510(k) review process provides for the thorough FDA review of a wide range of products – from syringes to imaging systems – in a timely fashion that facilitates patient access to needed medical advancements. It is common for 510(k) submissions to include hundreds or thousands of pages of documentation, based on:

  • Bench testing;
  • Animal studies (if deemed necessary by FDA);
  • Batteries of non-clinical tests (biocompatibility, shelf-life, shock and vibration, temperature cycling, etc.);
  • Tests demonstrating conformance with national and international standards; and
  • Any additional requirements specified by FDA.

Background of 510(k)

The 510(k) process has a remarkbale thirty year track record of protecting the public health while making safe and effective products available without unnecessary delays.

In January 2011, FDA issued a 510(k) implementation plan outlining the actions it will take to improve the efficiency and predictability of the device review program. FDA’s plan focuses on proposals that will serve to strengthen an already robust program including:

  • Improving consistency through improved guidance document development.
  • Enhancing reviewer training, and
  • Leveraging external scientific experts.