What is the processing time for an Abbreviated 510(k) submission?

The processing time for an Abbreviated 510(k) submission is generally 90 days. This timeline is established by the FDA to allow sufficient time to review the submission’s content, ensuring that the device is safe and effective while also meeting applicable regulatory requirements. The 90-day period includes the time needed for the FDA to perform their review of the submitted data, which often involves evaluating conformity with existing standards, assessing data from comparative clinical studies or other necessary documentation, and determining whether the device is substantially equivalent to a legally marketed predicate device.

This regulatory pathway is designed to expedite the approval process for certain types of medical devices that can demonstrate substantial equivalence, thereby facilitating patient access to innovative therapies while still ensuring product safety and efficacy. Knowing the processing timeline is critical as it helps manufacturers plan their market entry strategies effectively.