FDA 510(k) Submission
510(k) PMNSE LETTER
PREMARKET NOTIFICATION
FDA REGULATORY SUBMISSIONS
The FDA 510(k) is a clearance or premarket notification. The Food, Drug, and Cosmetic Act, Section 510(k) requires device manufacturers to submit a notice to the FDA 90 days before they intend to market a medical device. It is also called 510(k) Clearances, Substantially Equivalent Letter (or SE Letter), or Premarket Notification (PMN). It must not be confused with premarket approval (PMA) under Section 515.
Predicate Device & FDA 510(k)
For new medical devices marketed after 1976, under the Medical Device Amendments to the FD&C Act of 1976, manufacturers must submit a premarket approval under Section 515. However, legally marketed devices before May 28, 1976, are known as a “predicate” or “preamendments device.” These legally marketed devices do not require 510(k) submission or a PMA under Section 515. Therefore, if your device is substantially equivalent (SE) to one of those predicate devices, you can submit a clearance request under Section 510(k).
For some low-risk devices, the FDA may reclassify them to the list of 510(k) exempted devices. The list is updated periodically, so check if your device is also 510(k) exempted.
Even though FDA 510(k) submission is required 90 days before your intent to market your device, it may take longer than 90 days to get a clearance letter from the FDA. Therefore, you may want to plan and submit early. Sometimes it takes less than 90 days, but it could take much longer. Also, there is no form or template for submitting a notification.
In addition, once you receive a substantially equivalent letter, you must also comply with Quality System Regulations (QSR).
AP FDA Consulting offers an all-in-one package services: FDA 510(k) Submission, QSR, and Mock FDA Inspections.
Premarket notification under Section 510(k) is the beginning of your medical device. In addition, you must comply with QSR and be ready for an FDA inspection. Unfortunately, some companies make the mistake of thinking that a 510(k) is all they need to distribute or market a medical device. But it is just the beginning.