Basic information about FDA’s Premarket Notification (510(k))

What is 510(k)?

510(k) is FDA`s premarket notification. FDA “clears” 510(k) submissions, authorizing a device to market in the US. That’s why it is called “Premarket notification”

Premarket Notification (510(k)) is based on substantial equivalence of the device to be marketed with a predicate device already available in the US. During the review of the 510(k) file, if the FDA finds the device as Substantially Equivalent (SE) the FDA will give the clearance with a "k" number.

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Is 510(k) applicable for all the devices?

The Medical device that are regulated by FDA needs 510(k).

Premarket notification (510(k)) is required for

o Some class I devices

o Most of the class II devices

o Some class III devices

Majority of the devices (Low Risk devices) need not go through 510(k) process. Nearly all Class II devices must procure a 510(k). FDA approves majority of Class III devices via PMA (Premarket Approval).

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Types of 510(k) Submissions-

o Traditional 510(k)

o Abbreviated 510(k)

o Special 510(k)

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How to Submit?

A 510(k) submission is done through an eCopy. It is the electronic version of submission created and submitted through a CD, DVD or flash drive. Size of total submission should not exceed 1 GB.

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Format of an eCopy submission

• Non-volume based structure recommended for small submissions

• Volume based structure recommended for large or complex submissions

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FDA 510(k) Review Cycle

A typical FDA 510(k) review period after submission is usually 90 days. However, in reality, on an average it takes five to 6 Months -

o Day1: 510(k) submission is received by FDA along with the proof of payment

o By Day 7: FDA sends and acknowledgement letter

o By Day 15: FDA informs about the acceptance of submission for substantive review or the review is placed on RTA hold.

o By Day 60: FDA conducts substantive review and asks if additional information is required.

o By Day 90: FDA issues 510(k) clearance, provided no additional information being requested.

Reality: Most of the companies get Additional Information requests, so average clearance time is five to six months.

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