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Frequently Asked Questions

Is there a pre-approval inspection required for 510 (k) clearance?

There is no pre-approval inspection as a prerequisite to 510 (k) clearance. However, you should be prepared for an FDA inspection at any time.

Do I need to submit a 510 (k) form?

Do I need to submit a 510 (k)? No, the manufacture should submit the 510 (k), if required for the device.

What is PMN (premarket notification) or 510 (k)?

Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k).

Can foreign companies submit a premarket notification 510 (k) directly to FDA?

The distributor should forward all product complaints to the manufacturer for evaluation in accordance with 21 CFR 820.198 Complaint files. Can foreign companies submit a Premarket Notification 510 (k)? Yes. The foreign manufacturer may submit a 510 (k) directly to FDA.


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