Medical device importers — new AofC qualifiers for De Novo applications

The Food and Drug Administration (FDA) has begun using a new numbering system for medical device De Novo applications.

Accordingly, the appropriate qualifier for the Affirmation of Compliance (AofC) code PMN will either be K or DEN, followed by 6 digits.

On a related note, previously-granted De Novo applications with 510(k) numbers have been reassigned DEN numbers as well.

Full details are available in US Customs’ CSMS #14-000482.

Also, for a general background, see FDA’s August 2014 draft guidance on the De Novo classification process.