§860.230. Accepting a De Novo request. — Inbound Citations

(a) FDA will begin substantive review of a De Novo request after the De Novo request is accepted under § 860.230. Within 120 days after receipt of a De Novo request or receipt of additional information that results in the De Novo request being accepted under § 860.230, FDA will review the De Novo request and send the requester an order granting the De Novo request under § 860.260(a) or an order declining the De Novo request under 860.260(b).

(11) After a De Novo request is accepted for review under § 860.230(b), the requester makes significant unsolicited changes to the device's:

(i) Indications for use; or

(2) The requester fails to provide a complete response to the deficiencies identified by FDA pursuant to § 860.230(c)(2) within 180 days of the date notification was issued by FDA;