Welcome Black Doggie,
Valid question. Not sure if the company is required to announce a delay. I too suspect not, although some here would argue it is a material event that would trigger an 8k. Some companies do announce delays. CAPR just announced that FDA said their drug application may work but the company needs to do more work to prove it. In the case of Arch Dr. Norchi just stated on the 11th that AC5 is under active review.
Substantive Review (including Substantive Interaction and Interactive Review)
During Substantive Review, the Lead Reviewer conducts a comprehensive review of the 510(k) submission and communicates with the submitter through a Substantive Interaction, which should occur within 60 calendar days of receipt of the 510(k) submission.
The Substantive Interaction communication is typically:
•an email stating that FDA will proceed to resolve any outstanding deficiencies via Interactive Review; or
•an Additional Information (AI) request which places the submission on hold.
Interactive Review
If the Lead Reviewer chooses to continue with an Interactive Review, this means the Lead Reviewer has determined that any outstanding deficiencies may be adequately addressed within the timeframe set by the Medical Device User Fee Amendment of 2012 (MDUFA III) performance goal for a 510(k) (90 FDA days) and that the submission will not be placed on hold. The Lead Reviewer communicates with the submitter during the Interactive Review using tools such as:
•Email
•Telephone Call
During Interactive Review, the Lead Reviewer may request additional information from the submitter, who may either send the information to the Lead Reviewer directly or to the DCC. Note: During Interactive Review, any information submitted to the DCC must include a valid eCopy
My guess is since Dr.Norchi made sure to say it was in active review that the submission will fall into the 90 day time frame.
This is not a yes or no answer but hope it helps.
