I never said they should have an answer in 60 days. I did however point out that it is a possibility. I also believe we will hear within the 90 day timeline. My reasoning is for a couple reasons.
1. The FDA is quite capable of approving traditional submissions in 60 to 90 days. case in point.
Also in latest presentation TN said they are in
Device Classification Name
system, imaging, pulsed echo, ultrasonic
[color=red]510(k) Number
K172142
Device Name
FibroScan 430 Mini+
Applicant
Echosens
30 place d'italie
paris, FR 75013
Applicant Contact
karine bonenfant
Correspondent
Boston MedTech Advisors Inc.
990 washington street
suite #204
dedham, MA 02026
Correspondent Contact
zvi ladin
Regulation Number
892.1560
Classification Product Code
IYO
Subsequent Product Code
ITX
Date Received
07/17/2017
Decision Date
09/13/2017
Decision
substantially equivalent (SESE)
Regulation Medical Specialty
Radiology
510k Review Panel
Radiology
Type
Traditional
Reviewed by Third Party
No
Combination Product
No
active review. This info combined with what I just recently posted
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:
[/color]•Email
•Telephone Call
Tells me that FDA believes it will provide an answer within the 60-90 day window. Maybe you didn't see that post.
For the decision to talk the 9 months or more you referred to would mean they were on hold and not in active review as Dr. Norchi just stated.
