de novo pathway

FDA details switch to electronic filings for 510(k), de novo submissions
Medtech Dive
Wed, 10/4/23 - 09:46 am
FDA
Medtech
de novo pathway
devices
FDA classifies slew of class II devices following de novo procedures
RAPS.org
Wed, 01/4/23 - 05:24 pm
FDA
devices
Medtech
SaMD
de novo pathway
FDA expands eSTAR filing to de novo devices, IVDs
RAPS.org
Thu, 12/2/21 - 10:56 pm
devices
FDA
regulatory
de novo pathway
eSTAR
FDA Publishes De Novo Classification Final Rule with Few Changes from the Proposed Rule
FDA Law Blog
Mon, 10/25/21 - 11:58 pm
FDA
regulatory
de novo pathway
devices
FDA resists industry push to nix De Novo inspections in final rule
Medtech Dive
Tue, 10/5/21 - 10:47 am
FDA
regulatory
de novo pathway
devices
Medtech
Unified agenda: FDA publishes lengthy to-do list
RAPS.org
Wed, 07/8/20 - 11:49 pm
FDA
regulatory
devices
de novo pathway
Non-surgical Device for BPH Wins De Novo from FDA
Medical Devices and Diagnostics Industry
Mon, 04/6/20 - 09:41 pm
devices
FDA
de novo pathway
Or Akiva
iTind
Olympus
BPH
benign prostatic hyperplasia
De novo device clearances fall out of fashion
EP Vantage
Wed, 07/17/19 - 12:06 pm
de novo pathway
FDA
devices
FDA’s De Novo Program Gains Momentum
RAPS.org
Thu, 04/4/19 - 11:04 pm
FDA
de novo pathway
devices
device approvals
Saranas’ Early Bird catches nod from FDA
Mass Device
Wed, 03/6/19 - 08:12 pm
devices
Saranas
FDA
Early Bird endovascular bleed monitoring
de novo pathway
FDA Wants to Change the De Novo Pathway
Medical Devices and Diagnostics Industry
Tue, 12/4/18 - 11:29 pm
FDA
devices
de novo pathway