Start Up, Substantial Equivalence (SE), De Novo, and EU-MDR/IVDR Devices have high quality, affordable products that improve the quality of life for their patients. However, this often is associated with austere conditions wherein time and funds are both in short supply. Read https://biotechresearchgroup.com/fda-de-novo-medical-devices/

1. FDA De Novo & Medical Devices
Start Up, Substantial Equivalence (SE), De Novo, and
EU-MDR/IVDR Devices have high quality, affordable
products that improve the quality of life for their patients.
However, this often is associated with austere conditions
wherein time and funds are both in short supply.
Effective and consistent compilation of Design Control-
Device and Process Development for inclusion in the
electronic submission of an 510(k), De Novo, HDE, and
PMA can reduce costs and timelines.
Effective cost and timeline reductions as most likely
achieved via proactive, early utilization of 510k

2. Consultants, Medical Device Consulting, EU-
MDR/IVDR Consulting, and effective Q-Sub Meetings
collectively resulting in FDA and Regulatory Body
Clearance/Approval.
The purpose of the electronic submission, as used by the
FDA, is to expedite the Clearance/Approval of:
 510(k) Pre-market notification submissions
 De Novo submissions
 All Pre-market Approval Applications (PMAs)
 Proactive Product and Process Characterization and
Development Protocols
 All Investigational Device Exemption (IDE)
Submissions
 EUA Submissions
 Combination Investigational New Drug (IND)
Submissions
 All Biological License Applications (BLAs)
regulated by CBER
 All Q-Sub Meeting Requests, Reviews, and
Responses.
Use of electronic submission process enables the rapid
and seamless integration across and within each step in
the Medical Device Design Control and Manufacturing
Development Lifecycle and the EU-MDR 2017 for your
individual Device(s).

3. The seamless use of the electronic submission process
also requires proactive and early compliance with Design
Control and Data Standard Principles. These begin with
the Design Controls: Design Planning and/or EU-
MDR/IVDR 2017 Annex I and continue to be traced
throughout all other Design Data, Device History File
content and that compiled in the electronic submission.
As a result, successful utilization of the electronic
submission process requires proactive, early utilization of
510k Consultants, Medical Device Consulting, EU-
MDR/IVDR Consulting, and effective Q-Sub Meetings
to collectively result in FDA and Regulatory Body
Clearance/Approval.
Proactive utilization of the electronic submission process
via 510k Consultants, Medical Device Consulting, EU-
MDR/IVDR Consulting, and effective Q-Sub Meetings
will compliantly accelerate your seamless Device/Design
Data-Safety-Effectiveness-Risk-Rationale-Justification
integration across and within each step in the Medical
Device Design Control and Manufacturing Development
Lifecycle for your individual De Novo Device(s) as well
as any SE Device(s). essential to collectively result in
FDA and Regulatory Body Clearance/Approval.

4. Author Information
William E. Spanogle, Ph.D. has over 30 years of
management, full spectrum Regulated Life
Sciences, RA, QA (GCP, GLP. GMP), EU-MDR,
Design Controls. QMS, PMS, CSV/CSA, and R&D
experience. He is a published ISPE Invitational
author in Pharmaceutical and Biologics Product and
Process Development and has presented and
trained thousands of professionals on QbD, Design
Controls, Science-Risk Based Product
Characterization, and Risk Management at several
international conferences and numerous private
corporate sessions. Dr. Spanogle has taken scores
of Regulated Life Science Products from discovery
to pre-clinical and clinical trials, to approval and
launch; and audited, identified, and remediated QMS
deficiencies.
The opinions and statements in this blog are those
of the authors and do not necessarily reflect those of
BRG. This blog is based on personal experience
and reviews of information publicly available or
identified in other database searches.
Source: https://biotechresearchgroup.com/fda-
de-novo-medical-devices/