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/