DE NOVO MEDICAL DEVICE APPLICATION PROCESS WITH TH 2016 - Fundamentals of the de novo process for medical devices: What you need to know when pursuing a de novo application and approval with the FDA - By Compliance Global Inc

Website https://complianceglobal.us/product/700467/ReginaBarrell/fundamentals-of-%20the-%20de-%20novo-proces | Edit Freely

Category Education; E-Learning

Deadline: July 20, 2016 | Date: July 20, 2016

Venue/Country: online webinar, U.S.A

Updated: 2016-06-28 18:28:03 (GMT+9)

Call For Papers - CFP

This webinar will describe the legal and regulatory basis for the de novo program and discuss the de novo device submission process. And provide information as to what constitutes a good quality de novo submission and will identify resources useful in preparing a de novo medical devices application.

Why Should You Attend:

The device approval process can be complex and time consuming and may not always result in obtaining FDA approval. Pursuing a Pre-Market approval or PMA approval for a new medical device can be especially costly and require substantial resource commitments. Knowing whether you can submit your device through the de novo process may result in cost savings not only in upfront resource burn but also in faster time-to-market for your medical device.

Areas Covered in this Webinar:

What is the definition of de novo? A brief history of the medical device regulations with respect to section 513 of the FD&C Act (device classification system)

Description of the de novo process (section 513(a)(1)) and the two pathways used to pursue FDA approval

Links to FDA guidance documents available and other useful references

Best practices and helpful hints to help facilitate the de novo process and submit a good quality application

Learning Objectives:

Will be able to understand the similarities, interrelationships, and differences between 510(k), PMA and de novo medical device approvals

The appropriate path to take when seeking approval of a new medical device or new indication for use of a prior approved device

The different pathways to interact with the FDA when pursuing a de novo application

Knowledge of section 513(a)(1) of the Federal Food, Drug and Cosmetic Act (FD&C Act)

Who Will Benefit:

Medical Device Professionals

Regulatory Affairs Managers

Corporate Device Managers responsible for submitting medical device applications for new devices or for new indications for use

Small Business Owners who will be submitting a device for approval with the FDA

Regulatory Consultants

For more information, please visit : https://complianceglobal.us/product/700467/ReginaBarrell/fundamentals-of-%20the-%20de-%20novo-process-%20for%20-medical%20-devices/1

Email: supportcomplianceglobal.us

Toll Free: +1-844-746-4244

Tel: +1-516-900-5515

Level:

Intermediate

Speaker Profile:

Recently retired after 29 years with the FDA, Regina was a senior compliance officer with the Office of Regulatory Affair (ORA) including over 7 years as a case review expert in the Office of Enforcement and Import Operations’ Division of Enforcement. Responsibilities included the review and analysis of complex, violative enforcement actions. Evaluated proposed advisory, administrative, and judicial actions for compliance with the Agency’s enforcement policy, regulatory objectives, and priorities, as well as determined the legal sufficiency of documented evidence.

As a field compliance officer for more than 14 years, she served as the senior legal officer in a District office, evaluating inspectional and analytical evidence to determine companies’ compliance with the FD&C Act and applicable regulations. Also served as a supervisory investigator, directing and overseeing the inspectional work of 10 investigators in an FDA field office.

As a course instructor for numerous FDA national courses, taught FDA compliance law to FDA compliance officers, field investigators, supervisors, Center and headquarter personnel and branch directors. Served as a member of FDA’s Device Field Committee, providing guidance and direction regarding ORA and CDRH work planning programs, deciding key areas for future inspectional and enforcement actions by FDA/CDRH with respect to medical devices.

Talks and presentations given to industry groups including RAPS, AFDO, the Medical Device Industry Coalition and the Colorado Biomedical Sciences group covered such topics as the Quality System Regulations, enforcement trends, and other current topics of interest to FDA-regulated industries.

Currently the Principal/Owner of Stonecroft Consulting, LLC, providing consulting services to medical device, pharmaceutical, dietary supplement, and other FDA-regulated industries.