Bullet Proof 510(k) - Latest FDA Changes to the Process - Recorded Webinar

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Webinar Duration: 60 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: David R. Dills

OVERVIEW:
There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review process.

Product modifications that could significantly affect safety and effectiveness are subject to 510(k) submission requirements under 21 CFR 807 as well as design control requirements under the Quality System (QS) regulation. Under the QS regulation, all Class II and III devices and certain Class I devices are required to be designed in conformance to 21 CFR 820.30 Design Controls. FDA provides guidance and this course will address key resources when making critical decisions.

Objectives:
- Know the differences between the Traditional, Special and Abbreviated submissions
- Understand Substantial Equivalence and how it is applied
- Who is required to submit the application to FDA
- Where to submit the 510(k) and what to expect with the review and approval process
- When it is and is not required if you are a device company
- Exemptions to the submission process and special considerations
- How to locate a "predicate" device and go through the content and format of the 510(k)
- Understand the De Novo process and the expectations for possibly marketing a low risk device
- Understand the potential impact of FDA's proposed changes to the 510(k) process and why manufacturers need to pay attention

Detailed Agenda:
Introduction and Regulatory Background
- There is no 510(k) form; however, 21 CFR 807 Subpart E describes requirements for a 510(k) submission
- Current trends with the 510(k) process

The Process
- Who is Required to Submit a 510(k)
- When a 510(k) is Not Required
- When a 510(k) is Required
- Locating and justifying the Predicate
- Substantial Equivalence and demonstration of SE to another legally U.S. marketed device
- How to Prepare Submissions
- 510(k) Submission Methods
- List of forms associated with Premarket Notification 510(k) submissions
- Deciding When to Submit a 510(k) for a Change to an Existing Device
- What happens if FDA requires additional information and data and your responsibilities

Interactive Q&A, Wrap-Up and Adjourn
- Q&A with all attendees
- Group discussion and review of recent 510(k) clearances and proposals and recommendations between FDA and industry
- Discussion Points: some of the recommendations have included, but not limited to, redefining fundamental terms, limiting use of predicates, greater authority to rescind 510(k)s, etc.
- 510(k) Frequently Asked Questions
- Attendees should be prepared to address any issues and challenges as experienced on behalf of their company in this open-forum and interactive session

Who Will Benefit:
This course is appropriate to those involved in all aspects of the premarket notification, i.e., 510(k) process on behalf of medical device and In Vitro Diagnostic manufacturers. It is both a primer for personnel new to the FDA 510(k) process, or an excellent refresher course for those who need to revisit the basics and fundamentals for a better understanding on how to prepare and submit your application to ensure regulatory and compliance success. Those who will benefit include professionals in R&D, development, quality assurance and quality control, production,operations, engineering, compliance, and regulatory affairs and all levels of management, including technical and laboratory personnel who desire to understand what it takes to prepare and submit a bulletproof 510(k) to FDA while at the same time are aware of the changing regulatory landscape regarding FDA's proposed changes to the 510(k) process.


SPEAKER PROFILE:
David R. Dills,Global Regulatory Affairs & Compliance Consultant currently provides regulatory affairs and compliance consultative services for early-stage and established Class I/II/III device, IVD, biopharmaceutical, cosmetics and nutraceutical manufacturers on the global landscape, and has an accomplished record with more than 27 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities involving consent decrees, CIA’s, warning letters, and customer generated compliance events, conducts QS, regulatory, compliance assessments/audits and FDA Mock Inspections for State of Readiness.

He has been directly involved with constructing, reviewing, and remediating regulatory submissions, U.S. Agent for OUS companies, works closely with the key stakeholders and Agency/Center Reviewers regarding submission meetings and negotiations; clinical affairs/CTM and provides regulatory submissions and post-market project leadership and guidance covering multiple therapeutic and medical specialties based on classification. He has a strong background in the interpretation and applicability of FDA and international regulations, leads activities for the registration and approval process and working with the Agencies in Asia Pacific, EMEA and The Americas, including FDA, European Medicines Agency–EMA, MHRH, ANVISA, PMDA, MOH, CFDA, TGA, and Health Canada and works with management on regulatory strategies and plans supporting a company’s commercialization strategy. He directs and leads efforts for PM support involving all phases of the premarketing to postmarketing; establishes Medical Device Single Audit (MDSAP), UDI, and Digital Marketing/Promotion/Advertising compliance strategies; lead efforts regarding AE/Incident Reporting, all aspects of Postmarketing Surveillance and Vigilance Reporting; establish QMS and documentation systems for GxP compliance; ISO 13485 registration and CE Mark, Technical File, Design Dossier and CER consultation; and facilitates multi-country product registrations and licensing.

He recommends action to senior leadership to ensure effective resolution for manufacturers to achieve sustainable and proven compliant systems. Background encompasses broad capabilities in quality systems; documentation development and remediation; regulatory oversight and governance; design controls; CAPA investigations; GxP training; software embedded medical devices/all aspects of SW/SDLC and process validation with compliance oversight; supplier management; and demonstrates credible experience to optimize business performance through proactive strategies to mitigate compliance exposure. Mr. Dills has served on the Faculty Advisory Board for the Pharmaceutical Training Institute, Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology and on the Readers’ Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and was nominated and accepted for inclusion into the 2005-2006 Strathmore’s Who’s Who of Professionals.

Mr. Dills has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter. Mr. Dills’ academic degrees include Environmental Science and Biology. He is a former Chair and Co- Chair of ASQ’s Section 1506 and affiliated with the Biomedical Division, RAPS, AdvaMed, PDA, ISPE, and other industry working groups.

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