Preparing and Submit a Compliant 510(k) Submission

    /David  /R. Dillsspeaker of Training Doyens
    Speaker: David R. Dills


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    Duration: 60 Minutes
    Product Code: 50240
    Level: Beginner

OVERVIEW

Since September 2009, the Centre for Devices and Radiological Health has been reviewing the operation of the 510(k) program and the way CDRH uses science in the decision making process. In August 2010, the 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making each released a preliminary report with a series of recommendations. Overall, industry has provided mostly a positive response but with exceptions. The proposals are more benign than many had feared. No radical change to the current process appears likely. Bottom line, FDA issued two comprehensive evaluations containing recommendations that address three key objectives of the agency’s public health mission as it relates to medical devices – foster device innovation, create a more predictable regulatory environment, and enhance device safety.

WHY SHOULD YOU ATTEND

This webinar provides an overview of the premarket notification process and all of the critical and key steps required to ensure you prepare and submit a well-constructed 510(k). Provides an overview of the 510(k) Program including the basics of how to prepare and submit a 510(k) to the FDA and recent changes and trends. There is no 510(k) form; however, 21 CFR 807 Subpart E describes requirements for a 510(k) submission. Before marketing a device, each submitter (the applicant) must receive an order, in the form of a letter, from FDA which finds the device to be substantially equivalent (SE) and states that the device can be marketed in the U.S.

AREAS COVERED

  • Statutory Requirements and Expectations
  • When a 510(k) Is Required and Not Required
  • Who is Required to Submit and Who is Exempt
  • Device Classification
  • Forms Required and to be Used 
  • Submission Methods: Log-In, Review Process and the Decision Letter 
  • Traditional/Special/Abbreviated 510(k) Submissions
  • Find and Use the Right Predicates
  • Pre-Sub (Q-sub) Approach and FDA Meetings
  • Substantial Equivalence: Factors to Consider and Special Considerations
  • Requests for Additional Information and How to Respond Effectively to the Reviewer
  • Is a New 510(k) Required for a Change or Modification to My Device 
  • Recent FDA Deficiency Categories for 510(k) Submissions and Pitfalls to Avoid
  • Recent FDA Final 510(k) Guidance
  • 510(k) Gap Assessment is Crucial Before Submitting
  • e-Copy and RTA Policy Requirements
  • Mistakes for eCopy and RTA Policy Requirements
  • FDA’s Timeline for Receiving Your Submission to Marketing Clearance
  • Redefining terms such as Intended Use/Indications for Use, limiting use of predicates, consideration of off-label uses, greater authority to rescind 510(k)s and other changes
  • Recommendation for a new subclass of Class 2 products for which clinical studies will be required
  • The de novo process could streamline the clearance process
  • Obtain latest recommendations and comments from various device trade groups
  • What additional costs might device makers face in light of new regulatory requirements? 
  • What will the proposed changes mean for the number of devices cleared? 
  • How will the proposed changes affect so-called "split-predicates" and other considerations? 
  • What is the regulatory process for implementing the recommendations? 
  • What can device companies do to prepare for changes? 
  • 510(k) Frequently Asked Questions by You – Industry
  • Latest Trends with 510(k) Submissions and FDA

LEARNING OBJECTIVES

This webinar will provide valuable assistance and guidance to medical device and IVD companies involved in any aspect of the 510(k) process.

WHO WILL BENEFIT

  • All levels of management and departmental representatives any anyone who desire a better understanding or a "refresh" overview of the 510(k) process 
  • CRO’s 
  • Regulatory Affairs/RA Specialists
  • Clinical Affairs
  • Project Leaders
  • Quality and Compliance
  • Marketing & Sales 
  • Distributors/Authorized Representatives
  • Engineering/Technical Services/Operations
  • Consultants

SPEAKER

David R. Dills, Global Regulatory Affairs & Compliance Consultant, Interim President, currently provides global regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III medical device, including combination products, In Vitro Diagnostics, nutraceuticals/supplements, cosmetics and biopharmaceutical manufacturers in multiple medical specialties and therapeutic areas on the global landscape, and has an accomplished record with more than 26 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities and services involving consent decrees, CIA’s, warning letters,483 observations, and customer generated compliance events, and prepares for and conducts QS and regulatory audits. He is currently acting and interim President at NovaQual LLC. 

He has been directly involved with constructing, reviewing, and/ or remediating regulatory submissions, including 510(k), PMA, IDE applications, IND, BLA and NDA submissions, preparing responses to AI’s/deficiency letters, Supplements, Amendments, acting U.S. Agent, works closely with the key stakeholders and Agency/Center Reviewers regarding submission meetings and negotiations; clinical affairs and study submissions; and provides regulatory submissions and post-market project leadership and guidance covering different therapeutic and medical specialties based on classification. 

Mr. Dills has a strong background in the interpretation and applicability of FDA regulations, including 21 CFR 210/211, 820 QSR/cGMP, Quality System implementation and compliance requirements, GxP training, leads and directs activities for the registration and approval process and working with Agencies in Asia Pacific, EU and The Americas, including but not limited to FDA, European Medicines Agency–EMA, MHRH, ANVISA, PMDA, MOH, SFDA, TGA, and Health Canada; and defining and executing regulatory compliance, risk mitigation and remediation strategies in response to inspection findings. Additional activities include Pre-FDA Facility Inspections, Mock Audits/Due diligence and assessing state of readiness for Pre-approval inspection (PAI/PMA), proof of management oversight, facilitate and direct efforts for remediation planning and monitoring, and assessment of the critical sub-systems, records and document controls; and strives for reduction of regulatory compliance risk for companies. 

Directs and leads efforts for PM support and consultative services on behalf of manufacturers and subcontracted by third-party consultancies and provides services involving all phases of the product development, submission, and commercialization process from premarketing to post marketing; retained as U.S. Agent for international pharma and device clients; conducting supplier and QS audits/assessments; UDI compliance strategies; establishment registration and listing; Agency inspection readiness preparation and remediation; preparing Agency responses due to enforcement actions; conducting GxP audits and preparing CAP/remediation plans; compliance engineering support; support and/or lead efforts regarding Adverse Event, MDR, Incident Reporting, Post marketing Surveillance and Vigilance Reporting; clinical affairs, establish and/or remediate Quality Management and documentation systems for GxP compliance; preparation for ISO13485 registration and CEMark; and multi-country product registrations and licensing.

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