Navigating the 510(k) process

12:00 PM ET | 09:00 AM PT | 11:00 AM CT Duration 60 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 60 mins Live Webinar

"Thomas Bento is a student of Quality and Regulatory Compliance"

Simplified defensible approach to a successful submission


This presentation will de-mystify the Pre-Market Notification process (510(k) by walking you through the personal experience, current regulation, regulatory expectations and the latest FDA thinking and guidance documents to assist the manufacturers in enhancing the predictability, consistency, and transparency of the supporting guidance’s for 510(k) submissions of 510k. This includes but is not limited to "when to submit" decision-making process by providing a least burdensome approach, and describing in detail the regulatory framework, policies, and practices underlying such a decision. 

Why Should You Attend

The process is complicated, but I will give you a simplified defensible approach to a successful submission. I will provide examples and recent experiences over many different product types.

Areas Covered

• The “Application” process.

• The 510(k) process steps from A-Z

• Predicate selection

• BioCompatibility

• Determine whether the intended change(s) to labeling, technology or materials, significantly affect the safety or effectiveness of an existing device, or its intended use

• Substantiate and document decisions as to whether new 510(k) is or is not required

• Apply FDA's risk-based assessment for modified devices to achieve least burdensome approach

• Present 3 hypothetical examples that FDA uses to illustrate the process of determining when a 510(k) is required and how to document the decision

• The role of validation & verification to determine whether a change could significantly affect device safety and effectiveness

• Substantial equivalence determination

Who will Benefit

• Quality Managers

• Quality Engineers

• Regulatory Affairs

• Small Business Owners

• GxP 

• Consultants

• Quality VPs

• Lab Directors

• FDA Investigators

• Other Regulatory Agency Investigators 

Industries who can attend

This 60-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.

Speaker Profile

Thomas Bento

Thomas Bento is a student of Quality and Regulatory Compliance and has been supporting the design, development and compliance of Medical Device Manufacturing for 17 years. He started his career training in Software engineering and shortly moved into Commercial Software Quality. After many years of working for companies like Mitek Systems and Hewlett Packard, the decision was made to work in the regulated space of Medical Device Manufacturing, working at Edwards, Pulmonetic Systems, Regulatory consulting and SVP at Nihon Kohden America. Now he is Consulting for Philips Medical Systems. Through his experience he has found that the common thread that runs through the fabric of most Medical Device Manufactures is that more is better in order to meet regulatory expectations. He finds that this is the exact opposite and that manufacturers are better off by cultivating a simplified defensible approach to regulatory compliance founded on understanding and addressing Risk Management Appropriately.

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