2018 FDA Guidelines for 510(k) Submission

01:30 PM EDT | 10:30 AM PDT | 12:30 PM CDT Duration 60 Minutes

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

"Listen From Dr. David Lim, Ph.D., RAC, ASQ-CQA. Recently, He developed 510(k) templates ready for use compliant with e-Copy and RTA policy."

Process leading to timely clearances


This webinar is intended to provide practical and actionable guidelines on premarket notification [510(k)] preparation and submission to the US Food and Drug Administration (FDA).

The section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) prescribes the premarket notification requirements.  510(k) is the most common pathway to bring medical devices including in vitro diagnostic medical devices (IVDs) into the US market.  

To obtain a clearance, the 510(k) is first submitted to the US FDA, demonstrating that the subject device (to be marketed) is substantially equivalent to a legally marketed device(s) (predicate device) as described in 21 CFR 807.92(a)(3).  In other words, firms must demonstrate that a proposed product is substantially equivalent to another, a legally marketed medical device that is also lower-risk and is not subject to premarket approval (PMA). Over time, the 510(k) program has significantly evolved, affecting the 510(k) decision-making process.

To expedite the process of bringing a product to market through the 510(k) program, it is imperative that the medical device manufacturers understand the statutory requirements to expedite the FDA review process leading to timely clearances. 

In this 60-min webinar, the speaker will walk you through common mistakes, recent trends and customized strategy for a successful clearance. The speaker will further discuss how to improve submission quality, preventing avoidable delays and reducing review times. 

Areas Covered

•    Statute(s) and Regulations

•    Definitions

•    Guidelines for 510(k) Requirements

•    Selecting a Predicate Device

•    510(k) and De Novo Process

•    How To Demonstrate Substantial Equivalence

•    510(k) Contents And Format

•    Addressing Technical and Regulatory Requirements.

•    510(k) Submission Quality

•    Responding to FDA’s Request Of Additional Information

•    How to Resolve Different Opinions and What Process to Take

•    Avoiding Common Mistakes with Awareness

•    510(k) Trends

•    Best Practices for 510(k) Preparation and Submission: Dos and Don’ts

•    Speaker’s PASS-IT Recommendations

Who will Benefit

•    Regulatory associates, specialists, managers, directors and VPs

•    Clinical associates, specialists, coordinators, managers and directors

•    Quality associates, specialists, engineers, managers, and directors

•    R&D associates, scientists, managers, and directors

•    Site managers, and consultants

•    Other stakeholders interested in 510(k) preparation and submission

Industries who can attend

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

Speaker Profile

Dr. David Lim Ph.D., RAC, ASQ-CQA

Dr. David Lim, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us).  As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings.  Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009. 

Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.

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