This seminar 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 seminar, 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 in the Session

• 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

Target Companies:

• Johnson & Johnson
• GE Healthcare
• Medtronic
• Baxter International
• Siemens Healthcare
• Philips Healthcare
• Cardinal Health
• Covidien
• Abbott Labs
• Stryker
• Danaher
• Becton Dickinson
• Boston Scientific
• Essilor
• Alcon
• B. Braun
• Fresenius 
• St. Jude Medical
• 3M Healthcare
• Olympus Medical
• Zimmer
• Smith & Nephew
• Hospira
• Terumo
• CareFusion
• Getinge Group
• C.R. Bard
• Biomet
• Varian Medical
• Bayer