How to Prepare and Submit a Bullet Proof 510(k) Submission

A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA. 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 session will address key resources when making critical decisions.

Areas Covered in the seminar:

• Know the differences between the Traditional, Special and Abbreviated submissions.
• Understand Substantial Equivalence and how it is applied .
• Who is required to submit the "submission" to FDA l.
• Where to submit the 510(k) and what to expect with the review and approval process.
• Where and 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.

Who will benefit:

This webinar will provide valuable assistance and guidance to all medical device companies that are preparing and submitting 510(k)s to FDA for review and approval. The employees who will benefit include:

• All levels of Management and personnel from all departments who desire to learn how this process works
• QA/QC/Compliance/Regulatory Affairs
• Engineering/R&D/Technical Services
• Marketing
• Consultants
• Operations/Manufacturing/Validation

Instructor Profile:

David R. Dills, Senior Consultant with PAREXEL Consulting has more than 19 years of hands-on and direct experience in quality, quality systems, regulatory affairs, compliance and validation within the life sciences and FDA regulated industry. David has been previously affiliated with well-known manufacturers and service providers and has served in various quality, regulatory and compliance management and advisory capacities with increasing responsibilities. David is global industry speaker and author of technical and compliance related topics published in industry journals. Please refer to his biography provided herein for additional information about his background and areas of expertise.

ComplianceOnline is a Regulatory Affairs Professionals Society(RAPS) RA Professional Development Portal provider. ComplianceOnline is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs ComplianceOnline has agreed to follow RAPS-established operational and educational criteria..Credit available for Live webinar Attendees only.

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