Processes for 510(k) Clearances for In Vitro Diagnostic/IVD Device Products via FDA-CDRH

Discussion points:

• CDRH’s "Device-Advice" and "OIVD" Website Starting Ponts
• Importance of FDA’s Guidance Documents, of International Standards; and FDA Published "Summaries" of Previously Cleared/Predicate 510(k)s
• Registering Mfg Establishment & Listing of Devices
• Traditional Premarket Notification/PMN 510(k)s for Non-exempt Class 2 and Class 1 IVD Medical Devices
• Special 510(k) and Abbreviated 510(k) without changes to previous Indications for Use
• Relationship to Eventual & Direct FDA Inspection to "Design Control" Components of FDA’s Reqired "Quality System Regulations" [i.e., especially to Indications for Use and IVD Device Labeling]
• "De Novo" IVD Submissions [i.e., NO Direct Predicate] Require Premarket Approval /PMA, a more Lenthy Process

• IVD Validation & Clearance [as described above]
• Why IVDF validation makes good business sense
• The top 10 errors in IVD device validation
• What procedures are required and where to get them
• What approaches you can use: prospective, concurrent, and retrospective
• How to validate new systems with a prospective validation process
• How to validate existing systems using a combination of concurrent and retrospective validation
• What are the minimum deliverables that I must create

Who will benefit:

This webinar will provide valuable assistance to all regulated companies that need to validate their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

• End-users responsible for applications that need to be validated re: IVD devices
• QA managers and personnel
• IVD & Biotechnology managers and personnel
• IVD & Biotechnology Validation specialists
• IVD Consultants
• IVD Quality System auditors

Instructor Profile:

Alfredo J Quattrone, Ph.D., is a Senior Compliance Scientist with Auk Technical Services, Inc. (ATS), a California-based consulting firm that specializes in quality systems for IVD device & biomedical drug companies, especially review & validation of in vitro diagnostics /IVD firms. Dr. Quattrone previously served as a Third Party Reviewer for FDA and over the last 6+ years successfully reviewed 35+ PMN submissions for 510(k) clearance through Dec. 2006, when he retired from CA State service. Dr. Quattrone is also certifed in ISO 13485 inspections and has collaborated with Mr. Dennis Moore, CEO of ATS, in writing a detailed set of policy and procedural documents and templates for use by in vitro diagnostic, drug and biological/biomedical firms for systems validations, available via ATS, Inc.

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