This class reviews the modular option of filing a PMA and the benefits it offers all companies having to negotiate through the PMA process.
Most Class III devices require Premarket Approval (PMA) prior to marketing the device in the United States. This class reviews the modular option of filing a PMA and the benefits it offers all companies having to negotiate through the PMA process.
Areas Covered in the seminar:
- Why a modular PMA.
- Modular PMA agreement with the FDA.
- Organizing each Module.
- Review time for each module.
- Manufacturing Module.
- Clinical Module.
- Class Audit of Manufacuring Facility up to 17 days.
Who will benefit:
This webinar is directed at all device, blood and biologist companies facing the PMA process and how best to dispense with each topic as the module is completed. Who will benefit:
- Sponsor
- Regulatory Manager
- Clinical Specialist
- Venture Capitalist
Instructor Profile:
E.J. Smith, is a co-founder of Smith Associates, a FDA regulatory consulting firm that specializes in the preparation of 510(k), PMA and IDE submissions, device and cosmetic labeling, quality system audits and clinical trials. E.J. is the author of Hospital Consumables and Smith’s Reference and Illustrated Guide to Surgical Instruments and has 43 years of experience in medical marketing, executive positions and FDA regulatory affairs.
