Online Webinar 2019 - Developing premarket approval packages for innovations which are more effective in reducing potential adverse events; MAUDES; and or recalls particularly FDA class recalls

Premarket Approvals Premarket approval (PMA) are required by The Food and Drug Administration is the regulatory protocol presently used to evaluate the safety and effectiveness of Class III medical devices, e.g., an implantable cardioverter defibrillator (ICD). PMAs are a rigorous in nature and can take several years to complete. PMA is the most stringent type of device marketing application required by FDA. The applicant must receive FDA approval of its PMA application prior to marketing the device. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s)”. Class III are medical devices which “usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. Examples of Class III devices include implantable pacemakers and breast implants. 10% of medical devices fall under this category.
Session Highlights
510K
Premarket Approval (PMA) Package
Stream-lining efforts to comply with PMA requirements required by the PMA for their class III
Optimizing your PMAs to reduce adverse events
FDA class III device design controls
Preparing PMA packages
Types of Medical Device Defects
Adverse medical device events, e.g. MAUDEs, MDRs
Why one should attend the training
• Understanding changes to the 510K process
• Understanding the minimal portions of Premarket Approval (PMA) Packages required
• Stream-lining efforts to comply with PMA requirements required by the PMA for their class III
• Understanding FDA class III device design controls
• How to prepare more effective PMA packages to reduce adverse medical device events, e.g. MAUDEs, MDRs
• How to prevent FDA device adverse events using such tools as DFSS
Who Will Benefit
Clinical Trial Physician / Doctor
Manager to Senior Director of
Regulatory Affairs
Quality Assurance
Clinical Research
Data Management
Data Monitoring
Speaker
Dr. George Yanulis has consulted in Medical Device Product Development and Research for 20 years and has a Doctorate and Master’s Degree in Biomedical Engineering. He has conducted cardiovascular device research at the Cleveland Clinic Foundation on cardiac pacing paradigms used in heart failure patients. In addition, Dr. Yanulis has been involved in the R&D Medical Device Consulting & Litigation Support as an Expert Witness for over 10 years and has been involved in numerous medical device liability and patent infringement cases. He provides expertise to attorneys, medical device companies, health care systems and insurance carriers related to FDA medical device controls, PMAs, post-market surveillance issues, medical device/product failures and IP medical device issues. In addition, he has reviewed MDR(s) and other adverse events related to implant device failure. Dr. Yanulis is highly motivated in maintaining and providing the highest level of quality in the design, development and safe and effective use of all types of cardiac device implants.