Preparing for and Responding Effectively In a Positive Manner to an FDA Postmarket Surveillance Visit

Why Should You Attend:

FDA may order postmarked surveillance to better understand the nature, severity, or frequency of suspected problems reported in adverse event reports or in the published literature. FDA may order post market surveillance to obtain more information on device performance associated with real-world clinical practice. FDA may order post market surveillance to address long term or infrequent safety and effectiveness issues for implantable and other devices for which the premarket testing provided more limited information. For example, premarket evaluation of a device may have been based on surrogate markers. Once the device is actually marketed, post market surveillance may be appropriate to assess the effectiveness of the device in detecting or treating the disease or condition, rather than the surrogate. Data collected through post market surveillance may include rates of malfunction or failure of a device intended for long-term use or incidents of latent sequelae resulting from device use.

FDA may order post market surveillance to better define the association between problems and devices when unexpected or unexplained serious adverse events occur after a device is marketed, if there is a change in the nature of serious adverse events (e.g., severity), or if there is an increase in the frequency of serious adverse events.

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) system.

All medical device manufacturers who are involved in preparing PMAs for their class III device should attend this training session. This seminar will allow them to better understand the nature, severity, or frequency of suspected problems reported in adverse event reports or in the published literature. The information is most effective in reducing potential adverse events.

Areas Covered in the Webinar:

• PMA preparation
• Adverse FDA events
• Post Market Surveillance
• Current Good Manufacturing Practices for medical devices
• Complaint Handling
• Current ISO regulations applicable to medical devices
• Responding to FDA to CAPAs
• FDA advisory, Medical Device Recalls

Who Will Benefit:

• Medical Device Manufacturers who are involved in quality assurance monitoring; research and development personnel as well as manufacturing personnel.
• Medical device manufactures involved in preparing 510ks; PMAs, Medical Device Audits for class III devices.

Free Materials:

• Rule documents or guidance
• Checklist
• SOP template
• Easy fill in forms
• Articles

George Yanulis
President, Medical Device Consulting LLC

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.

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