Medical Device Submissions Workshops – Premarket Approval (PMA)

Jhumur Banik, PMA Policy Analyst, HDE, Q-Submission and Device Tracking Lifecyle (PHQ) Team, Division of Submission Support (DRP1), Office of Regulatory Programs (ORP), CDRH, FDA 

Jhumur Banik, MS, PMP is a Policy Analyst with the PMA, HDE, Q-Submission and Device Tracking Lifecyle (PHQ) Team in the Division of Submission Support (DRP1), Office of Regulatory Programs (ORP) in FDA/CDRH. She is involved in policy development and providing her regulatory and technical expertise on PMAs, PMA GMP, and Q-submissions for internal and external stakeholders among various other duties. Previously, she was a Lead Reviewer/Biomedical Engineer with Office of Health Technology 2 where she conducted numerous lead and consulting reviews while also contributing to the standards and guidance development efforts in the cardiovascular devices space. Before joining FDA, she worked in Regulatory Affairs for medical device manufacturers. She received her BS and MS degrees in Biomedical Engineering from Rensselaer Polytechnic Institute (RPI) in NY.  

Tony Blank, Senior Director of Regulatory Affairs, AtriCure 

Tony Blank is the Senior Director of Regulatory Affairs at AtriCure. He is formerly the cofounder of Barton & Blank, a regulatory consulting firm specializing in providing strategic and tactical regulatory support for medical devices and combination products. Previously, Blank spent 12 years at Boston Scientific Corp. Under his leadership of the cardiovascular regulatory teams, Boston Scientific obtained numerous regulatory approvals for cardiovascular medical devices and combination products—among these being worldwide regulatory approvals for drug-eluting stents, implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRT-D), cardiac pacemakers and cardiac resynchronization therapy pacemakers (CRT-P), and detachable coils for peripheral embolization. Blank has been an active representative for the medical device industry and the regulatory profession on numerous policy issues working with AdvaMed. Among these activities has been participation in numerous Industry Working Groups including the Pediatric Devices, Advertising and Promotion, and Reprocessing Working Groups (each of which he co-chaired). 

Jennifer Bolton, Senior Fellow, Regulatory Affairs, Boston Scientific 

Jennifer Bolton is a Senior Fellow, Regulatory Affairs, at Boston Scientific Corporation.  Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world, specifically with less-invasive technologies engineered to diagnose and treat a wide range of medical conditions.  

Jennifer has 30 years’ Regulatory experience.  She’s led key market and clinical approvals for many cardiovascular and peripheral products including the ACURATE neo2 Aortic Valve System and the WATCHMAN Left Atrial Appendage Closure Device.  She also works with integration projects, combination product projects, serves on the MDIC ENRICHMENT Industry Advisory Council, volunteers with a local Medtech Accelerator for early-stage start-ups, and is an Adjunct Instructor for the St. Cloud State University Regulatory Affairs and Services master’s program.   

Jacob Dyer, Senior Regulatory Officer, FDA

LCDR Jake Dyer serves as a Senior Regulatory Officer within the Regulatory Inspections and Audits Team at the Center for Devices and Radiological Health (CDRH), Office of Regulatory Programs. In his current role as a Program Analyst and Assessor for the Medical Device Single Audit Program (MDSAP), he leads initiatives focused on the program’s development and implementation in collaboration with international regulatory authorities and industry stakeholders.

With over eight years of experience at the FDA, Jake began his tenure as a Medical Device Investigator. He is a licensed Professional Engineer and holds multiple certifications, including Lean Design for Six Sigma Black Belt, Project Management Professional (PMP), Certified Quality Auditor, and Level 2 FDA Medical Device Investigator. LCDR Dyer earned a Bachelor of Science in Mechanical Engineering and a Master of Science in Data Science.

Ken Skodacek, Center for Devices and Radiological Health, Deputy Ombudsman, FDA

Ken Skodacek has been working with medical devices for over 30 years and serves as the Deputy Ombudsman for FDA’s Center for Devices and Radiological Health (CDRH).  In this role, Ken provides a confidential, independent, and impartial resource that informally investigates complaints and resolves disputes.  He typically prevents and resolves misunderstandings through candid conversations and facilitated meetings with external stakeholders and FDA staff. The CDRH Ombudsman Program also ensures fair and efficient processing of appeals of CDRH decisions. Outside of his responsibilities at FDA, he has served as the Co-Chair of the American Bar Association’s Ombuds Committee and is an active member of the Coalition of Federal Ombudsman and the United States Ombudsman Association. 

He previously served in the Center’s Clinical Trials Program, where he led the development and implementation of policies and programs intended to improve the quality, efficiency, and consistency of the Investigational Device Exemption (IDE) submission and review process. 

Elaine Tseng, Counsel, King & Spalding 

Elaine Tseng focuses on regulatory matters in the area of life sciences. A partner in our FDA and Life Sciences practice, Elaine represents medical device, pharmaceutical and other life sciences sector clients in a variety of regulatory strategy, approval, marketing, compliance and enforcement matters. 

Elaine primarily represents clients in matters involving the Food and Drug Administration. She provides proactive regulatory strategy and compliance counseling, including in the areas of FDA marketing clearance/approval and exemptions, clinical studies and product development, adverse event reporting, recalls, and other pre- and post-market compliance obligations. Elaine advises on managing FDA inspections, responding to FDA-483s and warning letters, interacting with FDA on compliance and product review matters, pursuing regulatory appeals and petitions and participating in FDA Advisory Committee deliberations. Elaine has extensive experience conducting FDA regulatory due diligence assessments in connection with corporate transactions, handling internal investigations involving FDA issues, and conducting audits and assessments of compliance with FDA requirements regarding quality systems/cGMP, clinical trials, and marketing and promotion. She also advises companies on structuring business transactions and ventures to minimize regulatory risk and potential compliance concerns.