Medical Device Submissions Series: Premarket Approval (PMA) Workshop

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 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 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.    

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. 

Jessica Ringel advises medical device and other life sciences manufacturers and distributors on matters spanning the entire FDA regulatory lifecycle.  She advises clients on premarket regulatory strategy by assessing pathways to market, identifying predicate devices for 510(k) submissions, preparing q-submissions to receive FDA feedback, and assisting clients with the preparation and submission of marketing applications, including 510(k)s, De Novos, and PMAs.  After clearance or approval of a device, Jessica advises clients on the full range of post-market compliance matters.  She assists firms in preparing for and managing FDA inspections, responding to FDA-483s and Warning Letters, and implementing quality system corrective actions and remediation plans. 

Jessica also advises clients on product recall strategy and communications and adverse event reporting obligations.  Jessica has also worked with multiple clients on the negotiation of, and operations under, consent decrees of injunction with FDA.  She further assists life sciences firms with the review and development of compliant marketing strategies and materials.  She assists clients with FDA-related import matters, including by responding to import detentions to obtain the release of products held by FDA.  Jessica also advises companies that process and distribute human tissue-based products (HCT/Ps) and that manufacture and distribute electronic products subject to FDA’s electronic product radiation control program.    

Jeff has 30 years’ experience in US medical device law and regulation.  He counsels firms in regulatory strategy and filings, including presubmissions, clearances, approvals, breakthrough designations, and internal agency appeals.  He helps firms develop a sound regulatory strategy for bringing their medical devices through US FDA review, to draft the relevant submissions, and to respond to FDA’s requests for information and data.  When advising start-ups and mid-sized manufacturers, Jeffrey recognizes the business considerations involved in creating regulatory strategies and managing compliance.  His mission is to bring companies through the FDA process as efficiently and expeditiously as possible.  Jeffrey also counsels companies on post-market compliance, such as reporting to FDA, complying with the quality system regulation, labeling and advertising compliance, recalls, inspections, and warning letters, and he is an expert in FDA’s regulation of combination products (e.g., drug-device combinations). 

Jeff is a national authority on FDA’s regulation of medical devices, combination products, and HCT/Ps.  He actively contributes to industry conversations on FDA regulation of medical devices. He has published hundreds of articles on various topics relating to FDA’s regulation of medical devices. 

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.  He represented the CDRH Innovation Team as a founding member of the Center’s Payor Communications Task Force, which provides opportunities to improve patient access to innovative medical devices important to public health by engaging manufacturers, payors, and healthcare technology assessment organizations.  He has led a variety of special projects and has worked in various other roles, including pre-market review and compliance enforcement.