Mr. E. Wreh
Hands-on regulatory affairs professional with extensive in Premarket Notification [510(k)] submission.
What is that?
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA.
Quality Management System Audit/Inspection, Medical Device Reporting (MDR), CE Technical File, Notified Bodies Surveillance Audit, EU Medical Device Directive (MDD), Pressure Equipment Directive (PED).
What is (MDD)?
Directive 93/42/EEC of the European Union (EU) (also known as the Medical Devices Directive - MDD) details the Essential Requirements manufacturers and importers must meet to apply the CE mark and legally market or sell their devices in the EU.
Health Canada: New License Application, Health Canada Medical Device Regulations, Therapeutic Goods Administration (TGA). Oversee Health Canada, FDA and Notified Bodies audit and inspection, including providing regulatory counsel to the Senior Executive Management team and create high-performance teams, cross-training employees and fostering a goal-focused environment. Continuously improve processes to achieve better results.
What is HCMDR?
Canadian Medical Devices Regulations: Manufacturers of medical devices that intend to sell devices and importers and distributors of devices in Canada must comply with the most current version of the Canadian Medical Devices Regulations
China: China Food and Drug Administration (CFDA), Regulatory Due Diligence, Medical Device State License Registration and new product development introduction in both government and industry settings. Interprets guidance and laws in the area of medical device evaluation and regulation.
PROFESSIONAL EXPERIENCE: FDA Medical/Neurology.
Industry Representative, FDA Advisory Committee Neurological Devices Panel 04/2017 – present
• Review and evaluate data concerning the safety and effectiveness of marketed and investigational devices for use in the neurological system and makes appropriate recommendations to the Commissioner of Food and Drugs
• Help the FDA obtain independent expert advice on scientific, technical, and policy matters for Neurological Devices.
Regulatory Affairs Manager (Pre-market), Invacare Corporation 04/2015 – present • Responsible for regulatory filing for new and existing products to the FDA, European Union Notified Bodies, Health Canada, CFDA and TGA.
Review product labeling (i.e., user manual, service manual, marketing literature and brochure)
• Develop and maintain documented regulatory procedures
• FDA Annual Establishment Registration & Device Listing, Health Canada Annual Medical Device Establishment License registration and State Annual Medical Device registration.
• Corporate Unique Device Identifier (UDI) Regulatory Affairs Lead.
• Coordinates actions with the FDA for medical devices Import Alerts and Detention Holds Key Accomplishment:
• Successfully helped Invacare Corporation satisfy the FDA’s requirements under the Consent Decree to manufacture and sell products without restriction.
• Remediated several 510(k) submissions affected by the FDA Consent Decree
• Remediated Design History Files (DHF) for products in scope of the FDA Consent Decree
• Remediated CE Technical Files for Class IIa, IIb devices and Health Canada Class II devices
• Negotiated with FDA in resolving several FDA 483 Warning Letters and Import Detention Alerts
• Ensured all products meet the FDA UDI requirements and compliance dates
• Authored several Premarket Notification [510(k)] submissions, [510(k)] Pre-Submissions, CE Technical Files and Health Canada License Applications for new and existing products
• Managed several FDA inspections/audits, Notified Bodies Surveillance audits, and Health Canada inspections
• Successfully transferred several medical devices manufacturing facilities and Design History Files (DHF) from Canada to Mexico and from China to the United States
• Worked with FDA Imports Branch to resolve removing several medical devices from import alerts and detention holds
Senior Regulatory Affairs Specialist, Stryker Trauma & Extremities
• Successfully implemented FDA UDI requirements for Trauma & Extremities products
• Participated on several new product development introductions
• Introduced human cells, tissues and cellular and tissue-based products (HCT/Ps) in interstate commerce from Original Equipment Manufacturer (OEM)
• Reviewed orthopedic device labeling (i.e., advertising, marketing, and promotional materials)
• Successfully authored ten Premarket Notification [510(k)] submissions and two [510(k)] Pre-Submissions for Trauma & Extremities Orthopedic devices
• Represented Stryker Corporation at the AdvaMed UDI Orthopedic Kit Working Group meeting with the FDA at the Center for Devices and Radiological Health in Silver Spring, MD. The FDA provided exemption for Orthopedic Kits manufacturers after the face-to-face meeting.
• Provide strategy development, analysis and recommendations to individuals and organizations in a wide variety of regulatory affairs issues.
• FDA regulated devices and combination products, including in-depth knowledge and understanding of FDA expectations, requirements and regulations for device submissions; preparation and/or review of device submissions including 510(k), and PMA; EU CE Mark Medical Device Directive (EU Technical File and Design Dossiers, and Change Notification) to EU Notified
• Authored one (1) Premarket Notification [510(k)] submission, updated five (5) EU Technical Files, two (2) Design Dossiers, Annual Registration and Medical Device Listing
• Represented Regulatory Affairs on several company projects.
• Communicate regulatory requirements and the impact of regulations to the Vice President of Regulatory Quality and Regulatory and the New Product Development Team
• Participated in FDA Audit and Inspection, European Union Notified Bodies Surveillance Audit and Supplier Audit
Food and Drug Administration (FDA), CDRH Medical Device Fellowship Program 7/2011 – 9/2011
• Facilitated the writing of the FDA 2011 Draft Guidance Document on processing and reprocessing of medical devices in health care settings.
• Developed and presented a technical report on guidelines and standards on how to reprocess reusable medical devices to staffs of the Center for Devices and Radiological Health (CDRH)
• Reviewed 510(k), Premarket Approval (PMA), Investigational Device Exemption (IDE) and Medical Device Reporting (MDR) submissions.
• Helped 510(k) reviewers at CDRH developed a checklist when reviewing for reusable medical devices.
• Ensured and reviewed regulatory documents and supervised regulatory files • Made sure that regulatory submissions were completed and in compliance with FDA Standards • Helped regulatory team observe applicable laws, regulations and guidance documents • Coordinated international regulatory standards and performed regulatory research.
Quality Control Chemist, Minntech Corporation
• Analyzed raw materials and finished products, using analytical chemistry techniques, ensured that clinical sites had needed tools and equipment for clinical trials and provided investigative support for successful product development.