Online-Seminar Medical Devices in the USA From Approval to Reimbursement

Zum Thema

Topic

The Food and Drug Administration (FDA) is the regulatory body responsible for a wide range of products, including food, drugs, and medical devices. Its task is to protect and promote public health in the USA. The FDA oversees the safety and effectiveness of human drugs and medical devices. This applies to products manufactured in the USA as well as imported products.

Manufacturers of most Class II medical devices (according to US classification) must submit an FDA 510(k) application. To obtain marketing clearance for a product from the FDA, a comparable product that has already been cleared by the FDA must first be identified. This product must be similar to the one being applied for and intended to be cleared by the FDA. Extensive evidence must then be provided.

The seminar provides an insight into the American healthcare system and medical device regulations and offers practical guidance on preparing and formally submitting applications. For participants who are interested, the meeting will involve a discussion of up to six case studies of actual products in development along with some key advice on how to proceed.

The Online-Seminar will be held in English.

Zielgruppe

Target group

The seminar is aimed in particular at representatives of medical technology companies who are active or would like to become active in international trade and procurement. The seminar will be held in English.

Referenten

• Liz Munro
  Vice President, Regulatory and Advisory Services
  Avania | Toronto
  
• Stephen Hull
  Sr. Vice President, Market Access & Reimbursement
  Avania | Boston
  

Moderation

• Tina Wilke
  Consultant BVMed-Akademie
  Bundesverband Medizintechnologie e.V. (BVMed) | Berlin
  

Programm

Teilnahmebedingungen