Orphan Devices: Humanitarian Device Exemptions and Humanitarian Use Designations

An Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. A device manufacturer`s research and development costs could exceed its market returns for diseases or conditions affecting small patient populations. The HUD provision of the regulation provides an incentive for the development of devices for use in the treatment or diagnosis of diseases affecting these populations.

Speaker: Elisa Harvey | View Anytime | Price: ¤132.00 | View Details

Using the Pre-Submission Process to Your Best Advantage

This webinar will provide a detailed discussion of understanding the scope of the pre-submission process, what information to provide in a pre-submission, how to prepare for a pre-submission interaction with FDA and how to follow up with FDA following a pre-submission interaction. To do this it will primarily reference the guidance document on pre-submissions recently finalized and issued by FDA earlier this year.

Speaker: Elisa Harvey | View Anytime | Price: ¤131.00 | View Details

Biocompatibility Testing of Medical Devices in the US and Use of ISO-10993

Biocompatibility testing is an essential and critical component of any US marketing application for a medical device that has direct or indirect contact with humans. This webinar will cover the FDA's existing and recently updated draft guidance on the use of ISO-10993 to determine what testing is necessary, and describe in detail general and specific testing considerations, based on the nature and duration of contact of the medical device with humans.

Speaker: Elisa Harvey | View Anytime | Price: ¤189.00 | View Details

Using the Pre-Submission Process to Your Best Advantage

This webinar will provide a detailed discussion of understanding the scope of the pre-submission process, what information to provide in a pre-submission, how to prepare for a pre-submission interaction with FDA and how to follow up with FDA following a pre-submission interaction. To do this it will primarily reference the guidance document on pre-submissions recently finalized and issued by FDA earlier this year.

Speaker: Elisa Harvey | View Anytime | Price: ¤189.00 | View Details

Understanding Combination Products, Requests for Designation and Product Jurisdiction

This webinar will provide a detailed discussion of understanding the definition of a combination product, the categories of combination products, how combination products are reviewed, how to assemble a request for designation (RFD) and how to work with FDA when submitting applications for combination products. To do this it will reference the extensive information provided by FDA’s Office of Combination Products.

Speaker: Elisa Harvey | View Anytime | Price: ¤189.00 | View Details