Life Sciences

Device Congress: AdvaMed wants to calibrate Code with survey results

Device Regulation Alert: Safety, Compliance and Reimbursement News, April 2, 2007

A review group is working on enhancements to the AdvaMed Code. The organization hopes to calibrate the Code with results of device company surveys, such as one conducted this year by PricewaterhouseCoopers, King & Spaulding, and Compliance-Alliance. That's according to Christopher L. White, Esq., AdvaMed's general counsel, who spoke last week during the Second Annual Medical Device Regulatory, Reimbursement, and Compliance Congress in Cambridge, MA.

For example, the current Code doesn't have provisions that address off-label promotions or royalty arrangements, White said during the congress.

White also said that AdvaMed is receiving an increasing number of questions about more complicated topics.

"In the beginning, there were a lot of golf ball questions," White said, referring to questions about less complex compliance measures like gift giving. Now, companies are asking more about consulting arrangements, especially fair market value, and charitable contributions.

Stay tuned next week for more coverage from the Second Annual Medical Device Regulatory, Reimbursement, and Compliance Congress.

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