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Greetings! First post here, so please be gentle with me. I have a question that I hope someone out there can answer. I've struck out with all my colleagues in the QA world and my lawyer friends, and I have found nothing pertinent on the FDA website. All my years in QA, and this is the first time someone has put this question to me - and of course, it's the person I'm contracting for.
Let’s say a medical device manufacturer is thinking of doing a beta program with external organizations. The device is a small measurement tool that plugs into a PACS. There is no 510(k) in place yet, so the product can’t be sold. Can the manufacturer charge the beta site anything and not run afoul of FDA regulations? Specifically, can it be reimbursed for travel expenses and/or consulting time? Not being reimbursed for these things makes field validation and feedback rather... cost-prohibitive. Any guidance would be most appreciated.
If there is a link to any actual rule on this, I would appreciate that as well.
Let’s say a medical device manufacturer is thinking of doing a beta program with external organizations. The device is a small measurement tool that plugs into a PACS. There is no 510(k) in place yet, so the product can’t be sold. Can the manufacturer charge the beta site anything and not run afoul of FDA regulations? Specifically, can it be reimbursed for travel expenses and/or consulting time? Not being reimbursed for these things makes field validation and feedback rather... cost-prohibitive. Any guidance would be most appreciated.
If there is a link to any actual rule on this, I would appreciate that as well.