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Treat FDA as Your Customer

There are numerous details that OEMs must consider when seeking market clearance. One significant principle that is often forgotten is that FDA should be treated as a customer.

This was the advice of Michael Barile of Barile & Associates in his talk, "Anticipating and Avoiding Regulatory and Compliance Hurdles," at the conference session, "Manufacturing for Innovation," at MD&M West. Barile stressed the importance of approaching premarket approvals or 510(k)s by anticipating the reviewers needs and identifying with their point of view.  He also reiterated the need to use checklists and cover sheets provided by FDA. The most important thing, he said, is to organize the information and make it as easy to understand. FDA rewards organization and it is critical to jumping hurdles to gain market access. "FDA may not be paying you for your product like a regular customer," he said. "But you need them to become part of the market."

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