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[FEATURED] Medtech Tips: 7 Expert Pointers For A Successful Pre-Market Submission To US FDA

FDAer-turned-consultant Heather Rosecrans offers valuable tips for a successful submission, from avoiding sending a PMA or 510(k) to the agency during the annual holiday season, to requesting a copy of an FDA reviewer’s work through a Freedom of Information Act request – and more.

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In this blog, we share our insights and experiences to help companies build quality, scalability, and flexibility into their regulatory writing.  We hope you find it insightful. For questions, please contact info@criterionedge.com.

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