October 31, 2019

[FEATURED] It’s Raining Guidance Docs: FDA Expands Abbreviated 510(k) Program

In a new final guidance, the US agency has expanded its abbreviated 510(k) program for certain devices to look beyond conformity assessments and instead look at performance criteria. Alongside the guidance, the agency also released four draft guidances for devices it is considering clearing under the new pathway.

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August 28, 2018

[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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