November 20, 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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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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January 9, 2018

2018 – Good For The Device Industry, Good For Patients, Good For FDA

Read through an interview with Maureen Mulvihill of Actuated Medical, Inc. as she shares her educated predictions on her outlook for the medical device industry in 2018. She talks about funding, innovations, and the FDA as dynamics change this year.

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October 12, 2017

Medical Device Single Audit Program: The Basics

Holding Globe in One Hand

Recently, the Regulatory Authority Council issued a report that the Medical Device Single Audit Program (MDSAP) has been successful in its pilot, and will therefore continue. So what is the MDSAP and why is it important? (more…)

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October 4, 2017

What the FDA Reauthorization Act Means for Pharmaceuticals and Medical Devices

Signing document

On August 18th, President Trump signed the FDA Reauthorization Act (FDARA). Besides reauthorizing user fees for pharmaceuticals and medical devices for five years the law also focuses on many aspects of device regulation. (more…)

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