May 4, 2018

[FEATURED] Does EU Regulation Of 3D-Printed Implants Expose Gap In MDR Regime?

“Given that 3D printing is used for making device implants, many would expect tight regulation. But the EU Medical Device Regulation does not specifically regulate it, and there may be easier routes to compliance than companies think, according to attorney Joerg Schickert.”

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March 5, 2018

[FEATURED] EU Regulatory Reads, 2017: Are We Heading Toward A 2018 Crisis?

“Since the EU’s new Medical Device and IVD Regulations took effect in May 2017, progress toward implementation has been painfully slow. So, what is needed in 2018 to ensure the MDR and IVDR are viable?”

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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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December 11, 2017

[FEATURED] New 510(k) Modifications Guidance May Prompt New Submissions

US FDA has made at least nine changes releasing a final 510(k) modifications guidance on Oct. 24. This new guidance showcases useful flowcharts to help device sponsors determine when a new 510(k) submission will be needed for their product. The FDA states that “when evaluating a change in device and the need for a subsequent new 510(k) that requires an evaluation by agency staff, the agency ‘shall only require the “minimum required information” necessary to support a determination of substantial equivalence.’ “

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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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