Regulatory

Legislation Streamlines FDA Approval Process for Medical Device Industry

BY MAURY THOMPSON, THE POST-STAR, GLENS FALLS, N.Y. / DECEMBER 28, 2016

(TNS) — The federal Food and Drug Administration has required medical companies testing new products to get permission from multiple separate regional FDA review boards across the country wherever test subjects live.

Legislation that President Barack Obama signed earlier this month will allow medical device companies the option of reporting to one centralized FDA review board, saving the companies time and expenses involved with the previous duplicative process.

“Particularly for many of our start-up or smaller companies, a provision like that is really a beautiful regulatory efficiency proposal that doesn’t do anything to change the importance or the soundness of the clinical trial,” said JC Scott, chief advocacy officer for AdvaMed, a medical device industry trade organization.

The provision is an example of myriad regulatory reforms of significance to the medical device industry in the 21st Century Cures Act, which Obama signed Dec. 13.

The comprehensive legislation streamlines the regulatory process for pharmaceutical and medical device companies, sets medical research policy, and provides federal funding for medical research, including $1.8 billion in new funding for cancer research.

“This critical legislation invests more in science and research, removes barriers that stand in the way of modern treatments, and advances personal medicine to ensure that patients can be treated based on their unique characteristics,” said U.S. Rep. Elise Stefanik, R-Willsboro, in a news release.

 

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Josh Sandberg

Josh Sandberg is the President of Ortho Sales Partners and Partner for The De Angelis Group. He also serves as Co-Founder and Editor of OrthoSpineNews.

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