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# Marking 40 Years of Medical Device Amendments
- URL: https://www.fdaweb.com/marking-40-years-of-medical-device-amendments/
- Published: 2016-06-22T12:00:00.000Z
- Updated: 2026-09-14T21:11:20.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136015

Writing in an *FDA Voice* blog [post](http://blogs.fda.gov/fdavoice/index.php/2016/06/fda-celebrates-the-40th-anniversary-of-the-medical-device-amendments/?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery), CDRH director **Jeffrey Shuren** says that in the 40 years since Congress passed the Medical Device Amendments, what started out as a mom-and-pop industry “has transformed into a world of sophisticated software, algorithms, miniaturization, combination products, wearable sensors, non-invasive procedures and diagnostics, robotics, and artificial intelligence.” And he says the Center has kept up by adapting its expertise and regulatory approaches to meet the needs of such rapidly evolving innovation.

Shuren says the CDRH staff has grown from 180 people to 1,700 individuals “with a wide range of scientific, clinical, engineering, legal, and other expertise, who hail from a variety of backgrounds, and who are ready to tackle the latest scientific advancement…. While we will continue to adapt, more importantly, we are focusing on proactively anticipating where we need to be so that regulatory innovation is out if front of medical device innovation. We’re doing this now in the digital health space, by designing regulatory frameworks around the type of technology and its unique evidence generation and innovation cycle rather than applying a one-size-fits-all approach.”

He discusses implementing new models for evidence generation, including establishing a National Evaluation System for health Technology (NEST) “that could transform the historical tension between device innovation, patient access, and patient safety into an alignment of interests to drive the development and more timely access to life-saving, life-enhancing, and life-advancing devices.”

And he describes efforts to establish a foundation to engage with patients as partners and routinely incorporate their perspectives in Center decisions.