FDA to Device Industry: Teach Us More About Diagnostics and Sequencing


It might be hard to believe, but the US FDA, and the CDRH, doesn’t know everything.

Very often it all starts with a conversation with the people there. Lots of very helpful people there. I know. Is this an opportunity knocking?

The US Food and Drug Administration’s (FDA) medical device regulators are once again preparing to expand a program they use to learn about cutting-edge and essential medical technologies, this time with a particular focus on in vitro diagnostics and next generation sequencing (NGS) technology.


The program FDA has proposed to extend is known as the Experiential Learning Program (ELP), and was first proposed in September 2011 by FDA’s medical device regulatory body, the Center for Devices and Radiological Health (CDRH).

The ELP is meant to allow FDA’s regulators to learn more about the technologies they currently regulate and will likely regulate in the near future. The program, which was officially launched in April 2013, works by allowing FDA officials to attend “formal training visits” at industry sites. Companies choose to cooperate with FDA on a voluntary basis, FDA confirmed, and the visits are not intended to “inspect, assess, judge, or perform a regulatory function,” FDA said.

In a September 2011 statement announcing the launch of the program, CDRH Director Jeffery Shuren said the ELP would “help new medical device reviewers understand the challenges of technology development and the impact of medical devices on patient care.”

“We are investing resources so that new device reviewers at CDRH are equipped to handle the range of issues that arise during the premarket device reviews,” said Shuren. “This investment will improve the quality of submission review and make the process more consistent and predictable.”

To date, FDA has identified several dozen areas of interest, ranging from the manufacture of companion diagnostics to the operation of clinical testing in CLIA high-complexity laboratories.

An Expanding Focus

Since ELP’s launch in 2013, FDA has refined the number and types of topics it says it is interested in learning about.

For example, in August 2014, FDA said it would launch a “new component” of the ELP in the hopes of providing CDRH staff with “the policies, laboratory practices, and challenges faced in broader disciplines that impact the device development life cycle.” The new component is known as the “ELP General Training Program,” and is focused primarily on the premarket review process.

But the ELP has been refined in other ways as well. When the ELP launched in April 2013, it had 27 areas of interest, according to a Federal Register notice announcing the start of the program. One year later, FDA had refined that list down to 22 areas.

Now FDA is proposing a new, greatly expanded list of areas of interest for its ELP.

In a 8 April 2015 Federal Register notice, FDA said it had identified 34 areas of interest for its latest iteration of the ELP. Much of FDA’s new interest is related to in vitro diagnostics, a review by Regulatory Focus has found.

For example, in 2014 FDA said it was interested in learning more about eight topics related to in vitro diagnostics. In 2015, it selected a whopping 20 new topics of interest related to in vitro diagnostics and manufacturing technology.

To continue reading, please go to the Regulatory Affairs Professional Society, and this page.

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John Macey

I was born, and principally educated, in the fields of biochemistry, and business management in the northeastern USA. However, my world-wide professional career has greatly expanded upon that US base to involve the many different segments of the Biotech / Life Science fields globally. – I have been dressed as a surgeon to view many, many surgical proceedures - The major players in the health care fields that I have worked for include: Johnson & Johnson, DuPont, Abbott Laboratories, and F. Hoffmann-La Roche. – Positions have included selling nuclear materials for both in-vivo & in-vitro (radio-pharmaceutical & radio-immunoassay) medical diagnostic purposes, in the four countries in Scandinavia, based south of Stockholm, to managing Ph. Ds at a global Swiss headquarters location. – At one time I held a position of Strategy Manager for Europe, Middle-East & Africa (EME&A) for a Chicago based company, but living in Germany. – I do speak fluent colloquial German. – In addition to having lived in multiple European countries, my professional career took me to Asia for well over a decade. There I had management control of Oceania, the Pacific Rim, Northern Asia, Japan, out to India. – Occasionally, management assignments have taken me to all of Latin America, and most of South America. – I am extremely culturally aware, a skilled negotiator, and a seasoned manager of men and science. – My one abiding passion has always been computing, data, and analysis. As such, my main computer operating system is Linux, and open-source computer applications. – I do also run Microsoft 7, and Mac OS X (all 3 operating systems on the same H-P Ultrabook). I hope you enjoy your time on the Blog, and should you have any comments / feedback please feel free to email me @ jjmacey@jjmacey.net, or visit my Linux Web Site @ www.jjmacey.net (always evolving) – John J. Macey – AKA Adler, which in German means Eagle – Wildwood, New Jersey - Together, we can expand your global markets - with our partnerships. The partnerships are global utlizing multiple Law, Regulatory, Seasoned Management, Employment, M&A and buidlers of Business. Contact use.