Sampling of survey feedback from the initial broadcast on October 22, 2019:

"Thanks for answering the question I submitted regarding colorant change as a design change for medical devices. Thank you so much for these webinars. They really help us stay compliant with so many regulatory changes."

"I really enjoy your presentations- they are informative and relevant. The information you impart is tangible, unlike so many others who speak at such a high level and are not willing to actually listen to the context of a question- you guys try to answer and really get to the heart of an issue. Thank you for offering these- very much appreciate the education!"

"This was a great webinar as always. I really appreciate the fact they are free and the content is shared with viewers after the fact."

"Great webinar. Fantastic speakers. Valuable information."

"My training/background is in R&D but i feel it is necessary nowadays to be informed about what comes after basic research. So I like to listen in on your webinars to broaden my horizon. As research scientists we are lacking some of the regulatory insight and I am always glad to get some 'pointers'."

"Very informative and very well-presented webinar."

"Both speakers were very knowledgeable and outstanding in their time commitment."

""This was my first attendance at one of your seminars and I was impressed at the content, the presentation skills and the usefulness of the information shared.

I appreciated the real world examples that were provided that framed the applicability of the concepts being discussed.

I also appreciated the perspectives provided by Jake in terms of the challenges that the Agency may have in implementation. This provides breadth to understanding implications."

"R&Q team is very knowledgeable o these subjects and webinars showcases their competencies!"



This webinar will highlight key areas of change related to the FDA and actions medical device manufacturers might consider taking in response to these updates.

We’ll cover the following topics:

1. FDA’s Breakthrough Devices Program, an outcome of the Cures Act and the 2017 Reauthorization Act, became final in December 2018. Because the information is considered confidential, the public information on devices that have been granted that status is limited but FDA has said that over 100 devices have been granted breakthrough status. We will share our experience with the program and how it impacts FDA interactions.

2. Medical Device Development Tools (MDDT)— Do you have an awesome evaluation tool that you think negates the need for clinical studies on your device? We will take a look at the little utilized MDDT option to qualify your tool or utilize another person’s tool to demonstrate device performance outside of a clinical trial. There have been four tools identified thus far and we’ll describe how you could potentially use them to reduce trial needs, shorten time frames, and more.

3. FDA’s Efforts to Harmonize and Modernize the Quality System Regulation— FDA has announced their intentions to adopt ISO 13485:2016 as the de facto GMP requirements set in lieu of the Quality System Regulation (21 CFR 820). Our former FDA Investigator Jake O’Donnell will discuss the process by which regulations are changed, and his view of the probable impact of the switch to ISO 13485:2016 on medical device manufacturers.

4. FDA Restructuring Process— The FDA Medical Device and Radiological Health community has also been changing organizationally, starting with Program Alignment several years ago, and continuing with the reorganization of CDRH to a structure perceived as more conducive to full life-cycle management of medical devices. Jake O’Donnell will discuss these changes and his views on how they may affect regulated industry.

5. Safety and Performance Based 510(k)— we will address how submissions have been ‘revamped’ with the expansion of an abbreviated pathway called the Safety and Performance Pathway. For devices that qualify (based on indication, technological characteristics, and safety and performance criteria) this pathway will be an option to allow manufacturers to demonstrate that their device is substantially equivalent to a predicate device in a way that is less burdensome, but as least as robust as a traditional 510(k). The safety and performance pathway holds promise to streamline the FDA 510k device process when the device is well established and standards and guidance are available. This feels like another step towards harmonization with the usage of standards instead of requiring side by side testing with the predicate device.



Nancy Morrison – Executive Director, Regulatory & Quality Consulting Services
Regulatory & Quality Solutions (R&Q)

Morrison_Square-minNancy has over 25 years of quality and regulatory experience in the medical industry with US and global regulatory submission experience. The previous five years have been with R&Q working with start-up, mid-size and multi-national medical device and combination product companies. Nancy has a Bachelor of Science in Mathematics and an Advanced Certificate in Regulatory Affairs along with RAC certifications for the US and EU. Nancy has the ability to build collaborative relationships with stakeholders to utilize regulations to identify opportunities that provide compliant and effective business solutions.


Jake O'Donnell – Senior FDA Compliance Principal (former FDA)
Regulatory & Quality Solutions (R&Q)

jake_square-min-1Jake O’Donnell’s 30+ year career includes 20+ years as a device investigator for FDA, 12 years as an aerospace engineer / program manager as a civilian employee of the Naval Air Warfare Center, and most recently, service with R&Q as Senior FDA Compliance Principal. Jake holds certifications as an ASQ Certified Biomedical Auditor and BSI ISO13485:2016 Lead Auditor (TPECS). His formative professional years as a civilian employee of the U.S. Navy included advanced technology development activities, system and component level test and evaluation, and fleet support activities – providing an understanding of the challenges of commercializing complex systems. Jake brought system development and design assurance experience with him to FDA in the mid-90s when FDA was rolling out the then new Design Control regulation, which served both the agency and Jake well in his new role. Jake has conducted about 400 FDA inspections of all types of medical device manufacturers, both domestically and internationally.

Since arriving at R&Q Jake has helped numerous clients with QMS gap assessments, FDA preparedness training and assessments, and support of remediation activities for clients ranging from small start-ups to global concerns.  Career highlights include contributions to the Navy’s RPV program (SCUD hunters), selection to FDA’s dedicated cadre of device investigators for international inspections reporting directly to HQ, and developing a reputation as a tough but fair investigator regionally and nationally.