2020 saw FDA taking an increasing look at digital health, particularly cybersecurity of smart devices.  Novel device approvals were also high.  Redica Systems GMP Medical Device Expert Mark Agostino addressed these and more in the second part of our interview with the latest Industry Expert to join our team.

Part I covered the EU Medical Device Regulation.

Combination Products Report

FDA launched the Digital Health Center of Excellence last September. Then, earlier this year, FDA announced its first acting head of cybersecurity for medical devices. Does this show that FDA is looking more closely at “smart devices?”

Medical devices are becoming increasingly connected to the internet, hospital networks, and other medical devices.  FDA recognizes this reality, which has led to the first acting Director of Cybersecurity for medical devices, Kevin Fu.  As medical devices become more connected, cybersecurity risks also increase.  The agency is working to be aggressive to keep up with a rapidly changing industry.

FDA does issue “safety communications” to medical device manufacturers in which vulnerabilities in the software have been identified.  Given the creation of the Director of Cybersecurity for medical devices, there will be a more focused oversight of connected medical devices to detect any vulnerabilities that could pose patient risk.

FDA also just announced that FY2020 proved a record year for novel device approvals despite the global pandemic. How can the industry keep this momentum going? What do you think spurred it?

The medical device industry is very dynamic.  Several of the approvals/clearances for new medical devices build upon existing platforms by identifying new intended uses and treatments for these technologies.  Medical device manufacturers are always innovating and developing new technologies to address an aging population in the United States.

As the pressures and strains caused by COVID-19 hopefully subside during 2021, the ability to complete clinical studies should become more predictable allowing for regulatory submissions to lead to new product introductions.

FDA is also expected to release more documents and information pertaining to combination products this year.  Which ones do you think medical device manufacturers will find the most useful?

The FDA released in December 2020 Requesting FDA Feedback on Combination Products. This is a useful guidance for sponsors of device-drug, drug-device, or biologic-device combination products. The guidance encourages interaction and involvement from the FDA during the development process to address questions and resolve open items to further ensure successful regulatory submissions.

Also, there is the draft guidance Bridging for Drug-Device and Biologic-Device Combination Products Guidance for Industry. This guidance provides a framework for bridging and leveraging related to a combination product that employs a different device constituent with the same drug constituent as the proposed combination product. This guidance also relates to a combination product that employs a different drug with the same device constituent as the proposed combination product.

About the Expert

Mark Agostino

Mark Agostino is Managing Director of QARA Biomed.  His areas of expertise include quality assurance and regulatory affairs for medical device and combination products.  He provides guidance to Sponsors and Contract Service Providers with meeting DHF and Technical File requirements, risk management, supplier quality processes, audits, preparing regulatory submissions, and ensuring compliance to global standards and regulations.

Combination Products Report

Get a Demo

We’ll can show you insights into any of your key suppliers, FDA investigators, inspection trends, and much more.

Request a Demo