What is Regulatory Due Diligence for Medical Devices?

What is regulatory due diligence? Why does it matter, and how does it differ from other regulatory strategies and pathways? 

In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues of Vascular Sciences about the importance of and reasons for regulatory due diligence that all medical device professionals should know.

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Some highlights of this episode include:

• Regulatory due diligence involves looking at what’s been done so far when a company is developing a medical device similar to one on the market already.
• Due diligence is important for business, regulatory, and engineering/product development perspectives to know before investing time, effort, and resources.
• Differences and Similarities: Regulatory due diligence, regulatory strategy, and regulatory pathway to market are not synonymous and may depend on another. 
• Regulatory due diligence can be applicable to new or existing medical devices. Due diligence from an existing device provides essential background information.
• Reminders/Requirements: Update regulatory due diligence in quality management system (QMS) and risk management plan through product lifecycle. 
• Past, Present, Future Challenges: Evolve and emphasize changes/corrections for prevention, design, risk, manufacturing, and regulatory perspectives.
• Decouple and Rebuild: FDA is inherently concerned about entirely new and/or novel medical devices and technologies. 
• Take a cross-functional team approach to understand different perspectives, roles, and tasks to produce improved quality and regulatory due diligence.

Links:

Premarket Notification 510(k)

De Novo

Premarket Approval (PMA)

Humanitarian Device Exemption (HDE)

FDA: Medical Device Guidance Documents

Mike Drues

Vascular Sciences

MedTech True Quality Stories Podcast

Greenlight Guru YouTube Channel

Greenlight Guru

Memorable Quotes from this episode:

“Due diligence is knowing the state of affairs...from a regulatory perspective, before I dive too deep and invest too much time, money, effort, and resources.” Jon Speer

“Regulatory due diligence...is important for any medical device-whether it’s an existing device that’s similar to something already...or a new or novel device.” Mike Drues

“As a med device company, I have an obligation to make sure that the information about my product is...up to date and current.” Jon Speer

“As an industry, we tend to focus on the past, rather than the future...that’s kind of problematic.” Mike Drues

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