Navigating Regulatory Challenges: A Conversation with Kapstone's VP of Regulatory
In the fast-changing world of medical device development, understanding the regulatory landscape is essential. Hayden Kapitan, Business Development Executive, dives into this important subject alongside Kara Johnson, VP of Regulatory. Their discussion highlights regulatory strategies and evaluations for industry professionals.
Hayden Kapitan: Kara, could you explain the distinction between a regulatory assessment and a regulatory strategy?
Kara Johnson: Certainly, Hayden. A regulatory assessment involves a preliminary review of a medical device to determine its regulatory requirements, focusing on relevant regulations and standards. A regulatory strategy, on the other hand, is a detailed plan that defines the pathway to obtaining regulatory approval or clearance, including timelines and resource planning.
Hayden: When should a development team start considering regulatory factors in the new product development (NPD) process?
Kara: It’s best to start at the concept phase (Phase I) of NPD projects. Integrating regulatory considerations early helps in identifying and navigating potential hurdles, ensuring compliance and facilitating smoother interactions with regulatory bodies.
Hayden: What’s the benefit of an FDA pre-submission?
Kara: An FDA pre-submission, or Q-submission, is useful for clarifying regulatory expectations and requirements for novel or complex devices. It allows companies to gain early feedback from the FDA to fine-tune their regulatory submissions.
Hayden: Can you distinguish between a pre-sub and a 513(g) submission? Are there differences in fees?
Kara: A pre-sub is a formal request for feedback on specific regulatory or testing aspects of your device, while a 513(g) submission seeks classification information from the FDA. The 513(g) helps determine the regulatory pathway, while a pre-sub addresses specific questions to ensure your approach meets FDA expectations.
Hayden: What’s the difference between the regulations (CFR numbers) and FDA CDRH product codes? Which indicates device class?
Kara: CFR numbers specify the regulations that devices must adhere to, such as design controls. FDA CDRH product codes categorize devices based on use and technology, helping to identify regulatory pathways and classifications. The product codes ultimately determine the device class.
Hayden: Considering the Medical Device Regulation (MDR) in the EU, should companies prioritize entering the US market?
Kara: The decision depends on the device, resources, and market needs. The US might offer a more straightforward pathway for some devices through the 510(k) process. However, the EU’s MDR has increased scrutiny and requirements, presenting challenges. Evaluating both the regulatory landscape and market potential is essential for strategic planning.
Hayden: What are common pitfalls in navigating regulatory pathways?
Kara: Companies often underestimate the time and resources needed for regulatory submissions and fail to address post-market requirements like adverse event reporting. Staying informed about regulatory changes and engaging experienced regulatory professionals can mitigate these challenges.
Hayden: Kara, thank you for your insights. It's evident that integrating regulatory strategies early in the development process is vital for success.
Kara: Absolutely, Hayden. A thorough understanding of regulatory nuances significantly enhances product success and market introduction.
This conversation underlines the importance of proactive and strategic regulatory planning in medical device development. By addressing regulatory requirements from the start and utilizing expert advice, companies can navigate the complex landscape effectively and bring innovative products to market successfully.