FDA is Using the Least Burdensome Approach. Are You?
End the Endless Cycle & Increase Business Growth
Achieving and sustaining Regulatory Compliance is a huge resource drain for Medical Device companies. That is why it is refreshing to hear that the FDA is now renewing its focus on a least burdensome approach to all regulatory activities.
This change in mindset offers an opportunity to review current policies and practices affecting compliance related activities. Truth is that most organizations focus on Documentation and not necessarily on improving product safety and effectiveness through Compliance. More documents are created in the name of Compliance, which need to be checked and re-checked during audits. When issues are found, additional documents are created through remediation activities and procedural updates. So, the cycle continues without an end in sight.
No wonder Compliance is seen as a burden and not as an enabler of innovation and business growth. The least burdensome approach is a way to now change this perception.
Least burdensome is the minimum amount of information necessary to adequately address a regulatory question or issue through the most efficient manner at the right time.
It does not mean that we need to lower our expectations or relax the rules. What it means is that we become mindful and efficient in our Compliance activities.
FDA has taken the least burdensome approach across the entire product lifecycle, not just during the pre-market review as required by the 2016 Cures Act. Risk-based compliance policies are now acceptable within the new framework. In the newly issued draft guidance, FDA has highlighted its enforcement discretion policy for certain low risk devices and devices considered a medical necessity. Additional discretionary policies are likely to be announced in future.
The application of the goals of the least burdensome approach has resulted in new efforts to implement risk-based compliance policies (by the FDA)
A similar risk-based approach to your internal Compliance policy can help you refocus your resources on the most value-added activities.
Effective Compliance is achieved by the right balance of the What and the How. Too much of either usually results in burdensome requirements and inconsistent practice across the organization. It is important to remember that no one intentionally tries to be out of Compliance. If the procedures and work instructions are not designed optimally, people figure out a better, more effective, way of doing their jobs. What may be seen as non-compliant on the surface is simply a symptom of underlying issues in the Quality System.
A risk-based approach can help drive both efficiency and effectiveness in the system by focusing resources and attention on the most critical areas. Again, it does not mean that requirements for other areas are relaxed or ignored. Rather, the balance of the What and the How for each area can be adjusted based on risk to overall safety and effectiveness. Removing redundancies and conflicting requirements is another way to improve efficiency.
Use data from product and process surveillance to monitor and update risks
Continuous monitoring and assessment of risks is key to effectively implementing the least burdensome approach. Risk-management, therefore, needs to become a core competence of the entire organization, including Quality and Regulatory Compliance. Typically, organizations rely on subject matter expertise for risk assessment. However, these resources are limited, scattered across different departments and not always readily available for ongoing risk monitoring. Fortunately, new tools for automating data collection and analytics are now available that can help develop this capability.
In conclusion, there is now an opportunity to transform your Regulatory Compliance program and change the perception that it is not a burden but an enabler. Taking a risk-based approach is key to achieving success!
Least Burdensome Provisions: Concepts and Principles (Draft), Dec 2017
New Steps to Facilitate Beneficial Medical Device Innovation, Dec 2017