The Key Steps to Identify A Regulatory Requirements Strategy
When developing medical devices it is important to understand the regulatory landscape that is applicable to your particular device and to jump start the approval process with the appropriate regulatory agency/agencies.
It is important early in the development process to get involved with the relevant regulatory agency and to understand the associated regulatory requirements: laws, guidance documents, and international standards.
Developing medical device regulatory strategy involves a number of key steps. All these steps are intertwined with regulatory compliance considerations, hence the necessary involvement with various agencies from the beginning.
The first step is classifying the medical device by identifying the indication(s) for use of the medical device. This identification leads to the device classification and the respective regulatory oversight requirements. Indication(s) for use describes the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the target patient population. Additionally, the FDA’s Guidance for Industry General/ Specific Intended Use should be consulted.
FDA classifies medical devices based on the risks associated with the device. Devices are classified into one of three categories—Class I Class II, or Class III. Class I devices are deemed to be low risk, Class II devices are higher risk devices than Class I and require greater regulatory controls to provide reasonable assurance of the device’s safety and effectiveness. Class III devices are generally the highest risk devices and are therefore subject to the highest level of regulatory control. Class III devices must typically be approved by FDA before they are marketed.
Once the medical device has a classification, a written regulatory strategy should be established that identifies the specific regulatory requirements as well as possible pathway(s) to take. Additionally the product development plan should be written. These two documents are constantly evolving documents that need to be reviewed and updated on a regular basis during the product development process. Therefore, the early involvement with the relevant regulatory agencies is paramount.
To verify that the regulatory approach is acceptable, an important step is to schedule a pre-submission meeting with the FDA who will review the proposed regulatory strategy and provide key feedback and give guidance on any critical issues that arise.
Early and effective communication with the appropriate regulatory agency is essential to achieve a complete and robust submission that meets the agency’s expectation and streamlines the review process. It is vital to establish communication with an agency during critical stages of product development to exchange ideas and assist with development planning, address potential critical issues, and bring clarity to the agency’s expectations on submission requirements. Through early and open communication, informal or formal (such as pre-submission meetings), regulatory agencies may help by:
•Clarifying the regulatory pathway for product development
•Identifying and interpreting relevant regulations, directives, guidance documents and recognized standards applicable and specific to your particular product
•Providing scientific and regulatory advice during product development resulting in a more robust product development plan
•Providing advice regarding the study design that may affect the regulatory decision about submission approval
•Discussing any deficiencies that may occur at critical points of product development or required clinical trials
Effective involvement with regulatory agencies early during product development is key to regulatory strategy and success.