Regulatory Strategy Development

Last Updated on 02/09/2024 by

Topic: Regulatory Strategy Development

Your Company Developed a New Blood Glucose Testing Medical Device and it is a Class II device. In developing your regulatory strategy, provide information on how you will address the following subheadings:
1.1.1 Regulatory Issues and Risks Related to Non-Clinical
Provide the current regulatory issues and risks for non-clinical, and propose preventive/contingency actions. Consider also future activities to be performed for non-clinical that are not (yet) issues, but that may become critical for the program in the future, if not addressed timely, e.g., timely initiation of two-year carcinogenicity studies to ensure availability of data for the registration dossier
1.1.2 Regulatory Issues and Risks Related to Clinical
Provide the current regulatory issues and risks for clinical, and propose preventive/contingency actions. Consider also future activities to be performed for clinical that are not (yet) issues, but that may become critical for the program in the future, if not addressed timely. Examples:
• the availability of sufficient clinical data in subjects of major markets that require a certain amount of clinical data in their own population for registration
• the adequate representation of geriatric patients in clinical programs for diseases predominantly prevalent in the very elderly
the strategy how to address critical findings related to safety (e.g., establishment of a safety advisory board overseeing the whole clinical program
1.1.3
Emerging Markets: Regulatory Risks and Issues Related to Country of Origin and Supply Chains
Provide the current regulatory issues and risks related to the chosen supply chain and country of origin, and propose preventive/contingency actions. Consider also future decisions to be performed for manufacturing that are not (yet) issues, but that may become critical for the program in the future, if not addressed timely. Examples:
• a non-ICH country is chosen for the main manufacturing steps
• country of origin is not the reference country for the main international countries (e.g., Eastern Europe in DCP/ MRP procedures)
• only FDA approval available, and the main manufacturing site is not in the US

1.1.4 Other Regulatory Issues and Risks
Provide other known regulatory issues and risks, e.g., the quality of data likely not meeting the expectations of health authorities (or an individual authority) regarding format and/or content. Propose preventive/contingency actions. Consider also future activities that are not (yet) issues, but that may become critical for the program in the future, if not addressed timely, e.g., the timely application for trademark / trade name to have it available at the time of MA application, or, in case of a medical device development, the timely CE mark or 510K application, the conduct of “clinical” trials such as a human factor study, usability study, label comprehension study, or usability test.
1.1.5 Regulatory Risks Related to Timing
Describe any risks related to the timing of submissions

Note:
You may Reference Medical Device Regulations from ICH, Canada, European Union and USA if need be.
Use APA Style (In-text and Reference Citations)
Be Creative!!
Length: 6 pages