Glossary Term
Regulatory Pathway
Definition
A regulatory pathway refers to the specific set of steps, processes, and requirements that a medical device, pharmaceutical product, or healthcare solution must go through to gain approval from regulatory bodies, such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), or other national or international regulatory agencies. The pathway includes submitting necessary documentation, conducting clinical trials, demonstrating compliance with safety and efficacy standards, and meeting any additional requirements specific to the type of product being developed. The regulatory pathway ensures that products are safe, effective, and suitable for their intended use before they can be marketed to the public.
Relevance to the MedTech Industry
Regulatory pathways ensure that new medical products, devices, and therapies meet the necessary safety, efficacy, and quality standards to protect public health. By following a defined regulatory pathway, companies can navigate the approval process, demonstrate compliance with regulatory requirements, and bring their products to market while minimizing risks to patients and healthcare systems.
Additional Information & Related Terms
Related Terms
Premarket Approval (PMA): A regulatory pathway for high-risk medical devices that require rigorous clinical testing and evidence of safety and efficacy before approval.
Fast-Track Designation: A process by which the FDA expedites the review and approval of drugs or devices that address unmet medical needs.
Clinical Trial Design: The framework and methodologies used in planning and conducting clinical trials, which align with the regulatory requirements of the product’s intended market.
Regulatory Affairs: The field responsible for ensuring that a company’s products comply with all regulations and standards set by health authorities like the FDA and EMA.