Medical devices are categorized into classes based on the risk they pose to patients and users. This risk-based approach, used by regulators like the US FDA and in the EU, typically involves three or four tiers (e.g., Class I, IIa, IIb, III). Low-risk devices like tongue depressors are Class I, while high-risk, life-sustaining devices like pacemakers are Class III.
The risk-based classification system is a cornerstone of modern جهاز طبي regulation worldwide. It acknowledges that a one-size-fits-all regulatory approach is inefficient and potentially unsafe. Instead of subjecting every device to the most stringent review, regulators tailor their oversight to the potential for harm. The classification is determined by factors such as the device’s intended use, duration of contact with the body, degree of invasiveness, and whether it delivers energy or has a biological effect.
For example, in the United States, Class I devices (e.g., elastic bandages) are subject to ‘General Controls,’ which include registration and proper labeling. Class II devices (e.g., infusion pumps, powered wheelchairs) require ‘Special Controls’ in addition to general ones, often including performance المعايير and premarket notification (510(k)). The highest risk category, Class III (e.g., implantable pacemakers, heart valves), requires the most rigorous ‘Premarket Approval’ (PMA), which involves submitting extensive clinical data to prove safety and effectiveness.
This tiered system allows regulatory agencies to focus their resources on devices that pose the greatest risk, while facilitating market access for lower-risk innovations. The concept was foundational to the US Medical Device Amendments of 1976 and has been adopted and adapted by regulatory bodies globally, forming the basis for frameworks like the European Union’s Medical Device Regulation (MDR).
متاح للتحديات الجديدة
Mechanical Engineer, Project, Process Engineering or R&D Manager
متاح لتحدي جديد في غضون مهلة قصيرة.
تواصل معي على LinkedIn
Plastic metal electronics integration, Design-to-cost, GMP, Ergonomics, Medium to high-volume devices & consumables, Lean Manufacturing, Regulated industries, CE & FDA, CAD, Solidworks, Lean Sigma Black Belt, medical ISO 13485
احصل على جميع المقالات الجديدة
مجاني، لا يوجد بريد عشوائي، ولا يتم توزيع البريد الإلكتروني ولا إعادة بيعه
أو يمكنك الحصول على عضويتك الكاملة -مجانًا- للوصول إلى جميع المحتويات المحظورة >هنا<
(if date is unknown or not relevant, e.g. "fluid mechanics", a rounded estimation of its notable emergence is provided)
Related Invention, Innovation & Technical Principles
{{العنوان}}
{% إذا كان المقتطف %}{{ مقتطفات | truncatewords: 55 }}
{% endif %}
