Strategic Support for Medical Device Regulatory Challenges
Resources
Comprehensive Regulatory Assistance (Device Advice)
http://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance
A valuable resource for understanding the regulatory requirements for medical devices. This page provides guidance on all stages of device development, including classification, premarket submissions, labeling requirements, and postmarket activities. Ideal for both new and established manufacturers seeking a clear path to regulatory compliance.
Overview of Medical Device Regulations
http://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation
This FDA page offers a comprehensive overview of medical device regulations, from classification to postmarket obligations. It’s a go-to resource for understanding how devices are regulated in the U.S. and what’s needed for compliance at each stage of development and marketing.
Premarket Notification 510(k) Submissions
http://www.fda.gov/medical-devices/premarket-submissions/premarket-notification-510k
Provides detailed information on the 510(k) process, including when it’s needed, how to prepare a submission, and the specific requirements involved. This is essential for developers of Class I and Class II devices who need FDA clearance to bring their products to market.
Quality System (QS) Regulation/Medical Device Good Manufacturing Practices
http://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices
This resource details the Quality System Regulation (21 CFR Part 820), which outlines the cGMP requirements that medical device manufacturers must follow. It’s crucial for ensuring that devices meet safety and performance standards.
FDA Small Business Assistance for Medical Devices
http://www.fda.gov/medical-devices/industry-medical-devices/small-business-assistance-medical-devices
Tailored specifically for small businesses, this page offers tools, webinars, and guidance to help navigate regulatory requirements. It also includes information on how to qualify for fee reductions and other benefits available to small device manufacturers.