US regulatory plan
Outline of the process from identification of medical unmet needs to post-market monitorization, emphasizing preclinical evaluation, risk-based classification, FDA engagement through Q-Submissions, and possible regulatory pathways (e g 510(k), HDE, PMA, and De Novo)
Main categorization based on risk (class I, II or III), determination of the level of regulatory control and submission requirements, from exemptions to 510(k) notifications and full PMA approvals
US Medical Device Classification US FDA Regulatory Pathway
US FDA Regulatory Pathway - definition of approval processes based on device risk (including general controls for Class I, 510(k) for Class II, PMA for Class III, and alternative routes like De Novo and HDE) to ensure device's safety and effectiveness before market entry.
Quality Management System (QMS)
Review of FDA requirements for registering medical device facilities and listing products via FDA Unified Registration and Listing Systems (FURLS). Includes annual registration fees, timelines, and obligations for domestic and foreign manufacturers, including maintaining updated records and preparing for FDA audits
US Import Requirements
Overview of how to manage product changes under QMS, assessing their impact on regulatory filings Outlines when to submit a new 510(k) based on changes impacting form, fit, function, labeling, software, firmware, assembly process, or product testing (or its components) Distinction of Traditional, Abbreviated, and Special 510(k) types to file
US PostMarket Safety Monitoring
Overview of QMS requirements under 21 CFR 820 and ISO 13485, focusing on streamlined procedures for design, manufacturing, supplier management, risk management, complaint handling, clinical data, storage, distribution, and product labeling
US Registration and Listing
Overview of the essential steps for foreign manufacturers to import medical devices into the US, including appointing a US Agent and accurate labeling per 21 CFR 801
Change Assessment
Summarization of FDA post-market requirements, including complaint handling, adverse event reporting (21 CFR 803), and product corrections or removals (21 CFR 806) Highlights reporting to FDA using key tools used to track, address, and communicate issues related to medical device safety and compliance
provided as an overview
Overview of regulations that classifiy IVD as part of FDA risk based approach. How classifications are defined based on risk and intended use of the final product. How each classification ties into the premark review process is included
Premarket Review and Approval Pathways
Reference to the FDA labeling regulations and listing of required content for product labeling including instructions for use, performance and interpretation of results
FDA IVD classifications
Included is an overview of controls for Class I IVDs that do not require prior review or approval for FDA. Details on the Pre market Notification for Class II and Premarket Approval for Class III products will also be covered Finally, an overview of the Investigational Device Exemption for products requiring clinical data will be discussed
IVD Labeling Requirements
FDA guidance on IVDs and Resources
Listing of applicable FDA regulations for IVDs and links to available FDA resources including FAQs and other information that may be helpful to manufacturers