RAC (Devices) Prep Toolbox with Fundamentals of Medical Device Regulations (Print)
The RAC-Devices bundle includes:
Device Curated e-learning content
Section 1: Getting Started
Section 10: Knowledge Check
- RAC Prep Toolbox Overview
- Planning for the Exam
- Digital Flashcards
- Introduction to Domain I
- EU Regulations for Medical Devices
- Obtaining the CE Mark
- Regulatory Framework in the EU
- Determining a Device Classification
- Classification of Medical Devices
- Classification of IVDs
- Conformity Assessment Options for Medical Devices
- Conformity Assessment Options for IVDs
- Other Related Legislation
- Introduction to Domain II
- Annex I: General Safety and Performance Requirements
- MDR/IVDR Chapter I: General Requirements
- Chapter II: Requirements regarding device design and manufacture (MDR)
- Chapter III: Requirements Regarding the Information Supplied with the Device (MDR)
- Chapter II: Requirements Regarding Performance, Design and Manufacture (IVDR)
- IVDR Annex I: Chapter III
- Annexes II and III: Technical Documentation (EU MDR/IVDR)
- Annex IV: EU Declaration of Conformity (DoC)
- MDR Annex XIV: Clinical Evaluation and Postmarket Clinical Follow-up
- IVDR Annex XIII: Performance Evaluation, Performance Studies and Postmarket Performance Follow-up
- MDR Annex XV: Clinical Investigations
- MDR Annex XIII: Procedure for Custom-Made Devices
- MDR Annex XVI: List of Groups of Products Without an Intended Medical Purpose (Article 1(2))
- MDR/IVDR Annex IX: Conformity Assessment Based on a QMS & Assessment of Technical Documentation
- MDR/IVDR Annex X: Conformity Assessment Based on Type-Examination
- MDR Annex XI: Conformity Assessment Based on Product Conformity Verification
- IVDR Annex XI: Conformity Assessment Based on Production QUALITY Assurance
- ISO (EN ISO 14155)
- ISO 20916
- Other Standards
- Introduction to Domain III
- Postmarket Requirements of Manufacturers and its Economic Operators (EOs)
- Postmarket Requirements of Person Responsible for Regulatory Compliance (PRRC)
- Postmarket Surveillance
- Corrective and Preventive Action
- Postmarket Studies
- Medical Devices Vigilance System
- Market Surveillance
- Standards and Guidance Documents
- Introduction to Domain IV
- General Guidance
- Notified Body Designation and Oversight
- Notified Body Application Process
- Manufacturer Competent Authority Interaction Prior to Placing Devices on the Market
- Technical Documentation and Conformity Assessment Procedures
- Vigilance Reporting and Communications/Interactions with Competent Authorities and Notified Body
- Post-Market Surveillance Process
- Changes to Devices and Quality Management Systems for Medical Devices/IVDs
- Clinical/Performance Evaluation Interfacing
- Clinical Investigations (MDR)/Performance Studies (IVDR)
- Device Qualification and Classification
- Competent Authority Market Surveillance Activities
- Administrative Provisions
- Introduction to Domain I
- Medical Device Regulation for Strategic Planning
- Determining the proposed product classification
- Classification
- Strategic Planning for Submission
- FDA Centers for Submissions and Interactions
- Device Classification and Regulatory Controls
- Medical Device Amendments 1976
- Safe Medical Device Act (SMDA) 1990
- Food and Drug Administration Modernization Act (FDAMA) 1997
- Medical Device User Fee and Modernization Act (MDUFMA) 2002
- Food and Drug Administration Amendments Act (FDAAA) 2007
- Food and Drug Administration Safety and Innovation Act (FDASIA) 2012
- 21st Century Cures Act of 2016
- Food and Drug Administration Reauthorization Act (FDARA) 2017
- What Device Manufacturers Must Know
- Relevant CDRH Offices
- Finished Devices
- Accessories and Components
- Predicate Device
- Substantial Equivalence
- In Vitro Diagnostics
- Clinical Chemistry and Clinical Toxicology Devices
- Hematology and Pathology Devices
- Immunology and Microbiology Devices
- IVD Classification Introduction
- Class I IVDs
- Class II IVDs
- Class III IVDs
- Combination Products and Primary Mode of Action
- Definition of “Mode of Action”
- The FDA’s Definition
- 21 CFR 3.2(e)
- The Essential Steps to Getting a Device to Market
- Is the product a medical device?
- What is the device classification?
- Class I
- Class II
- Class III
- Product Codes
- 510(k) Exempt
- Exemptions from 510(k)s
- So Many Types of Submissions, So Little Time
- Premarket Notification 510(k)
- Substantial Equivalence
- Introduction to Domain II
- Types of Premarket Submissions
- Traditional 510(k)
- Alternative Approaches
- Special 510(k)
- Abbreviated 510(k)
- Content and Format of a 510(k)
- Premarket Notification
- Guidance Documents
- 510(k) Submission
- Documentation Expectations
- Smartscope Submission
- Clinical Studies
- Globally Harmonized Format
- eSubmissions
- IVD Submission Requirements and Review Process
- Timing
- IVD Content and Format
- Limitations
- 510(k) Review Process
- 510(k) Third Party Review Program
- FDA Action on a 510(k)
- De Novo: First-of-a-Kind Device Low-to Medium-Risk Devices
- De Novo Classification Process Overview
- Changes to the De Novo Process
- Format and Content
- Class III Devices
- Introduction to PMA Application
- A PMA Must Contain
- PMA Submissions Require Clinical Data
- Demographic Subgroup Participation
- Manufacturing Facility Inspection
- Preamendment Devices
- Standalone Proof of Safety and Effectiveness
- Submit Required Sections
- Advisory Committee Recommendations
- Content and Format of a PMA -Information Required in a PMA
- Third-Party Supplier & eCopy
- Update a Pending PMA
- Device-Specific Guidance
- Class III IVDs
- PMA for IVDs
- BLA for IVDs
- Introduction to Electronic Submissions
- Creating the eCopy Files
- Requirements
- Human Clinical Investigations Conducted Outside the US
- Modular PMA Approach
- Product Development Protocol
- PMA Document Control Number
- Four Steps of the Review Process
- Regulatory Commitment
- FDA Action on a PMA Before the Filing Review
- After the Initial Filing Review
- Once the PMA is Filed
- Approval Order
- Approvable Letter
- Not Approvable Letter
- Denial of Approval Letter
- PMA Amendments and Supplements
- Changes Requiring a PMA Supplement
- PMA Resources
- Standards and Conformity Assessment Program
- Humanitarian Device Exemption
- Introduction to Domain III
- Labeling, Advertising & Promotion
- Authority to Regulate
- Label
- Labeling
- Device Categories
- Part 801--Labeling
- Prescription Devices
- Medical Devices Having Commonly Known Directions
- In Vitro Diagnostic Products
- Labeling Requirements: In Vitro Diagnostic Devices (IVDs)
- Labeling Requirements: Restricted Medical Devices
- Promotional Labeling
- Medical Device Advertising
- Failure to Disclose
- Strict Liability Statute
- Restricted Devices
- Reminder Piece
- Direct-to-Consumer
- Consumer-Directed Broadcast Advertising of Restricted Devices
- Product Regulation by FTC
- Disease-Awareness Communications
- Reminder Labeling
- Investigational Devices
- Regulation of CME Promotion
- Postmarket Surveillance
- Postapproval Studies by PMA Order
- Postapproval Requirements
- Types of PMA Supplements
- Special PMA Supplement: Changes Being Effected [§814.39(d)(1)]
- 30-Day Notice and 135-Day PMA Supplement-§814.39(f)
- Annual (Periodic) Report or 30-day Supplements-§814.39(e)
- Device Modifications
- Medical Device Reporting
- User Facility Reporting Requirements
- Importer Reporting Requirements
- Manufacturer Reporting Requirements
- MAUDE Data
- Required to Submit and Recall Process
- Classification of Recalls
- Violation of the Laws
- Regulatory Responsibility
- Misclassifying a Recall
- Unique Device Identification
- Labeler: Responsibility and Definition
- UDI Components
- UDI Compliance
- FDA Export Requirements
- Ordering Export Certificates & Permits
- FDA Import Requirements for Medical Devices
- Radiation Emitting Electronic Devices
- Quality System
- Medical Device Tracking, 21 CFR 821
- Introduction to Domain IV
- FDA Meetings for Regulatory Submissions
- Informal Meetings with FDA
- CDRH Management Directory
- OPEQ Divisions
- OHT Organizations & OIR Divisions
Section 10: Knowledge Check
- Practice Test
Neither RAPS nor the RAC Program states or implies that preparation material provided by RAPS is the best or only means of adequately preparing for the RAC examination. No advantage is given to candidates who purchase or use RAC preparation material provided by RAPS over candidates who prepare using other materials and/or methods. The use and purchase of preparation courses and materials from RAPS is optional.
