MCRA RESOURCE CENTER
REGULATORY MCRA works with a wide range of clients on various FDA pathways necessary to acquire 510(k) clearance or IDE and PMA approval. MCRA assists clients developing novel joint replacement technologies to state of the art trauma and fixation devices.
GENERAL ORTHOPEDIC
510(k) • An Overview of the 510(k) Marketing Approval Process; Including:
a) What is a 510(k) b) When is a 510(k) Required c) Who is Required to Submit a 510(k) • How to Prepare a Traditional 510(k) • Deciding if a New 510(k) is Needed for a Modification to an Existing Approved Device • How to prepare a Special 510(k) – Modification of an existing device
• Deciding When to Submit a 510(k) for a Change to an Existing Device • Device Advice: Premarket Notification 510(k)
IDE/PMA
• FDA Pre-Market Approval (PMA) Database
Other Regulatory Links of Interest • FDA Center for Devices and Radiological Health • FDA Center for Devices and Radiological Health Database Search • Humanitarian Device Exemption (HDE) Regulation: Questions and Answers • Device Advice: Institutional Review Boards • Guidance Document: Clinical Data Presentations for Orthopedic Device Applications - Guidance for Industry and FDA Staff • Guidance for Industry and FDA: FY 2007 MDUFMA Small Business Qualification Worksheet and Certification
Large Bone & Joint Submissions
• Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis; Guidance for Industry and FDA • Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA • Guidance Document for the Preparation of IDE and PMA Applications for Intra-Articular Prothetic Knee Ligament Devices • Guidance Document For The Preparation of Premarket NotificationFor Ceramic Ball Hip Systems • Reviewers Guidance Checklist for Orthopedic External Fixation Devices
Small Bone & Joint Submissions • The Small Bone and Joint U.S. Regulatory Landscape • Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis
Other Orthopedic Products • Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement; Guidance for Industry and FDA • Guidance Document for Testing Biodegradable Polymer Implant Devices
• Guidance Document For Testing Bone Anchor Devices • Guidance Document for Testing Non-Articulating, 'Mechanically Locked', Modular Implant Components
• Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone Or Bone Cement • Reviewers Guidance Checklist for Intramedullary Rods
