Medical Device Guidance Documents Issued During FY2010 through September 30, 2010 (MDUFMA FDA Performance Report October 27, 2010)

Fourth Quarter (July 2010 – September 2010)

• Guidance for Industry and FDA Staff - Addition of URLs to Electronic Product Labeling
• Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters
• Guidance for the Non Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH)
• Guidance for Industry and Food and Drug Administration Staff - Contact Lens Care Products Labeling
• Guidance for Industry and FDA Staff: General Considerations for Animal Studies for Cardiovascular Devices
• Draft Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays
• Draft Guidance for Industry and FDA Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Helicobacter pylori
• Draft Guidance for Industry and Food and Drug Administration Staff - Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays
• Guidance for Industry, FDA, and Foreign Governments: FY 2011 Medical Device User Fee Small Business Qualification and Certification
• Guidance for Industry and FDA Staff - Impact-Resistant Lenses: Questions and Answers
• Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers

Third Quarter (April 2010 – June 2010) — Seven Publications

• Guidance for Industry and FDA Staff: In Vitro Diagnostic (IVD) Device Studies - Frequently Asked Questions
• Draft Guidance for Industry and FDA Staff: User Fees for 513(g) Requests for Classification Information
• Draft Guidance for Industry and FDA Staff: FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act
• Guidance for Industry and FDA Staff - Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems
• Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials
• Medical Device Tracking; Guidance for Industry and FDA Staff

Second Quarter (January 2010 - March 2010)

• Draft Guidance for Industry and FDA Staff: Heart Valves - Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications

First Quarter (October 2009 - December 2009) - Nine publications

• Guidance for Industry and FDA Staff- In Vitro Diagnostic 2009 H1N1 Tests for Use in the 2009 H1N1 Emergency
• Draft Guidance for Industry and FDA Staff: Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions
• Draft Guidance for Industry and FDA Staff: Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions
• Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Cardiac Allograft Gene Expression Profiling Test Systems
• Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Wound Dressing with Poly(diallyl dimethyl ammonium chloride) (pDADMAC) Additive
• Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Assays
• Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay
• Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays
• Guidance for Industry and FDA Staff - Implementation of Medical Device Establishment Registration and Device Listing Requirements Established by the Food and Drug Administration Amendments Act of 2007