- Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics - Draft Guidance for Industry and Food and Drug Administration Staff
- The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] - Guidance for Industry and Food and Drug Administration Staff
- Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A - Guidance for Industry and Food and Drug Administration Staff
- FY 2015 Medical Device User Fee Small Business Qualification and Certification - Guidance for Industry, Food and Drug Administration Staff and Foreign Governments
- Design Considerations for Devices Intended for Home Use - Guidance for Industry and Food and Drug Administration Staff
- In Vitro Companion Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff
- De Novo Classification Process (Evaluation of Automatic Class III Designation) - Draft Guidance for Industry and Food and Drug Administration Staff
- Unique Device Identification System: Small Entity Compliance Guide - Guidance for Industry and Food and Drug Administration Staff
- FDA Decisions for Investigational Device Exemption Clinical Investigations - Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff
- Evaluation of Sex-Specific Data in Medical Device Clinical Studies - Guidance for Industry and Food and Drug Administration Staff
- Unique Device Identifier System: Frequently Asked Questions, Vol. 1 - Guidance for Industry and Food and Drug Administration Staff
- Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices - Guidance for Industry and Food and Drug Administration Staff
- Class II Special Controls Guideline: Dengue Virus Nucleic Acid Amplification Test Reagents - Guideline for Industry and Food and Drug Administration Staff
- Class II Special Controls Guideline: Tryptase Test System as an Aid in the Diagnosis of Systemic Mastocytosis - Guideline for Industry and Food and Drug Administration Staff
- Policy Clarification for Certain Fluoroscopic Equipment Requirements - Draft Guidance for Industry and Food and Drug Administration Staff
- Custom Device Exemption - Guidance for Industry and Food and Drug Administration Staff
- Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices - Draft Guidance for Industry and Food and Drug Administration Staff
- Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories - FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs)
- Draft Guidance for Industry, Food and Drug Administration Staff, and Clinical Laboratories - Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff
Want to know more about other recently released FDA Guidance Documents? Please see my previous blogs:
And to get the latest information for 2015:
New FDA Medical Device Guidance Documents for the 1st Quarter 2015
