Recent Medical Device Guidance Documents

Title	Organization	Doc #	Date
Draft Guidance for Industry and Food and Drug Administration Staff - Medical Device Classification Product Codes	CDRH CBER	1774	01/03/12
Draft Guidance for Industry and Food and Drug Administration Staff - CDRH Appeals Processes	OCD	1742	12/27/11
Draft Guidance for Industry and Food and Drug Administration Staff - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]	CDRH/ODE CBER	1766	12/27/11
Guidance for Industry and Food and Drug Administration Staff - Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices	CDRH/OIVD	1752	12/20/11
Draft Guidance for Industry and Food and Drug Administration Staff - Evaluation of Sex Differences in Medical Device Clinical Studies	OCD	1727	12/19/11
Draft Guidance- Humanitarian Use Device (HUD) Designations (PDF - 79KB)	FDA Staff- Humanitarian Use Device (HUD) Designations; HDE, HUD
Draft Guidance for Industry and Food and Drug Administration Staff - The Content of Investigational Device Exemption (IDE) and Premarket Applications for Artificial Pancreas Device Systems	ODE	1786	12/06/11
Guidance for Industry and Food and Drug Administration Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses	OIVD/DMD	1740	11/28/11
Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff - FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations	CDRH CBER	1783	11/10/11
Draft Guidance for Industry and Food and Drug Administration Staff - Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies	ODE OIVD	1782	11/10/11
Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: In Vitro Diagnostic Devices for Yersinia spp. Detection	OIVD/DMD	1714	11/07/11
Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: External Pacemaker Pulse Generator	ODE/DCD	1769	10/17/11
Draft Guidance for Industry and Food and Drug Administration Staff - De Novo Classification Process (Evaluation of Automatic Class III Designation)	CDRH CBER	1760	10/03/11
Draft Guidance for Industry and Food and Drug Administration Staff - Postmarket Surveillance Under Section 522 of the Federal Food, Drug and Cosmetic Act	OSB	1754	08/16/11
Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff - Design Considerations for Pivotal Clinical Investigations for Medical Devices	CDRH/ODE CDRH/OIVD CBER	1776	08/15/11
Draft Guidance for Industry and Food and Drug Administration Staff - Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review	CDRH CBER	1772	08/15/11
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays	OIVD/DMD	1713	08/09/11
Guidance for Industry and Food and Drug Administration Staff and Foreign Governments - FY 2012 Medical Device User Fee Small Business Qualification and Certification (PDF - 351KB)	CDRH CBER	2012	08/01/11
Guidance for Industry and FDA Staff - 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device	CDRH CBER	1793	07/27/11
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems	ODE	1728	07/26/11
Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Electrocardiograph Electrodes	ODE/DCD/CEMB	1597	07/21/11
Draft Guidance for Industry and Food and Drug Administration Staff - Mobile Medical Applications	CDRH CBER	1741	07/21/11
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use	ODE/DSORD	1701	07/20/11
Guidance for Industry and FDA Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses	OIVD/DMD	1638	07/15/11
Draft Guidance for Industry and Food and Drug Administration Staff - In Vitro Companion Diagnostic Devices	CDRH CBER CDER	1737	07/14/11
Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design	ODE	1757	06/22/11
Draft Guidance for Industry and Food and Drug Administration Staff - The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Low Glucose Suspend (LGS) Device Systems	CDRH/ODE	1759	06/22/11
Draft Guidance for Industry and FDA Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of methicillin-resistant Staphylococcus aureus (MRSA) for Culture Based Devices	OIVD/DMD	1729	06/15/11
Draft Guidance for Industry and FDA Staff - Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions	CDRH/OIVD CBER	1723	06/01/11