Recent Guidance Documents

Title	Organization	Doc #	Date
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff	CDRH/OIR CDRH/ODE CBER	1825	06/14/13
Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff - FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations (PDF) (PDF - 564KB)	CDRH CBER	1783	06/14/13
Guidance for Industry and Food and Drug Administration Staff - Priority Review of Premarket Submissions for Devices	CBER CDRH	108	05/17/13
Center for Devices and Radiological Health Appeals Processes - Guidance for Industry and Food and Drug Administration Staff	OCD	1742	05/17/13
Center for Devices and Radiological Health Appeals Processes: Questions and Answers About 517A - Draft Guidance for Industry and Food and Drug Administration Staff	OCD	1821	05/17/13
Assay Migration Studies for In Vitro Diagnostic Devices - Guidance for Industry and FDA Staff (PDF - 1.2MB)	CDRH/OIR, CBER	1660	04/25/13
Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 522KB)	ODE	1811	04/23/13
Medical Device Classification Product Codes - Guidance for Industry and Food and Drug Administration Staff	CDRH CBER	1774	04/11/13
Molecular Diagnostic Instruments with Combined Functions - Draft Guidance for Industry and Food and Drug Administration Staff	CDRH/OIR CBER	1763	04/09/13
Guidance for Industry and Food and Drug Administration Staff - User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications	CDRH CBER	1681	04/02/13
Guidance for Industry and Food and Drug Administration Staff - User Fees and Refunds for Premarket Notification Submissions (510(k)s)	CDRH CBER	1511	04/02/13
Guidance for Industry and Food and Drug Administration Staff - Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi	OIR	1721	03/28/13
Draft Guidance for Industry and Food and Drug Administration Staff - Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex	CDRH CDER CBER CVM	1768	03/11/13
Guidance for Industry and FDA Staff - Investigational Device Exemption (IDE) Guidance for Retinal Prostheses	OSEL ODE	1809	03/06/13
Types of Communication During the Review of Medical Device Submissions - Draft Guidance for Industry and Food and Drug Administration Staff	CDRH CBER	1804	03/05/13
Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff	ODE/DGAICDD/ARDB	1605	03/04/13
Financial Disclosure by Clinical Investigators- Guidance for Clinical Investigators , Industry, and FDA Staff (PDF - 165KB)	Financial Disclosure by Clinical Investigators		02/26/13
Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements - Draft Guidance for Industry and Food and Drug Administration Staff	OC/RDMO/RB	1819	02/22/13
Draft Guidance for Industry and Food and Drug Administration Staff - Providing Information about Pediatric Uses of Medical Devices Under Section 515A of the Federal Food, Drug, and Cosmetic Act	CDRH CBER	1801	02/19/13
Accreditation and Reaccreditation Process for Firms under the Third Party Review Program: Part I - Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Reviewers	OIR ODE	1815	02/15/13
Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation - Guidance for Industry and Food and Drug Administration Staff	ODE/DCD/CEMB	1708	02/15/13
Draft Guideline for Industry and Food and Drug Administration Staff - Class II Special Controls Guideline: Temporary Mandibular Condyle Reconstruction Plate	ODE	1799	02/07/13
Guidance for Industry and Food and Drug Administration Staff - Refuse to Accept Policy for 510(k)s (PDF - 1.4MB)	CDRH CBER	1793	12/31/12
Guidance for Industry and Food and Drug Administration Staff - Acceptance and Filing Review for Premarket Approval Applications (PMAs) (PDF - 370KB)	CDRH CBER	1792	12/31/12
Guidance for Industry and Food and Drug Administration Staff - eCopy Program for Medical Device Submissions (PDF - 605KB)	CDRH	1797	12/31/12
IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed (PDF - 62KB)	CBER CDER CDRH		11/20/12
Guidance for Industry and Food and Drug Administration Staff - The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Artificial Pancreas Device Systems (PDF - 847KB)	CDRH	1759	11/09/12
Draft Guidance for Industry and Food and Drug Administration Staff - Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices	OIVD/DMD	1803	11/09/12
Guidance for Industry and Food and Drug Administration Staff - FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals	CBER CDRH	1219	10/15/12
Guidance for Industry and Food and Drug Administration Staff - FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals	CBER CDRH	1208	10/15/12
Guidance for Industry and Food and Drug Administration Staff and Foreign Governments - FY 2013 Medical Device User Fee Small Business Qualification and Certification (PDF - 319KB)	CDRH CBER	2013	08/01/12
Draft Guidance for Industry and Food and Drug Administration Staff - Safety Considerations for 510(k) Submissions to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications	ODE/DRGURD	1784	07/27/12