Draft Guidance for Industry and Food and Drug Administration Staff - Safety Considerations for 510(k) Submissions to Mitigate the Risks of Misconnections with Small-bore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
|
Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Implanted Blood Access Devices for Hemodialysis
|
ODE/DRGRUD
|
1781
|
06/20/12
|
Guidance for Industry and Food and Drug Administration Staff - FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act
|
CDRH CBER
|
1671
|
04/06/12
|
Guidance for Industry and Food and Drug Administration Staff - User Fees for 513(g) Requests for Information
|
CDRH CBER
|
1709
|
04/06/12
|
Guidance for Industry and FDA Staff - Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications (PDF - 523KB)
|
ODE OIVD
|
1772
|
03/29/12
|
Draft Guidance for Industry and Food and Drug Administration Staff - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]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
|
Draft Guidance for Industry and Food and Drug Administration Staff - The Content of Investigational Device Exemption (IDE) and Premarket Applications for Artificial Pancreas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
|
Draft Guidance for Industry and Food and Drug Administration Staff - Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including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Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: External Pacemaker Pulse Generator
|
ODE/DCD
|
1769
|
10/17/11
|
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
|
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
|
Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design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 - Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
|
CDRH/ODE CBER
|
1644
|
05/02/11
|
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities
|
ODE/DSORD/PRSDB
|
1582
|
04/25/11
|
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use
|
ODE/DSORD/GSDB
|
1735
|
04/14/11
|
Guidance for Industry and FDA Staff - Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence
|
ODE/DRARD/ULDB
|
1636
|
03/08/11
|
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use
|
ODE/DSORD
|
1734
|
02/07/11
|
Draft Guidance for Industry and FDA Staff - Recommended Warning for Surgeon's Gloves and Patient Examination Gloves that Use Powder
|
OSEL ODE/DAGID
|
1704
|
02/07/11
|
Guidance for Industry and Food and Drug Administration Staff - Blood Lancet Labeling
|
ODE/DSORD
|
1732
|
11/29/10
|
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Non-powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy (NPWT)
|
ODE/DSORD/PRSDB
|
1702
|
11/10/10
|
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Tissue Adhesive with Adjunct Wound Closure Device Intended for the Topical Approximation of Skin
|
ODE/DSORD/PRSDB
|
1683
|
11/10/10
|
Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters
|
ODE/DCD/ICDB
|
1608
|
09/08/10
|
Guidance for Industry and Food and Drug Administration Staff - Guidance for the NonâClinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH) (PDF - 442KB)
|
ODE/DRARD/ULDB
|
1724
|
08/17/10
|
Guidance for Industry and Food and Drug Administration Staff - Contact Lens Care Products Labeling
|
ODE/DOENTD/ICNDB
|
1725
|
08/15/10
|
Draft Guidance for Industry and FDA Staff: Heart Valves - Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications
|
ODE/DCD/CSPDB
|
1607
|
01/20/10
|
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator with Limited Output for Pain Relief
|
ODE/DRARD/ULDB
|
1574
|
04/05/10
|
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended
|
ODE/DRARD/ULDB
|
1670
|
04/05/10
|
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Powered Muscle Stimulator with Limited Output for Muscle Conditioning
|
ODE/DRARD/ULDB
|
1580
|
04/05/10
|
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Powered Muscle Stimulator for Rehabilitation
|
ODE/DRARD/ULDB
|
1577
|
04/05/10
|
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Powered Muscle Stimulator with Limited Output for Rehabilitation
|
ODE/DRARD/ULDB
|
1578
|
04/05/10
|
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Stimulator for Aesthetic Purposes
|
ODE/DRARD/ULDB
|
1575
|
04/05/10
|
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Stimulator with Limited Output for Aesthetic Purposes
|
ODE/DRARD/ULDB
|
1576
|
04/05/10
|
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Powered Muscle Stimulator for Muscle Conditioning
|
ODE/DRARD/ULDB
|
1579
|
04/05/10
|
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Cutaneous Electrode
|
ODE/DRARD/ULDB
|
1572
|
04/05/10
|
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Electroconductive Media
|
ODE/DRARD/ULDB
|
1571
|
04/05/10
|
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief
|
ODE/DRARD/ULDB
|
1573
|
04/05/10
|
Guidance for Industry and FDA Staff - Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems
|
ODE/DCD/PVDB
ODE/DCD/ICDB
|
1545
|
04/18/10
|
Guidance for Industry and FDA Staff - Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions
|
ODE/DAGID/GHDB
|
1694
|
04/23/10
|
Guidance for Industry and FDA Staff: General Considerations for Animal Studies for Cardiovascular Devices
|
ODE/DCD
|
1717
|
07/29/10
|