| Identifiant | Dénomination | Date de MaJ | Lien |
| 1680 | Radiation Safety Considerations for X-Ray Equipment Designed for Hand-Held Use
| 24/12/2008 | PDF
|
1628
| Class II Special Controls Guidance Document: Tissue Expander | 22/12/2008
| PDF |
1615
| Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile | 12/12/2008
| PDF
|
1584
| Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process | 11/12/2008
| PDF
|
560
| Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers | 09/09/2008
| PDF
|
1685
| Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment | 21/08/2008
| PDF
|
169
| Medical Device Tracking; Guidance for Industry and FDA Staff
| 15/08/2008
| PDF
|
1678
| Clinical Study Designs for Catheter Ablation Devices for Treatment of Atrial Flutter
| 05/08/2008
| PDF
|
1547
| Class II Special Controls Guidance Document: Bone Sonometers
| 17/07/2008
| PDF
|
1189
| Intravascular Administration Sets Premarket Notification Submissions [510(k)]
| 11/07/2008 | PDF
|
1141
| Surveillance and Detention Without Physical Examination of Surgeons’ and/or Patient Examination Gloves
| 11/07/2008
| PDF
|
1139
| Surveillance and Detention Without Physical Examination of Condoms
| 11/07/2008
| PDF
|
1218
| FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals
| 30/06/2008
| PDF |
1608
| Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters
| 30/05/2008
| PDF
|
1616
| Class II Special Controls Guidance Document: Full Field Digital Mammography System
| 30/05/2008
| PDF |
1630
| Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin
| 30/05/2008
| PDF
|
1617
| Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions
| 30/05/2008
| PDF |
169
| Medical Device Tracking; Guidance for Industry and FDA Staff
| 23/05/2008
| PDF |
| 1646 | Class II Special Controls Guidance Document: Plasmodium Species Antigen Detection Assays
| 20/05/2008
| PDF
|
1143
| Administrative Procedures for CLIA Categorization | 07/05/2008 | PDF |
| 1649 | Hemodialysis Blood Tubing Sets - Premarket Notification [510(k)] Submissions | 23/04/2008 | PDF |
| 1650 | Investigational Device Exemptions (IDEs) for Devices Indicated for Nocturnal Home Hemodialysis | 15/04/2008 | PDF |
| 1637 | Preparation and Review of Investigational Device Exemption Applications (IDEs) for Total Artificial Discs | 11/04/2008 | PDF |
|
1655
| Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements
| 28/02/2008
| PDF
|
-
| Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products
| 25/02/2008 | PDF
|
1658
| Coronary and Carotid Embolic Protection Devices - Premarket Notification [510(k)] Submissions | 15/02/2008
| PDF
|
1638
| Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses | 15/02/2008
| PDF
|
1171
| Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices
| 30/01/2008
| PDF |
1661
| Medical Glove Guidance Manual | 22/01/2008 | PDF
|
| 1566 | The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations | 08/01/2008 | PDF |
| 1602 | The Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program | 08/01/2008 | PDF |