| Identifiant |
Dénomination |
Date de MaJÂ |
Lien |
| 1706 |
In Vitro Diagnostic 2009 H1N1 Tests for Use in the 2009 H1N1 Emergency
|
06/11/09 |
PDF |
1698
|
Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions (draft guidance) |
21/10/09
|
PDF
|
1697
|
Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions (draft guidance) |
21/10/09
|
PDF
|
1686
|
Class II Special Controls Guidance Document: Cardiac Allograft Gene Expression Profiling Test Systems
|
21/10/09
|
PDF
|
1684
|
Class II Special Controls Guidance Document: Wound Dressing with Poly(diallyl dimethyl ammonium chloride) (pDADMAC) Additive
|
16/10/09
|
PDF
|
1673
|
Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays
|
09/10/09
|
PDF
|
1672
|
Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assays. |
09/10/09
|
PDF
|
1669
|
Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay
|
09/10/09
|
PDF |
1695
|
The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #13 (draft guidance)
|
09/10/09
|
PDF
|
1657
|
Implementation of Medical Device Establishment Registration and Device Listing Requirements Established by the Food and Drug Administration Amendments Act of 2007
|
08/10/09
|
PDF |
1708
|
Clinical Study Designs for Surgical Ablation Devices for Treatment of Atrial Fibrillation (draft guidance) |
14/09/09
|
PDF |
1699
|
Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Human Papillomaviruses
|
09/09/09
|
PDF
|
0631
|
Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems
|
28/08/09
|
PDF
|
1511
|
User Fees and Refunds for Premarket Notification Submissions (510(k)s)
|
27/08/09
|
PDF
|
1679
|
eMDR - Electronic Medical Device Reporting (draft guidance) |
21/08/09
|
PDF
|
| 1200 |
Inspection by Accredited Persons Under The Medical Device User Fee and Modernization Act of 2002 and the FDA Amendments Act of 2007; Accreditation Criteria
|
06/08/09
|
PDF
|
|
1192
|
Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy
|
28/07/09
|
PDF
|
| 1651 |
Investigational Device Exemption (IDE) Guidance for Retinal Prostheses (draft guidance) |
17/04/09
|
PDF
|
| 1681 |
User Fees and Refunds for Premarket Approval Applications (draft guidance) |
13/03/09 |
PDF
|
1532
|
Manufacturer’s Notification of the Intent to Use an Accredited Person under the Accredited Persons Inspection Program Authorized by Section 228 of the Food and Drug Administration Amendments Act of 2007 (FDAAA)
|
02/03/09
|
PDF
|
1696
|
Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products
|
25/02/09 |
PDF
|
848
|
Recommendations for Anti-Nuclear Antibody (ANA) Test System Premarket (510(k)) Submissions
|
22/01/09 |
PDF |
| 1693 |
Designation of Special Controls for Male Condoms Made of Natural Rubber Latex (21 CFR 884.5300); Small entity Compliance Guide
|
05/01/09 |
PDF |
1660
|
Assay Migration Studies for In Vitro Diagnostic Devices (draft guidance)
|
05/01/09
|
PDF
|
1665
|
Class II Special Controls Guidance Document: Nucleic Acid Amplification Assay for the Detection of Enterovirus RNA
|
02/01/09
|
PDF
|