| Identifiant |
Dénomination |
Date de MaJ |
Lien |
| 1715 |
Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Clostridium difficile (draft guidance) |
29/11/10 |
PDF |
| 1732 |
Blood Lancet Labeling |
29/11/10 |
PDF |
| 1695 |
The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #13 |
16/11/10 |
PDF |
| 1702 |
Class II Special Controls Guidance Document: Non-powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy (NPWT)
|
10/11/10 |
PDF |
| 1683 |
Class II Special Controls Guidance Document: Tissue Adhesive with Adjunct Wound Closure Device Intended
for the Topical Approximation of Skin |
10/11/10 |
PDF |
| 1616 |
Class II Special Controls Guidance Document: Full-Field Digital Mammography System |
05/11/10 |
PDF |
| 1703 |
Addition of URLs to Electronic Product Labeling |
30/09/10 |
PDF |
| 1713 |
Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays (draft guidance)
|
28/09/10 |
PDF |
| 1712 |
Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Helicobacter pylori (draft guidance) |
23/09/10 |
PDF |
| 1608 |
Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters
|
08/09/10 |
PDF |
| 23 |
Impact-Resistant Lenses: Questions and Answers |
02/09/10 |
PDF |
| 1724 |
Guidance for the Non‐Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH) |
17/08/10 |
PDF |
| 1725 |
Contact Lens Care Products Labeling |
15/08/10 |
PDF |
| 1654 |
Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays (draft guidance) |
06/08/10 |
PDF |
| 1717 |
General Considerations for Animal Studies for Cardiovascular Devices |
29/07/10 |
PDF |
| 1668 |
Humanitarian Device Exemption (HDE) Regulation: Questions and Answers |
08/07/10 |
PDF |
| 071230 |
In Vitro Diagnostic (IVD) Device Studies -Frequently Asked Questions |
25/06/10 |
PDF |
| 1705 |
Medical Device ISO 13485:2003 Voluntary Audit Report Submission Program (Draft guidance) |
20/05/10 |
PDF |
| 1709 |
User Fees for 513(g) Requests for Classification Information (Draft guidance) |
29/04/10 |
PDF |
| 1671 |
FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act (Draft guidance) |
29/04/10 |
PDF |
| 1588 |
Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable |
25/04/10 |
PDF |
| 1694 |
Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions (Draft guidance) |
23/04/10 |
PDF |
| 1545 |
Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems |
18/04/10 |
PDF |
| 1575 |
Class II Special Controls Guidance Document: Cutaneous Electrode (Draft guidance) |
05/04/10 |
PDF |
| 1571 |
Class II Special Controls Guidance Document: Electroconductive Media (Draft guidance) |
05/04/10 |
PDF |
| 1579 |
Class II Special Controls Guidance Document: Powered Muscle Stimulator for Muscle Conditioning (Draft guidance) |
05/04/10 |
PDF |
| 1577 |
Class II Special Controls Guidance Document: Powered Muscle Stimulator for Rehabilitation (Draft guidance) |
05/04/10 |
PDF |
| 1580 |
Class II Special Controls Guidance Document: Powered Muscle Stimulator with Limited Output for Muscle Conditioning (Draft guidance) |
05/04/10 |
PDF |
| 1578 |
Class II Special Controls Guidance Document: Powered Muscle Stimulator with Limited Output for Rehabilitation (Draft guidance)
|
05/04/10 |
PDF |
| 1573 |
Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief (Draft guidance) |
05/04/10 |
PDF |
| 1670 |
Class II Special Controls Guidance Document: Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use (Draft guidance) |
05/04/10 |
PDF |
| 1575 |
Class II Special Controls Guidance Document: Transcutaneous Electrical Stimulator for Aesthetic Purposes (Draft guidance) |
05/04/10 |
PDF |
| 1576 |
Class II Special Controls Guidance Document: Transcutaneous Electrical Stimulator with Limited Output for Aesthetic Purposes (Draft guidance) |
05/04/10 |
PDF |
| 122045 |
Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: Public Availability of Advisory Committee Members' Financial Interest Information and Waivers |
01/03/10 |
PDF |
| 2006D-0191 |
Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials |
05/02/10
|
PDF
|
| 1607 |
Heart Valves - Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications (draft guidance) |
20/01/10
|
PDF |