| Vascular
and Neurovascular Embolization Devices - Class II Special Controls Guidance
Document - Guidance for Industry and FDA Staff |
December
30, 2004 |
| Guidance
for Industry and FDA Staff - Class II Special Controls Guidance Document:
Assisted Reproduction Laser Systems |
December
27, 2004 |
| Guidance
for Industry and FDA Staff - Class II Special Controls Guidance Document:
External Penile Rigidity Devices |
December
27, 2004 |
| Class
II Special Controls Guidance Document: Implantable Radiofrequency Transponder
System for Patient Identification and Health Information - Guidance for
Industry and FDA Staff |
December
9, 2004 |
| Clinical
Data Presentations for Orthopedic Device Applications - Guidance for Industry
and FDA Staff |
December
6, 2004 |
| Guidance
for Industry and FDA Staff: Use of Symbols on Labels and in Labeling of
In Vitro Diagnostic Devices Intended for Professional Use |
November
29, 2004 |
| FDA
responds to a request for an extension of the comment period to the draft
guidance "Hospital Bed System Dimensional Guidance to Reduce Entrapment" |
November
22, 2004 |
| Guidance
for Industry and FDA Staff: Frequently Asked Questions (FAQs) on the Status
of Reprocessed Single Use Devices (SUDs) that receive a Not Substantially
Equivalent (NSE) Letter |
November
10, 2004 |
| Guidance
for Third Parties and FDA Staff; Third Party Review of Premarket Notifications |
October
6, 2004 |
| Guidance
for Industry and FDA Staff; Class II Special Controls Guidance Document:
Serological Assays for the Detection of Beta-Glucan |
August
23, 2004 |
| Guidance
for Industry and FDA Staff: Class II Special Controls Guidance Document:
Dental Noble Metal Alloys |
August
20, 2004 |
| Guidance
for Industry and FDA Staff: Class II Special Controls Guidance Document:
Dental Base Metal Alloys |
August
20, 2004 |
| Guidance
for Industry and FDA: FY 2005 MDUFMA Small Business Qualification Worksheet
and Certification |
August
11, 2004 |
| Guidance
for Industry: FDA Export Certificates |
July
13, 2004 |
| A
Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for
Premarket Procedures: Guidance for Industry and FDA Staff |
July
7, 2004 |
| Draft
Guidance for Industry and FDA Staff - Class II Special Controls Guidance
Document: Dental Bone Grafting Material |
June
29, 2004 |
| Draft
Guidance for Industry, Food and Drug Administration Staff, and Food and
Drug Administration-Accredited Third-Parties: Requests for Inspection by
an Accredited Person Under the Inspections by Accredited Persons Program
Authorized by Section 201 of the Medical Device User Fee and Modernization
Act of 2002 |
June
2, 2004 |
| FDA
Talk Paper - FDA Revises Guidance on Reprocessing of Single-Use Devices
- Revisions Clarify FDA's Review Procedures |
June
2, 2004 |
| Guidance
for Industry and FDA Staff: User Fees and Refunds for Premarket Notification
Submissions (510(k)s) |
May
27, 2004 |
| Guidance
for Industry and FDA Staff: Medical Device User Fee and Modernization Act
of 2002, Validation Data in Premarket Notification Submissions (510(k)s)
for Reprocessed Single-Use Medical Devices |
May
27, 2004 |
| Guidance
for Industry and FDA Staff: FDA and Industry Actions on Premarket Notification
(510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment |
May
20, 2004 |
| Class
II Special Controls Guidance Document: Root-form Endosseous Dental Implants
and Endosseous Dental Abutments - Guidance for Industry and FDA Staff |
May
11, 2004 |
| Class
II Special Controls Guidance Document: Immunomagnetic Circulating Cancer
Cell Selection and Enumeration System - Guidance for Industry and FDA Staff |
May
10, 2004 |
| Guidance
for Industry and FDA Staff : Spinal System 510(k)s |
May
7, 2004 |
| Draft
Guidance for Industry: Combination Products, Timeliness of Premarket Reviews:
Dispute Resolution Guidance |
May
4, 2004 |
| Premarket
Approval Applications (PMA) for Absorbable Powder for Lubricating a Surgeon's
Glove - Guidance for Industry and FDA Staff |
April
12, 2004 |
| Consumer
Information on the DeBakey VAD(r) Child - H030003 |
March
16, 2004 |
| Class
II Special Controls Guidance Document: Vascular and Neurovascular Embolization
Devices - Draft Guidance for Industry and FDA Staff (posted 2/24/04) |
February
25, 2004 |
| Class
II Special Controls Guidance Document: Vascular and Neurovascular Embolization
Devices - Draft Guidance for Industry and FDA Staff |
February
24, 2004 |
| Vocal
Fold Medialization Devices - Premarket Notification [510(k)] Submissions
- Guidance for Industry and FDA Staff |
February
17, 2004 |
| Cyanoacrylate
Tissue Adhesive for the Topical Approximation of Skin - Premarket Approval
Applications (PMAs) - Guidance for Industry and FDA Staff |
February
17, 2004 |
| "Help-Seeking"
and Other Disease Awareness Communications by or on behalf of
Drug and Device Firms - Draft Guidance for Industry |
February
4, 2004 |
| Consumer-Directed
Broadcast Advertising of Restricted Devices - Draft Guidance for Industry
and FDA |
February
4, 2004 |
| Clinical
Study Designs for Percutaneous Catheter Ablation for Treatment of Atrial
Fibrillation - Guidance for Industry and FDA Staff |
January
12, 2004 |
| Saline,
Silicone Gel, and Alternative Breast Implants - Draft Guidance for Industry
and FDA Staff |
January
8, 2004 |
|
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