| Guidance
for Industry and FDA Staff: Replacement Reagent and Instrument Family
Policy |
December 30, 2003
|
| Premarket
Notification [510(k)] Submissions for Chemical Indicators: Guidance for
Industry and FDA Staff |
December 18, 2003
|
| Class
II Special Controls Guidance Document: Human Dura Mater; Guidance for
Industry and FDA |
December 18, 2003
|
| Premarket
Submission and Labeling Recommendations for Drugs of Abuse Screening Tests
- Draft Guidance for Industry and FDA Staff |
December 2, 2003
|
| Class
II Special Controls Guidance Document: Dental Sonography and Jaw Tracking
Devices - Guidance for Industry and FDA Staff |
December 2, 2003
|
| Draft
Guidance for Industry and FDA Staff; Class II Special Controls Guidance
Document: Dental Precious Metal Alloys |
December 2, 2003
|
| Bundling
Multiple Devices or Multiple Indications in a Single Submission - Guidance
for Industry and FDA Staff |
November 21, 2003
|
| Guidance
for Industry and FDA; The Mammography Quality Standards Act Final
Regulations Modifications and Additions to Policy Guidance Help System #8 |
October 31, 2003
|
| Premarket
Approval Application Modular Review - Guidance for Industry and FDA Staff |
October 31, 2003
|
| Class
II Special Controls Guidance Document: Endotoxin Assay |
October 30, 2003
|
| Guidance
for Industry and FDA Staff - Class II Special Controls Guidance Document:
Serological Reagents for the Laboratory Diagnosis of West Nile Virus |
October 29, 2003
|
| Draft
Guidance for Industry and FDA Staff - Use of Symbols on Labels and in
Labeling of In Vitro Diagnostic Devices Intended for Professional Use |
October 28, 2003
|
| Class
II Special Controls Guidance Document: Arrhythmia Detector and Alarm |
October 27, 2003
|
| FDA
and Industry Actions on Premarket Approval Applications (PMAs): Effect on
FDA Review Clock and Performance Assessment - Guidance for Industry and
FDA Staff |
October 8, 2003
|
| Information
Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems -
Guidance for Industry and FDA Staff |
September 8, 2003
|
| Part
11, Electronic Records; Electronic Signatures - Scope and Application -
Guidance for Industry (Multi-Center Guidance) |
September 5, 2003
|
| Guidance
for Industry and FDA Staff on the Mammography Quality Standards Act Final
Regulations Modifications and Additions to Policy Guidance Help System #6 |
August 19, 2003
|
| Frequently
Asked Questions about the Reprocessing and Reuse of Single-Use Devices by
Third-Party and Hospital Reprocessors; Three Additional Questions -
Guidance for Industry, FDA Staff, Third-Party and Hospital Reprocessors |
August 7, 2003
|
| Implantable
Middle Ear Hearing Device - Guidance for Industry and FDA Staff |
July 31, 2003
|
| Guidance
for Industry and FDA Staff: Class II Special Controls Guidance Document:
Breast Lesion Documentation System (Issue Date 7/28/03) |
July 25, 2003
|
| Coronary
and Peripheral Arterial Diagnostic Catheters - Guidance for Industry and
FDA Staff |
July 18, 2003
|
| Criteria
for Significant Risk Investigations of Magnetic Resonance Diagnostic
Devices - Guidance for Industry and FDA Staff |
July 15, 2003
|
| Guidance
for Industry and FDA Staff on Class II Special Controls Guidance Document;
Breath Nitric Oxide Test System |
July 3, 2003
|
| Medical
Device User Fee and Modernization Act of 2002, Validation Data in
Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use
Medical Devices - Guidance for Industry and FDA Staff |
June 3, 2003
|
| 510(k)
Submissions for Coagulation Instruments - Guidance for Industry and FDA
Staff |
June 30, 2003
|
| A
Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for
Premarket Procedures - Guidance for Industry and FDA |
June 25, 2003
|
| Compliance
with Section 301 of the Medical Device User Fee and Modernization Act of
2002 - Identification of Manufacturer of Medical Devices - Draft Guidance
for Industry and FDA Staff |
June 23, 2003
|
| Compliance
with Section 301 of the Medical Device User Fee and Modernization Act of
2002 - Identification of Manufacturer of Medical Devices - Draft Guidance
for Industry and FDA Staff |
June 20, 2003
|
| Class
II Special Controls Guidance Document: Surgical Sutures; Guidance for
Industry and FDA |
May 30, 2003
|
| Guidance
for Industry and FDA Staff: Pediatric Expertise for Advisory Panels |
May 30, 2003
|
| Class
II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void
Filler Device; Guidance for Industry and FDA - Guidance for Industry and
FDA Staff |
May 28, 2003
|
| Draft
Guidance for Industry and FDA; Surgical Masks--Premarket Notification
Submissions |
May 14, 2003
|
| Medical
Device Tracking - Guidance for Industry and FDA Staff |
May 12, 2003
|
| Premarket
Approval Application Filing Review - Guidance for Industry and FDA Staff |
May 2, 2003
|
| Related
Document: Implementation of the Inspection by Accredited Persons Program
Under The Medical Device User Fee and Modernization Act of 2002;
Accreditation Criteria: Guidance for Industry, FDA Staff, and Third
Parties |
April 28, 2003
|
| Implementation
of the Inspection by Accredited Persons Program Under The Medical Device
User Fee and Modernization Act of 2002; Accreditation Criteria: Guidance
for Industry, FDA Staff, and Third Parties |
April 24, 2003
|
| Related
Document: Class II Special Controls Guidance Document: Optical Impression
Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental
Restorations; Guidance for Industry and FDA |
April 22, 2003
|
| Multiplex
Tests for Heritable DNA Markers, Mutations and Expression Patterns; Draft
Guidance for Industry and FDA Reviewers |
April 21, 2003
|
| Supporting
Statement : Agency Information Collection Activities; Announcement of OMB
Approval; Medical Device Reporting: Manufacturer Reporting, Importer
Reporting, User Facility Reporting, and Distributor Reporting |
April 21, 2003
|
| User
Labeling for Devices that Contain Natural Rubber (21 CFR 801.437); Small
Entity Compliance Guide; Guidance for Industry |
April 10, 2003
|
| Guidance
for FDA Staff on Detention Without Physical Examination of Decorative
Contact Lenses (Import Alert #86-10). (Note - This is an ORA Guidance) |
April 4, 2003
|
| Guidance
for FDA Staff: The Leveraging Handbook, An Agency Resource for Effective
Collaborations (FDA Level Guidance) |
March 14, 2003
|
| Statistical
Guidance on Reporting Results from Studies Evaluating Diagnostic Tests;
Draft Guidance for Industry and FDA Reviewers |
March 14, 2003
|
| Analyte
Specific Reagents; Small Entity Compliance Guidance; Guidance for Industry |
March 03, 2003
|
| Assessing
User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy
Supplement Definitions, Bundling Multiple Devices in a Single Application,
and Fees for Combination Products; Guidance for Industry and FDA |
February 21, 2003
|
| Guidance
for Industry and FDA: FY 2003 MDUFMA Small Business Qualification
Worksheet and Certification |
February 21, 2003
|
| Guidance
for Saline, Silicone Gel, and Alternative Breast Implants; Guidance for
Industry and FDA |
February 13, 2003
|
| Class
II Special Controls Guidance Document: Knee Joint Patellofemorotibial and
Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance
for Industry and FDA |
February 7, 2003
|
| The
Mammography Quality Standards Act Final Regulations Modifications and
Additions to Policy Guidance Help System #7; Guidance for Industry and FDA |
February 6, 2003
|
| Related
Document: Class II Special Controls Guidance Document: Antimicrobial
Susceptibility Test (AST) Systems; Guidance for Industry and FDA |
February 5, 2003
|
| Quality
System Information for Certain Premarket Application Reviews; Guidance for
Industry and FDA Staff |
February 3, 2003
|
| Mammography:
Policy Guidance Help System - Updated |
January 24, 2003
|
| FDA
Issues Guidance for Collection of Race and Ethnicity Data in Clinical
Trials for FDA Regulated Products |
January 23, 2003
|
| Guidance
for Industry; Collection of Race and Ethnicity Data in Clinical Trials |
January 23, 2003
|
| Supplementary
Guidance on Premarket Notifications for Medical Devices with Sharps Injury
Prevention Features; Guidance for Industry and FDA |
January 13, 2003
|
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