| |
|
FDA Guidance Documents - Archives
|
FDA Guidance Documents - 2005 Releases
| Guidance for Industry and FDA Staff - Procedures for Handling Post-Approval Studies Imposed by PMA Order |
December 22, 2006 |
|
| Guidance for Industry, FDA Staff, Eye Care Professionals, and Consumers - Decorative, Non-corrective Contact Lenses |
November 24, 2006 |
|
| Guidance for Industry - Medical Device Tracking; Guidance for Industry and FDA Staff |
November 17, 2006 |
|
| Guidance for Industry and FDA Staff - Saline, Silicone Gel, and Alternative Breast Implants |
November 17, 2006 |
|
| Guidance for Industry, FDA Staff, and Third Parties - Provision for Alternate Measure of the Computed Tomography Dose Index (CTDI) to Assure Compliance with the Dose Information Requirements of the Federal Performance Standard for Computed Tomography |
November 17, 2006 |
|
| Guidance for Industry and FDA Staff - Exemption from Certain Reporting and Recordkeeping Requirements for Microwave Ovens |
November 16, 2006 |
|
| Guidance for Industry and FDA Staff - Exemption from Certain Reporting and Recordkeeping Requirements for Television Receivers and Computer Monitors with Cathode Ray Tubes |
November 16, 2006 |
|
| Draft Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Absorbable Hemostatic Device |
October 30, 2006 |
|
| Draft Guidance for Industry and FDA Staff - Annual Reports for Approved Premarket Approval Applications (PMA) |
October 25, 2006 |
|
| Draft Guidance for Industry and FDA Staff - Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems |
October 23, 2006 |
|
| 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 |
September 26, 2006 |
|
| Guidance for Industry and FDA Staff - Keratome and Replacement Keratome Blades Premarket Notification [510(k)] Submissions |
September 25, 2006 |
|
| Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Hepatitis A Virus Serological Assays |
September 18, 2006 |
|
| Draft Guidance for Industry and FDA Staff - Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions |
September 5, 2006 |
|
| Draft Guidance for Industry, Clinical Laboratories, and FDA Staff - In Vitro Diagnostic Multivariate Index Assays |
September 5, 2006 |
|
| FY 2007 MDUFMA Small Business Qualification Worksheet and Certification - Guidance for Industry and FDA |
August 3, 2006 |
|
| Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Fecal Calprotectin Immunological Test Systems |
July 26, 2006 |
|
| Guidance for Industry and FDA Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers |
July 25, 2006 |
|
| Establishment and Operation of Clinical Trial Data Monitoring Committees - Guidance for Clinical Trial Sponsors |
June 23, 2006 |
|
| The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations - Draft Guidance for Industry and FDA Staff |
June 20, 2006 |
|
| The Review and Inspection of Premarket Approval Applications under the Bioresearch Monitoring Program - Draft Guidance for Industry and FDA Staff |
June 20, 2006 |
|
| Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Olfactory Test Device |
June 6, 2006 |
|
| Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials - Draft Guidance for Industry and FDA Staff |
May 22, 2006 |
|
| Real-Time Premarket approval Application (PMA) Supplements - Guidance for Industry and FDA Staff |
May 4, 2006 |
|
| Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended - Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices - Guidance for Industry and FDA Staff
|
May 1 , 2006 |
|
| Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable - Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff |
April 24, 2006 |
|
| The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #9 - Guidance for Industry and FDA |
April 19, 2006 |
|
| In Vitro Diagnostic Devices to Detect Influenza A Viruses: Labeling and Regulatory Path - Guidance for Industry and FDA Staff |
April 7, 2006 |
|
| Topical Oxygen Chamber for Extremities - Class II Special Controls Guidance Document - Draft Guidance for Industry and FDA Staff |
April 5, 2006 |
|
| Dental Curing Lights - Premarket Notification [510(k)] Submissions - Guidance for Industry and FDA Staff |
March 29, 2006 |
|
| Guidance for Industry and FDA Staff: Tonometers - Premarket Notification [510(k)] Submissions |
March 27, 2006 |
|
| Reagents for Detection of Specific Novel Influenza A Viruses : Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document |
March 22, 2006 |
|
| Guidance for Industry and FDA Staff - Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment |
March 9, 2006 |
|
| Bone Sonometers - Class II Special Controls Guidance Document - Draft Guidance for Industry and FDA Staff |
February 14, 2006 |
|
| Implantable Intra-Aneurysm Pressure Measurement System - Class II Special Controls Guidance Document |
February 14, 2006 |
|
| Draft Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Intervertebral Body Fusion Device |
February 8, 2006 |
|
| Draft Guidance for Industry and FDA Staff - Pharmacogenetic Tests and Genetic Tests for Heritable Markers |
February 8, 2006 |
|
| Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Hepatitis A Virus Serological Assays |
February 8, 2006 |
|
| Guidance for Industry and FDA Staff - Exemption from Reporting and Recordkeeping Requirements for Low Power Laser Products (Laser Notice 54) |
January 17, 2006 |
|
| Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays |
January 9, 2006 |
|
|
|
|
