FDA Guidance Documents

Guidance for Industry and FDA Staff: Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements	December 27, 2007

Guidance for Medical Gloves - A Workshop Manual	December 19, 2007

Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle	November 29, 2007

Guidance for Industry and FDA Staff - Recognition and Use of Consensus Standards	November 15, 2007

Guidance for Industry and FDA Staff - CDRH Standard Operating Procedures for the Identification and Evaluation of Candidate Consensus Standards for Recognition	November 15, 2007

Guidance for Industry and FDA Staff - Frequently Asked Questions on Recognition of Consensus Standards	November 15, 2007

Guidance for Industry - Medical Device Tracking; Guidance for Industry and FDA Staff	November 2, 2007

Draft Guidance for Industry and FDA Staff - In Vitro Diagnostic (IVD) Device Studies – Frequently Asked Questions	October 29, 2007

Draft Guidance for Industry and FDA Staff: Impact-Resistant Lenses: Questions and Answers	October 25, 2007

Guidance for Industry - Medical Device Tracking; Guidance for Industry and FDA Staff	October 25, 2007

Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Remote Medication Management System	October 18, 2007

Guidance for Industry, FDA, and Foreign Governments - FY 2008 Medical Device User Fee Small Business Qualification and Certification (PDF)	October 17, 2007

Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Electrocardiograph Electrodes	October 4, 2007

Guidance for Industry and FDA Staff - Biological Indicator (BI) Premarket Notification [510(k)] Submissions	October 4, 2007

Guidance for Industry and FDA Staff - Procedures for Renewal and Amendment of Certain Laser Light Show Variances (Laser Notice 55)	September 27, 2007

Guidance for Industry and FDA Staff - Compliance Guide for Cabinet X-Ray Systems	September 26, 2007

Guidance for Industry and FDA Staff - Non-clinical Information for Femoral Stem Prostheses	September 19, 2007

Guidance for Industry and FDA Staff Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions	September 13, 2007

Guidance for Industry and FDA Staff - Review Criteria for Assessment of Qualitative Fecal Occult Blood In Vitro Diagnostic Devices	August 14, 2007

Guidance for Industry and FDA Staff - Procedures for Handling Post-Approval Studies Imposed by PMA Order	August 8, 2007

Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology	August 2, 2007

Guidance for Industry and FDA Staff - Writing Dear Doctor Letters for Recalls of Implantable Cardioverter Defibrillators (ICDs)	July 31, 2007

Guidance for Industry: Exports Under the FDA Export Reform and Enhancement Act of 1996 (PDF)	July 25, 2007

Draft Guidance for Industry, Clinical Laboratories, and FDA Staff - In Vitro Diagnostic Multivariate Index Assays	July 24, 2007

Draft Guidance for Industry and FDA Staff - Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents	July 18, 2007

Draft Guidance for Industry and FDA Staff - Pulse Oximeters - Premarket Notification Submissions [510(k)s]	July 18, 2007

Guidance for Industry and FDA Staff - Laser Products - Conformance with IEC 60825-1 and IEC 60601-2-22; Guidance for Industry and FDA Staff (Laser Notice No. 50)	July 12, 2007

Draft Guidance for Industry - Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage	July 9, 2007

Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Filtering Facepiece Respirator for Use by the General Public in Public Health Medical Emergencies	July 2, 2007

Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin	July 2, 2007

Guidance for Industry and FDA Staff - Pre-Clinical and Clinical Studies for Neurothrombectomy Devices	June 30, 2007

Guidance for Industry and FDA Staff - Pharmacogenetic Tests and Genetic Tests for Heritable Markers	June 26, 2007

Guidance for Industry and FDA Staff: Performance Standard for Diagnostic X-Ray Systems and Their Major Components; (21CFR 1020.30, 1020.31, 1020.32, 1020.33); Small Entity Compliance Guide	June 19, 2007

Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Intervertebral Body Fusion Device	June 11, 2007

Guidance for Industry and FDA Staff - Assayed and Unassayed Quality Control Material	June 6, 2007

Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis	May 8, 2007

Guidance for Industry and FDA Staff: Dental Handpieces - Premarket Notification [510(k)] Submissions	May 4, 2007

In Vitro Diagnostic Devices to Detect Influenza A Viruses: Labeling and Regulatory Path - Guidance for Industry and FDA Staff	May 4, 2007

Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Computerized Labor Monitoring Systems	April 23, 2007

Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays	April 3, 2007

Approval of Alternate Means of Labeling for Laser Products (Laser Notice 53) - Guidance for Industry and FDA Staff	March 27, 2007

Guidance for Industry and FDA Staff - Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests	March 15, 2007

Draft Guidance for Industry and FDA Staff - Modifications to Devices Subject to Premarket Approval (PMA) - The PMA Supplement Decision-Making Process	March 9, 2007

Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA	March 6, 2007

Draft Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Oxygen Pressure Regulators and Oxygen Conserving Devices	March 6, 2007

Guidance for Industry, MQSA Inspectors, and FDA - The Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #12	February 6, 2007

Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays	January 9, 2007

Draft Guidance for Industry and FDA Staff - Radio-Frequency Wireless Technology in Medical Devices	January 4, 2007

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