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Center for Devices and Radiological Health, U.S. Food and Drug Administration

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Index of CDRH Web Documents

Topics starting with : 0-9 A B C D E F G H I J K L M N O P Q R S T U V W X Y Z Or, enter a word or phrase to search for in document titles : (Search Help) Some additional items of interest can be found on the Consumer Information page.

Labeling
	Alternative to Certain Prescription Device Labeling Requirements
	Device Labeling Guidance #G91-1 (blue book memo)
	Draft Guidance for Hemodialyzer Reuse Labeling
	Draft Guidance for Industry and FDA Staff - Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use
	Draft Report on Medical Device Labeling: Patients' and Lay Caregivers' Medical Device Information and Labeling Needs - Results of Qualitative Research
	FDA Launches a Tool to Create Effective Medical Device Patient Labeling: Seeks FDA-Industry Partnership in Its Use
	FR Notice: Natural Rubber Containing Medical Devices; User Labeling
	Guidance for Industry; Noise Claims in Hearing Aid Labeling; Final
	Guidance on Labeling for Laboratory Tests; Draft
	Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers
	Human Factors Principles for Medical Device Labeling
	Identification of Manufacturer of Medical Devices
	Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203)
	Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitals; Final Guidance for Industry and FDA
	Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance
	Medical Device Labeling Open Public Meeting, Summary
	Memorandum of Understanding Regarding Patient Labeling Review (Blue Book Memo #G96-3)
	National Health Related Items Code - NHRIC
	Policy on Warning Label Required on Sunlamp Products
	Public Meeting on Bar Code Labeling for Medical Products
	Questions and Answers for the FDA Reviewer Guidance: Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities
	Review of Final Draft Medical Device Labeling #P91-4 (blue book memo)
	Section 206 of the Medical Device User Fee and Modernization Act (MDUFMA) (New section 502(f) of the Federal Food, Drug, and Cosmetic Act) Electronic Labeling for Prescription Devices Intended for Use in Health Care Facilities - G03-1
	Uniform Contraceptive Labeling; Final
	Variance for IVD's - Approval of an Alternative Requirement of the User Labeling Requirements for Devices that Contain Dry Natural Rubber
	Write it Right

Laboratory Practice
	Good Clinical Practice in FDA-Regulated Clinical Trials

Lap-Band
	FDA Approves Implanted Stomach Band to Treat Severe Obesity

Laparoscopy Devices
	Guidance ('Guidelines') for Evaluation of Laparoscopic Bipolar and Thermal Coagulators (and Accessories)
	Guidance for the Preparation of a Premarket Notification for Extended Laparoscopy Devices
	Hysteroscopes and Gynecology Laparoscopes - Submission Guidance for a 510(k)
	Hysteroscopes and Laparoscopic Insufflators: Submission Guidance for a 510(k)
	Letter to Medical Device Industry on Endoscopy and Laparoscopy Accessories (Galdi)
	Shielded Trocars and Needles Used for Abdominal Access During Laparoscopy

Lasers
	Application for a Variance from 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device
	Compliance Guide for Laser Products (FDA 86-8260)
	Consolidated Review of Submissions for Lasers and Accessories #G90-1 (blue book memo)
	Cosmetic Laser Surgery: A High-Tech Weapon in the Fight Against Aging Skin
	Dental Laser Facts
	Dental More Gentle with Painless 'Drillings' and Matching Fillings
	FDA Approves Laser for LASIK
	FDA Authorizes Seizure of Unapproved Lasers
	FDA Clears First Laser for Treating Tooth Decay
	FDA Issues Warning on Misuse of Laser Pointers
	Guidance on Electronic Products which Emit Radiation
	Guidance on the Content and Organization of a Premarket Notification for a Medical Laser
	Guidance on the Department of Defense Exemption from the FDA Performance Standard for Laser Products; Guidance for Industry and FDA
	Guide for Preparing Product Reports for Lasers and Products Containing Lasers
	Hair Removal Laser Facts
	Laser Light Show Safety -- Who's Responsibility (FDA 86-8262)
	Laser Products-Conformance with IEC 60825-1, Am.2 and IEC 60601-2-22; Final Guidance for Industry and FDA (Laser Notice 50)
	Lasik Updates
	LASIK Eye Surgery
	Letter to Ophthalmologists about Lasers for Refractive Surgery
	Manufacturers and Users of Lasers for Refractive Surgery
	Reporting Guide for Laser Light Shows and Displays (21-CFR1002) (FDA 88-8140)
	Responsibilities of Laser Light Show Projector Manufacturers, Dealers, and Distributors; Final Guidance for Industry and FDA - Laser Notice 51
	Review of Laser Submissions #G88-1 (blue book memo)
	Revised Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Laser Light Show Products (replaces FDA 82-8127)

LASIK
	FDA Approves Laser for LASIK
	Lasik Updates
	LASIK Eye Surgery
	Vision Correction: Taking a Look at What's New

Latex Allergies
	Latex Allergies: When Rubber Rubs the Wrong Way

Latex Products
	Draft Medical Glove Guidance Manual
	FDA Public Health Advisory: Potential Risk of Spontaneous Combustion in Large Quantities of Patient Examination Gloves
	FR Notice: Natural Rubber Containing Medical Devices; User Labeling
	Guidance for Conducting Stability Testing To Support An Expiration Date Labeling Claim for Medical Gloves; Draft
	Information for a Latex Condom 510(k) Submission for Obstetrics-Gynecology Devices Branch - Draft
	Latex Condoms for Men - Information for 510(k) Premarket Notifications: Use of Consensus Standards for Abbreviated Submissions
	Latex Labeling Letter (Johnson)
	Premarket Notification [510(k)] Submissions for Testing for Skin Sensitization to Chemicals in Natural Rubber Products; Final
	Statement by Elizabeth D. Jacobson Acting Director CDRH, FDA, DHS, Before the Subcommittee on Oversight And Investigations Re: regulations of natural rubber latex gloves
	Surgeon's and Patient Examination Gloves; Reclassification and Medical Glove Guidance Manual Availability; Proposed Rule and Notice
	Testing for Sensitizing Chemicals in Natural Rubber Latex Medical Devices (Addendum to 944)
	Update on the Phase 2 NHANES III Study and Prevalence of Latex-specific IgE Antibodies

Laws
	Compilation of Laws Enforced by the U.S. Food and Drug Administration and Related Statutes
	FDA Modernization Act of 1997
	FDA Modernization Act of 1997: Description of Select Medical Device Provisions
	Information on the Medical Device User Fee and Modernization Act (MDUFMA) of 2002

Lead Containers
	FDA Public Health Notification: Lead Exposure from Dental Films Stored in Lead-Lined Table-top Containers

Lead Exposure
	FDA Public Health Notification: Lead Exposure from Dental Films Stored in Lead-Lined Table-top Containers

Lead Wires and Cables
	Amendment to Guidance on Discretionary Postmarket Surveillance on Pacemaker Leads
	Establishment of a Performance Standard for Electrode Lead Wires and Patient Cables
	FDA Public Health Notification: Diathermy Interactions with Implanted Leads and Implanted Systems with Leads
	FDA Sets New Safety Requirement for Cables and Leads
	Guidance on Electrosurgical Devices and the Application of the Performance Standard for Electrode Lead Wires and Patient Cables
	Guidance on Performance Standard for Lead Wires and Patient Cables
	Guidance to Sponsors on the Development of a Discretionary Postmarket Surveillance Study for Permanent Implantable Cardiac Pacemaker Electrodes (Leads
	Letter to User Facilities Regarding Lead Wires and Patient Cables
	Unsafe Electrode Lead Wires and Patient Cables Used With Medical Devices
	Unsafe Patient Lead Wires and Cables

Least Burdensome
	Draft Guidance on Evidence Models for the Least Burdensome Means to Market
	Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff
	Special Controls Guidance Documents to Reduce Regulatory Burden
	The Least Burdensome Provisions - Activities Related to Implementation
	The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles: Final Guidance for FDA and Industry

Leeches
	FDA Clears Leeches for Use as Medical Device

Lenses
	FDA Talk Paper: ColorMax Lenses
	Impact Resistant Lenses: Questions and Answers (FDA 87-4002)
	Sunglasses, Spectacle Frames, Spectacle Lens and Magnifying Spectacles

Letters to CEOs and Industry
	Latex Labeling Letter (Johnson)
	Letter to Medical Device Manufacturer on Pentium processors
	Letter to the Health Industry Manufacturers Association
	Letters to CEOs and Industry

Leveraging
	CDRH Leveraging Contacts
	Guidance for FDA Staff: The Leveraging Handbook, An Agency Resource for Effective Collaborations
	Leveraging at FDA
	Outside Leveraging at CDRH
	The Leveraging Handbook, An Agency Resource for Effective Collaborations - Draft Guidance for FDA Staff

Lifts (Patient)
	FDA Announces Nationwide Recall of Faulty Patients Lifts
	U.S. Seizes Patient Lifts with Dangerous Defect

Light Sources
	Draft 510(k) Checklist for Endoscopic Light Sources Used in Gastroenterology and Urology

Limulus Amebocyte
	Guideline on Validation of the Limulus Amebocyte Lysate (LAL) Test as an End-Product Endotoxin Test
	Limulus Amebocute Lysate; Reduction of Samples for Testing

Liposuction
	Liposuction Information

Listing
	Establishment Registration and Medical Device Listing
	Registration and Listing for Firms
	Registration and Listing Process Reengineering Team

Lithotripters
	Checklist for Mechanical Lithotripters and Stone Dislodgers used in Gastroenterology and Urology
	Draft Guidance to Firms on Biliary Lithotripsy Studies
	Draft of Suggested Information for Reporting Extracorporeal Shock Wave Lithotripsy Device Shock Wave Measurements
	Guidance for the Content of Premarket Notifications (510(k)s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi
	Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters; Final

Liver Transplantation
	PRO-Trac� II Tacrolimus ELISA Kit - P970025

Lubricating Jelly
	510(k) Checklist for Sterile Lubricating Jelly Used With Transurethral Surgical Instruments

Lumbar Tapered Fusion Device
	FDA Approves First Device to Utilize Genetically Engineered Protein to Treat Degenerative Disc Disease

Lung Cancer
	FDA Approves New Surgical Sealant for Lung Cancer
	FDA Licenses Diagnostic Agent for Lung Cancer

Lyme Disease
	FDA Clears New Test for Lyme Disease
	FDA Public Health Advisory: Assays for Antibodies to Borrelia burgdorferi; Limitations, Use, and Interpretation for Supporting a Clinical Diagnosis of Lyme Disease
	Lyme Disease Test Kits: Potential for Misdiagnosis
	Lyme Disease: Difficult to Diagnose
	New Vaccine Targets Lyme Disease; New Hope for Diminishing 'Great Masquerader'

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Center for Devices and Radiological Health / CDRH