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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.

Pacemaker
	Cellular Phone Interference
	Consumer Information for the Medtronic InSync Biventricular Pacing System
	Dear Colleague Letter: Interaction Between Minute Ventilation Rate-Adaptive Pacemakers and Cardiac Monitoring and Diagnostic Equipment
	FDA Approves First Pacemaker For Congestive Heart Failure
	FDA Approves New Type of Pacemaker
	Important Information on Anti-Theft and Metal Detector Systems and Pacemakers, ICDs, and Spinal Cord Stimulators

Pacing Systems
	FDA Approves First Pacemaker For Congestive Heart Failure
	FDA Approves New Type of Pacemaker

Pain
	Guidance for Studies for Pain Therapy Devices - General Consideration in the Design of Clinical Studies for Pain-Alleviating Devices

Panel Meetings
	Brochure: Request for Nominations for Members and Consultants to Serve on FDA's Medical Devices Advisory Committee
	Guidance on Amended Procedures for Advisory Panel Meetings; Final
	Industry Representatives on Scientific Panel
	Overview with Links to Upcoming Meetings and Summaries of Recent Meetings
	Panel Report and Recommendations on PMA Approvals #P86-5 (blue book memo)
	Panel Review of 'Me-Too' Devices #P86-6 (blue book memo)
	Panel Review of Premarket Approval Applications #P91-2 (blue book memo)

Parenteral Nutrition
	Hazards of Precipitation Associated With Parenteral Nutrition

Parkinson's Disease
	FDA Approves Expanded Use of Brain Implant for Parkinson's Disease
	FDA Approves Implanted Brain Stimulator to Control Tremors
	Neurological Devices Panel, March 31, 2000 - Bilateral Deep Brain Stimulator

Participating In Clinical Trials
	Clinical Trials of Medical Treatments: Why Volunteer?

Partnership Program
	FDA Public/Private Partnership Program

Patient Examination Gloves
	Draft Medical Glove Guidance Manual
	Guidance for Conducting Stability Testing To Support An Expiration Date Labeling Claim for Medical Gloves; Draft
	Surgeon's and Patient Examination Gloves; Reclassification and Medical Glove Guidance Manual Availability; Proposed Rule and Notice

Patient Safety
	FDA Patient Safety News for Health Care Personnel
	Final Summary of Food and Drug Administration (FDA) Action Items - Doing What Counts for Patient Safety: Federal Actions to Reduce Medical Errors and Their Impact

PDP
	PDP - see Product Development Protocol

Pediatric
	Pediatric Medical Devices
	Premarket Assessment of Pediatric Medical Devices - Guidance for Industry and FDA Staff
	Presentation/Transcript - American Academy of Pediatrics: Improving the Availability of Pediatric Devices - June 28, 2004

Pelvic
	Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery; Guidance for Industry

Penalties
	Civil Money Penalty Policy
	Reduction of Civil Money Penalties for Small Entities; Guidance for Industry and FDA Staff

Penile Devices
	CDRH Interim Regulatory Policy for External Penile Rigidity Devices
	Draft Guidance for Preparation of PMA Applications for Penile Inflatable Implants
	Guidance for the Content of Premarket Notifications for Penile Rigidity Implants; Final

Performance Plans
	FDA Performance Plan FY2002 - Medical Devices and Radiological Health
	FDA's FY 2001 Performance Plan, FY 2000 Final Performance Plan, and FY 1999 Performance Report for Medical Devices and Radiological Health

Pesticides
	Pesticide Regulation Notice 94-4 Interim Measures for the Registration of Antimicrobial Products/Liquid Chemical Germicides with Medical Device Use Claims

Petitions
	CDRH Petitions

Photon-emitting Devices
	Guidance for the Submission of Premarket Notifications for Photon-Emitting Brachytherapy Sources

Photorefractive Keratectomy (PRK)
	FDA Approves Laser for LASIK
	Lasik Updates
	LASIK Eye Surgery
	Summary Information for LaserScan LSX Excimer Laser System for Photorefractive Keratectomy for Myopia

Picture Archiving and Communications Systems (PACS)
	Guidance for the Submission of Premarket Notifications for Medical Image Management Devices

PMA
	PMA - See Premarket Approval

Pneumonia
	FDA Clears Quick New Lab Test for Pneumonia Antigen

Policy Development
	Policy Development and Review Procedures #I90-1 (blue book memo)

Polymer Implants
	Guidance Document for Testing Biodegradable Polymer Implant Devices

Porous Coated
	Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis

Portable Document Format (PDF) Reader
	Helpful Tips for CDRH Documents in PDF Format
	Instructions for Downloading Portable Document Format (PDF) Reader

Postmarket Surveillance
	Amendment to Guidance on Discretionary Postmarket Surveillance on Pacemaker Leads
	Appendix A: Final Report of a Study To Evaluate the Feasibility and Effectiveness of a Sentinel Reporting System for Adverse Event Reporting of Medical Device Use in User Facilities
	Designing a Medical Device Surveillance Network: A Report To Congress
	Guidance on Criteria and Approaches for Postmarket Surveillance
	Guidance on Procedures for Review of Postmarket Surveillance Submissions
	Guidance on Procedures to Determine Application of Postmarket Surveillance Strategies
	Presentation: Gaps in Your Postmarket Safety Net for Medical Devices
	SMDA to FDAMA: Guidance on FDA's Transition Plan for Existing Postmarket Surveillance
	The Role of Clinical Data in Postmarket Surveillance of Cardiovascular Devices - Workshop Summary

Powered Muscle Stimulators
	Guidance Document for Powered Muscle Stimulator 510(k)s; Final

Pre-IDE
	Pre-IDE Program: Issues and Answers - Blue Book Memo D99-1

Preamendments Devices
	515(i) Reclassification Letter to Manufacturers
	Document Required for Preamendment Status
	Preamendment Class III Devices
	Preamendments Class III Strategy

Pregnancy
	Pregnancy Home Use Test

Premarket Approval
	Blue Book Memoranda - PMA
	PMA Modular Submission Cover Sheet at HIMA Website
	30-Day Notices and 135-Day PMA Supplements for Manufacturing Method or Process Changes (2/19/98) (P98-4)
	30-Day Notices and 135-day PMA Supplements for Manufacturing Method or Process Changes, Guidance for Industry and CDRH (Docket 98D-0080); Final
	4-of-A-Kind PMAs
	Acceptance of Foreign Clinical Studies; Guidance for Industry
	Bundling Multiple Devices or Multiple Indications in a Single Submission - Guidance for Industry and FDA Staff
	Clinical Utility and Premarket Approval #P91-1 (blue book memo)
	Continued Access to Investigational Devices During PMA Preparation and Review (Blue Book Memo) (D96-1)
	Criteria for Panel Review of PMA Supplements #P86-3 (blue book memo)
	Device Advice: PMA Supplements and Amendments
	Distribution and Public Availability of PMA Summary of Safety and Effectiveness Data Packages
	Draft Guidance: Likelihood of Facilities Inspections When Modifying Devices Subject to Premarket Approval
	Early Collaboration Meetings Under the FDA Modernization Act (FDAMA) (2/19/98 (P98-3)
	Expedited Review of Premarket Submissions for Devices - Guidance for Industry and FDA Staff
	FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Performance Assessment - Guidance for Industry and FDA Staff
	FDA Launches Initiative to Improve the Development and Availability of Innovative Medical Products
	Guidance on PMA Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies (2/19/1998) (P98-2)
	Guidance on PMA Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies - for Use by CDRH and Industry; Final
	Guidance on Section 216 of the Food and Drug Administration Modernization Act of 1997
	Guidance to Industry Supplements to Approved Applications for Class III Medical Devices: Use of Published Literature, Use of Previously Submitted Materials, and Priority Review; Final
	Improving Innovation in Medical Technology: Beyond 2002
	Improving Innovation in Medical Technology: Beyond 2002 - Executive Summary
	In Vitro Diagnostic Model for a Pilot for Streamlined PMA Review
	Information About Applications with a Link to Releasable PMAs
	Letter to IVD Manufacturers on Streamlined PMA; Final
	Modifications to Devices Subject to Premarket Approval - The PMA Supplement Decision Making Process; Draft
	New IDE / PMA Development and Review Model and Pilots
	New Model Medical Device Development Process; Final
	Panel Review of Premarket Approval Applications #P91-2 (blue book memo)
	PMA Compliance Program #P91-3 (blue book memo)
	PMA Review Schedules (P87-1) Replaced by P94-2
	PMA Review Statistical Checklist
	PMA Supplements: ODEs letter to manufacturers; identifies situations which may require the submission of a PMA supplement (When PMA Supplements are Required) #P90-1 (blue book memo)
	PMA Transformation Team Home Page
	PMA/510(k) Triage Review Procedures #G94-1 (blue book memo)
	PMAs - Early Review and Preparation of Summaries of Safety and Effectiveness #P86-1 (blue book memo)
	Premarket Approval (PMA) Manual
	Premarket Approval Application (PMA) Closure #P94-2 (blue book memo)
	Premarket Approval Application Content Shell
	Premarket Approval Application Filing Review - Guidance for Industry and FDA Staff

	Premarket Approval Application Modular Review - Guidance for Industry and FDA Staff
	Premarket Approval Applications (PMA) for Absorbable Powder for Lubricating a Surgeon�s Glove - Guidance for Industry and FDA Staff
	Premarket Approval Search Engine
	Premarket Assessment of Pediatric Medical Devices - Guidance for Industry and FDA Staff
	Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff
	Real-Time Review Program for Premarket Approval Application (PMA) Supplements
	Review and Approval of PMAs of Licensees #P86-4 (blue book memo)
	SMDA Changes - PMA Manual Insert
	Threshold Assessment of the Impact of Requirements for Submission of PMAs for 31 Medical Devices Marketed Prior to May 28, 1976
	User Fees and Refunds for Premarket Approval Applications - Guidance for Industry and FDA Staff

Premarket Notification (510(k))
	510(k) Manual - Premarket Notification: 510(k) - Regulatory Requirements for Medical Devices
	510(k) Additional Information Procedures #K93-1 (blue book memo)
	510(k) Quality Review Program (blue book memo)
	510(k) Refuse to Accept Procedures #K94-1 (blue book memo)
	510(k) Sign-Off Procedures #K94-2 (blue book memo)
	A New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications
	Center for Biologics Evaluation and Research - Substantially Equivalent 510(k) Device Information
	Center for Devices and Radiological Health's Premarket Notification [510(k)] Refuse to Accept Policy - (updated Checklist 3/14/1995)
	Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1)
	Determination of Intended Use for 510(k) Devices; Guidance for CDRH Staff

	FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment - Guidance for Industry and FDA Staff
	Frequently Asked Questions on the New 510(k) Paradigm; Final
	Guidance for Third Parties and FDA Staff; Third Party Review of Premarket Notifications
	Guidance on the Center for Devices and Radiological Health's Premarket Notification Review Program #K86-3 (blue book memo)
	In Vitro Diagnostic Devices: Guidance for the Preparation of 510(k) Submissions
	Indications for Use Statement
	Information on Releasable 510(k)s
	List of Accredited Persons for 510(k) Review under the FDA Modernization Act of 1997
	Medical Device Exemptions: 510(k) and GMP Requirements
	New section 513(f)(2) - Evaluation of Automatic Class III Designation: Guidance for Industry and CDRH Staff; Final
	PMA/510(k) Triage Review Procedures #G94-1 (blue book memo)
	Premarket Assessment of Pediatric Medical Devices - Guidance for Industry and FDA Staff
	Premarket Notification - Consistency of Reviews #K89-1 (blue Book memo)
	Premarket Notification [510(k)] Status Request Form
	Premarket Submission Cover Sheet
	Procedures for Class II Device Exemptions from Premarket Notification Guidance for Industry and CDRH Staff; Final
	Required Elements for a Declaration of Conformity to a Recognized Standard - (Screening Checklist for All Premarket Notification [510(k)] Submissions)
	Screening Checklist for all Premarket Notification 510(k) Submissions
	Search the Releasable 510(k) Database
	Sec. 300.600 Commercial Distribution with Regard to Premarket Notification [Section 510(k)] [CPG 7124.19]
	SMDA Changes - Premarket Notification; Regulatory Requirements for Medical Devices (510k) Manual Insert
	Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for Industry and FDA
	User Fees and Refunds for Premarket Notification Submissions (510(k)s) - Guidance for Industry and FDA Staff

Premarket Review
	A Systems Approach to Premarket Review

Presentations
	Presentations by CDRH Staff

Process Validation
	Guideline on General Principles of Process Validation

Product Classification
	Product Classification Database

Product Development Protocol (PDP)
	Guidance for Industry - Contents of a Product Development Protocol; Draft
	Product Development Protocol

Product Evaluation
	Documentation and Resolution of Differences of Opinion on Product Evaluations #G93-1 (blue book memo)

Prostate
	Draft Guidance for Clinical Investigations of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH)
	Elecsys� Free PSA Immunoassay, Elecsys� Free PSA CalSet, Elecsys� Free PSA CalCheck P000027
	FDA Approves New Device to Treat Enlarged Prostate
	FDA Approves Test for Prostate Cancer
	FDA Public Health Notification: Serious Injuries from Microwave Thermotherapy for Benign Prostatic Hyperplasia
	Prostate Cancer: No One Answer for Testing or Treatment
	Summary Information on Elecsys � Total PSA Immunoassay and Total PSA Calset - P990056

Prostate Cancer
	Elecsys� Free PSA Immunoassay, Elecsys� Free PSA CalSet, Elecsys� Free PSA CalCheck P000027
	FDA Approves New Device to Treat Enlarged Prostate
	FDA Approves Test for Prostate Cancer
	FDA Public Health Notification: Serious Injuries from Microwave Thermotherapy for Benign Prostatic Hyperplasia
	Prostate Cancer: No One Answer for Testing or Treatment
	Summary Information on Elecsys � Total PSA Immunoassay and Total PSA Calset - P990056

Prostheses
	Avanta Metacarpophalangeal (MCP) Joint Implant Finger Prosthesis

Prothrombin Time
	Prothrombin Time Home Use Test

Publications
	Catalog of FDA Information for Consumers - Publications and Audiovisuals
	FDA & YOU - News for Health Educators and Students
	Mammography Matters
	User Facility Reporting Bulletins

Pumps
	Guidance Document for Powered Suction Pump 510(k)s
	Guidance on the Content of Premarket Notification [510(k)] Submissions for External Infusion Pumps
	Medtronic IsoMed Constant Flow Infusion System

PVC
	Consumer Update - DEHP in Plastic Medical Devices
	FDA Public Health Notification: PVC Devices Containing the Plasticizer DEHP
	Medical Devices Made With Polyvinylchloride (PVC) Using the Plasticizer di-(2-Ethylhexyl)phthalate (DEHP); Draft Guidance for Industry and FDA
	Presentation: PVC and DEHP
	Safety Assessment of di-(2-ethylhexyl)phthalate (DEHP) Released from PVC Medical Devices

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Center for Devices and Radiological Health / CDRH