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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.

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
	A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures; Guidance for Industry and FDA Staff
	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	Draft Guidance: Likelihood of Facilities Inspections When Modifying Devices Subject to Premarket Approval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

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Center for Devices and Radiological Health / CDRH