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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 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
	A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures; Guidance for Industry and FDA Staff
	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

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Center for Devices and Radiological Health / CDRH