2005 CFR Title 21, Volume 8

Title 21--Food and Drugs CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES
	814.1	Scope.
	814.2	Purpose.
	814.3	Definitions.
	814.9	Confidentiality of data and information in a premarket approval application (PMA) file.
	814.15	Research conducted outside the United States.
	814.17	Service of orders.
	814.19	Product development protocol (PDP).
	814.20	Application.
	814.37	PMA amendments and resubmitted PMA's.
	814.39	PMA supplements.
	814.40	Time frames for reviewing a PMA.
	814.42	Filing a PMA.
	814.44	Procedures for review of a PMA.
	814.45	Denial of approval of a PMA.
	814.46	Withdrawal of approval of a PMA.
	814.47	Temporary suspension of approval of a PMA.
	814.80	General.
	814.82	Postapproval requirements.
	814.84	Reports.
	814.100	Purpose and scope.
	814.102	Designation of HUD status.
	814.104	Original applications.
	814.106	HDE amendments and resubmitted HDE's.
	814.108	Supplemental applications.
	814.110	New indications for use.
	814.112	Filing an HDE.
	814.114	Timeframes for reviewing an HDE.
	814.116	Procedures for review of an HDE.
	814.118	Denial of approval or withdrawal of approval of an HDE.
	814.120	Temporary suspension of approval of an HDE.
	814.122	Confidentiality of data and information.
	814.124	Institutional Review Board requirements.
	814.126	Postapproval requirements and reports.