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Medical Device Information


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Ophthalmic Devices Panel Advisory Meeting, June 10, 2008 - Written Comments
submitted by healthnews 694 days ago (via accessdata.fda.gov)
The committee will discuss general issues concerning the postmarket experience with various contact lens care products. The discussion will include recommendations on contact lens care product development topics such as preclinical testing and clini...
 
0 Comments - More Info - Bury   Topic: Medical Device Information
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Registration and Listing (Device Establishment Registration and Listing for FY2009 Now Available)
submitted by healthnews 694 days ago (via fda.gov)
Topics: Device Listing, Establishment Registration, Listing, Registration
 
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Electronic Copies for Pre-Market Submissions (Updated 09/08)
submitted by healthnews 694 days ago (via fda.gov)
The Center for Devices and Radiological Health (CDRH) is accepting and encouraging sponsors of premarket medical device submissions to include a copy of their submission in electronic form along with the required paper copies.
 
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Federal Register: Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
submitted by healthnews 694 days ago (via edocket.access.gpo.gov)
The FDA is is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and...
 
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Summary Information for: NexGen® LPS-Flex Mobile Bearing and LPS-Mobile Bearing Knees
submitted by healthnews 694 days ago (via fda.gov)
PDF format only. Topics: Knee Prostheses
 
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Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; MedWatch: Food and Drug Administration Medical Products Reporting Program
submitted by healthnews 694 days ago (via edocket.access.gpo.gov)
The FDA is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA).
 
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FDA Public Health Notification: Radiofrequency Ablation of Lung Tumors - Clarification of Regulatory Status
submitted by healthnews 694 days ago (via fda.gov)
This is to clarify the message conveyed in the Public Health Notification entitled Deaths Reported Following Radiofrequency Ablation of Lung Tumors, which was issued on December 11, 2007. It is intended to inform you about the regulatory status of...
 
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Guidance for Industry and FDA Review Staff - Intravascular Administration Sets Premarket Notification Submissions [510(k)]
submitted by healthnews 694 days ago (via fda.gov)
This revision of the document issued in 2005 updates the FDA-recognized standards and clarifies our recommendations for microbial ingress testing.
 
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PMA Final Decisions for August 2008
submitted by healthnews 694 days ago (via fda.gov)
These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for May 2008.
 
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Summary Information for: Akreos™ Posterior Chamber Intraocular Lens
submitted by healthnews 694 days ago (via fda.gov)
PDF format only. Topics: Intraocular Lens (IOL)
 
0 Comments - More Info - Bury   Topic: Medical Device Information