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Other FDA Documents:

June 15, 2009
PMA Final Decisions for May 2009
June 12, 2009
Class I Medical Device Recall: Medtronic Inc., Kappa 600/700/900 Series of Pacemakers and Sigma 100/200/300 Series of Pacemakers
June 11, 2009
FDA News Release: FDA Alerts Patients to Medtronic Pacemaker Recall
See All FDA Other Releases
 
 

Federal Register Notices:

June 9, 2009
Federal Register: Hematology and Pathology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
May 27, 2009
Federal Register: Draft Guidance for Industry on Presenting Risk Information in Prescription Drug and Medical Device Promotion; Availability
May 21, 2009
Federal Register: Temporary Deferment of Activities Relating to Medical Device Submissions
See All FDA Federal Register Notices
 
 

Guidance Documents:

April 16, 2009
Draft Guidance for Industry and FDA Staff: Investigational Device Exemption (IDE) Guidance for Retinal Prostheses
March 30, 2009
Guidance for Industry and FDA Staff: Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products
March 13, 2009
Draft Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Approval Applications
See All FDA Guidance Documents
 
 

FDA Articles

30 Years Later, Preemption Is Still Unsettled
(MD&DI)

Sweeping the House Clean at FDA
(MD&DI)

Is Schultz Under the Democrats' Gun?
(MD&DI)

Congress May Hit Device Makers with a Triple Whammy
(MD&DI)

How Does a Weapon Almost Become a Medical Device?
(MD&DI)

 
 

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