Skip to : [Content] [Navigation]
 

FDA Zone

 
 

Other FDA Documents:

July 7, 2008
510(k) Final Decisions - June 2008
July 7, 2008
Gastroenterology and Urology Devices Panel Advisory Meeting, June 25, 2008 - Agenda, Draft Roster, Final Roster, Briefing, Questions
July 2, 2008
FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Performance Assessment - Guidance for Industry and FDA Staff
See All FDA Other Releases
 
 

Federal Register Notices:

June 27, 2008
Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Good Laboratory Practice Regulations for Nonclinical Studies
June 27, 2008
Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Labeling Regulations
June 26, 2008
Federal Register: Hematology and Pathology Devices Panel fo the Medical Devices Advisory Committee; Notice of Meeting
See All FDA Federal Register Notices
 
 

Guidance Documents:

May 29, 2008
Draft Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters
May 29, 2008
Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Full Field Digital Mammography System
May 29, 2008
Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin
See All FDA Guidance Documents
 
 

FDA Articles

Republicans Press FDA on Device Appeals
(MD&DI)

Assessing FDA Regulation of Diagnostic Tests and Services
(MD&DI)

FDA Placing Its Own Personnel in China
(MD&DI)

FDA Omits an Inconvenient Truth
(MD&DI)

Do FDA Chiefs Have Real Power?
(MD&DI)

 
 

FDA Quick Links

Current FDA Warning Letter Database

Archived FDA Warning Letter Database

Releasable 510(k)s

Releasable PMAs

Releasable Establishment Registrations

Releasable Device Listings

Good Guidance Practices

More CDRH databases

 
 

CDRH Resources

FDA Home Page

FDA's Center for Devices and Radiological Health

Device Advice

CDRH Topic Index

The Code of Federal Regulations