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Info on PMA Approval Sent to OMB

09/17/2007

Federal Register Notice: FDA has submitted a proposed collection of information, “Premarket Approval of Medical Devices &mda...

Comments Reopened on IVD Assay Guidance

09/17/2007

Federal Register Notice: FDA is reopening until 10/17, the comment period for Draft Guidance for Industry, Clinical Laboratories, ...

Guidance on Decorative/Non-corrective Contacts

11/27/2006

Federal Register Notice: FDA is making available a document entitled Guidance for Industry, FDA Staff, Eye Care Professionals, an...

Dispute Panel to Discuss Acorn Device

11/27/2006

Federal Register Notice: FDA’s Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee will meet...

Comments Sought on E-submissions to CVM

11/08/2006

Federal Register Notice: FDA is seeking comments on extending Office of Management and Budget (OMB) approval on the existing repo...

Comments Sought on E-mailing a Study Protocol

11/08/2006

Federal Register Notice: FDA is seeking public comment on extending OMB approval of existing reporting requirements for the infor...

Comments Sought on Electronic Meetings Requests with CVM

11/08/2006

Federal Register Notice: FDA is seeking comments on extending Office of Management and Budget (OMB) approval of existing reportin...

FDA Submits Info on Device Inspections to OMB

11/03/2006

Federal Register Notice: FDA’s proposed collection of information, "Medical Devices: Inspection by Accredited Persons Progr...

FDA Publishes Modifications to Recognized Standards

11/03/2006

Federal Register Notice: FDA is releasing a publication containing modifications it is making to the list of standards the agency...

Comments Sought on Premarket Notification

11/03/2006

Federal Register Notice: FDA is seeking comment on the proposed collection of certain information, "Premarket Notification &mdash...