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FDA Withdraws Proposed Rule on Shortwave Diathermy Devices

02/20/2014

Federal Register Proposed rule: FDA is withdrawing a 7/6/12 proposed rule that would require the filing of a PMA or a notice of co...

FDA Proposes to Reclassify Shortwave Diathermy

02/20/2014

Federal Register Proposed order: FDA is proposing to reclassify the shortwave diathermy (SWD) for all other uses, a preamendments ...

FDA Revises/Corrects MDR Reg

02/14/2014

Federal Register Final rule: FDA is revising its postmarket medical device reporting regulation and making technical corrections. ...

Guidance on Electronic Medical Device Reporting

02/14/2014

Federal Register Notice: FDA is making available a guidance, Questions and Answers About eMDR — Electronic Medical Device Re...

FDA Stem Cell Case is 'Far Reaching'

02/06/2014

An appeals court decision earlier this week against Regenerative Sciences ( ("http://www.fdaweb.com/login.php?sa=v&aid=D5127613&se...

Panel to Discuss 2014-15 Flu vaccine

01/31/2014

Federal Register Notice: FDA’s Vaccines and Related Biological Products Advisory Committee will meet 2/28, from about 8 a.m....

FDA Updates List of Device Recognized Standards

01/30/2014

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

Info on Device Fellowship Program Sent to OMB

01/23/2014

Federal Register Notice: FDA has submitted a proposed collection of information, “Application for Participation in the Medic...

OMB Approves Info on IND Reporting, Bioavailability, Bioequivalence

01/23/2014

Federal Register Notice: FDA’s collection of information entitled “Investigational New Drug Safety Reporting Requireme...

Public Docket will Receive Input on Improving ANDAs

01/23/2014