fda Archives

FDA CDRH Office of Device Evaluation standards recognition statement for ” IEC 60601-1-4:1996, Medical electrical equipment – Part 1: General requirements For safety; 4. Collateral Standard: Programmable electrical medical systems”. FDA did not choose to recognize this standard for software submissions or even outright for risk management. They did issue a recognition statement explaining their...

Aug

FDA CDRH Hemodialysis Delivery 510(k) Guidance

August 4, 1998Alan KusinitzNews

/docs/HEMODIALYSISDELIVERYSYSTEMS.pdf

Aug

FDA CDRH Washer/Disinfector 510(k) Draft Guidance

August 4, 1998Alan KusinitzNews

/docs/washerdisinfectors1998draft.pdf

Jul

FDA CDRH 510(k) Sodium Test System

July 6, 1998Alan KusinitzNews

http://www.fda.gov/cdrh/ode/75.html

Jul

FDA CDRH 510(k) Urea Nitrogen Test System

July 6, 1998Alan KusinitzNews

http://www.fda.gov/cdrh/ode/72.html

Jul

FDA CDRH 510(k) Chloride Test System

July 6, 1998Alan KusinitzNews

http://www.fda.gov/cdrh/ode/73.html

Jul

FDA CDRH 510(k) Potassium Test System

July 6, 1998Alan KusinitzNews

http://www.fda.gov/cdrh/ode/77.html

Jul

FDA CDRH 510(k) Creatinine Test System

July 2, 1998Alan KusinitzNews

http://www.fda.gov/cdrh/ode/74.html

Jun

FDA CBER: BECS & Submission types

June 11, 1998Alan KusinitzNews

/Docs/CBERnew510kparadigmslides4perpage.pdf

Jun

FDA DSMA Software Display/Labeling

June 8, 1998Alan KusinitzNews

http://www.fda.gov/cdrh/devadvice/

May

Obsolete FDA CDRH ODE Software Submission Guidance

May 29, 1998Alan KusinitzNews

/docs/FDASoftwareSubmissionGuidance052898obsolete.pdf

Apr

FDA Image Management Classification Rule

April 29, 1998Alan KusinitzNews

/docs/PACsclassification.pdf

Mar

FDA CDRH 510(k) New Paradigm Guidance

March 20, 1998Alan KusinitzNews

/docs/510knewparadigmguidance.pdf

Mar

FDA CDRH 510(k) Bone Growth Stimulator Device

March 18, 1998Alan KusinitzNews

http://www.fda.gov/cdrh/ode/bgsguide.pdf

Feb

FDA CDRH 510(k)PMA supplements for process change

February 19, 1998Alan KusinitzNews

http://www.fda.gov/cdrh/modact/daypmasp.pdf

Jan

FDA CDRH ODE PMA Manual Software Excerpts

January 1, 1998Alan KusinitzNews

http://www.fda.gov/cdrh/manual/pmamanul.pdf

Nov

FDA CDRH 510(k) Electrocencephalograph Devices

November 3, 1997Alan KusinitzNews

http://www.fda.gov/cdrh/ode/eedev.html

Jun

FDA CDRH 510(k) Intrapartum Continuous Monitors

June 4, 1997Alan KusinitzNews

http://www.fda.gov/cdrh/ode/fetal.html

May

FDA CDRH QSr Design Control Guidance-obsolete

May 11, 1997Alan KusinitzNews

/Docs/designcontrolguidance.pdf

May

FDA 21 CFR 806 Corrections and Removals

May 9, 1997Alan KusinitzNews

/docs/FDACorrections-removals.pdf

Mar

21 CFR Part 11, March 1997

March 20, 1997Alan KusinitzNews

/Docs/esignatureswithpreamble.pdf

Mar

FDA CDRH ODE NIBP Guidance

March 10, 1997Alan KusinitzNews

http://www.fda.gov/cdrh/ode/noninvas.html

Feb

FDA CDRH ODE Portable Glucose Monitor Guidance

February 28, 1997Alan KusinitzNews

/Docs/PortableGlucoseSubmissionGuidance.htm

Jan

FDA CDRH 510(k) Vitreous Aspiration

January 31, 1997Alan KusinitzNews

http://www.fda.gov/cdrh/ode/83.html

Jan

Obsolete FDA Blood Bank 510(k) reviewers guidance

January 13, 1997Alan KusinitzNews

/Docs/Bloodbank510kguidance.pdf

Jan

1997 FDA CDRH 510(k) Device Modifications

January 10, 1997Alan KusinitzNews

/docs/510kmod.pdf

Dec

FDA DSMA Quality System Manual

December 15, 1996Alan KusinitzNews

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/MedicalDeviceQualitySystemsManual/default.htm

Dec