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fda

06

Jul

FDA CDRH 510(k) Urea Nitrogen Test System

July 6, 1998Alan KusinitzNews

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

02

Jul

FDA CDRH 510(k) Creatinine Test System

July 2, 1998Alan KusinitzNews

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

11

Jun

FDA CBER: BECS & Submission types

June 11, 1998Alan KusinitzNews

/Docs/CBERnew510kparadigmslides4perpage.pdf

08

Jun

FDA DSMA Software Display/Labeling

June 8, 1998Alan KusinitzNews

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

29

May

Obsolete FDA CDRH ODE Software Submission Guidance

May 29, 1998Alan KusinitzNews

/docs/FDASoftwareSubmissionGuidance052898obsolete.pdf

29

Apr

FDA Image Management Classification Rule

April 29, 1998Alan KusinitzNews

/docs/PACsclassification.pdf

20

Mar

FDA CDRH 510(k) New Paradigm Guidance

March 20, 1998Alan KusinitzNews

/docs/510knewparadigmguidance.pdf

18

Mar

FDA CDRH 510(k) Bone Growth Stimulator Device

March 18, 1998Alan KusinitzNews

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

19

Feb

FDA CDRH 510(k)PMA supplements for process change

February 19, 1998Alan KusinitzNews

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

01

Jan

FDA CDRH ODE PMA Manual Software Excerpts

January 1, 1998Alan KusinitzNews

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

03

Nov

FDA CDRH 510(k) Electrocencephalograph Devices

November 3, 1997Alan KusinitzNews

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

04

Jun

FDA CDRH 510(k) Intrapartum Continuous Monitors

June 4, 1997Alan KusinitzNews

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

11

May

FDA CDRH QSr Design Control Guidance-obsolete

May 11, 1997Alan KusinitzNews

/Docs/designcontrolguidance.pdf

09

May

FDA 21 CFR 806 Corrections and Removals

May 9, 1997Alan KusinitzNews

/docs/FDACorrections-removals.pdf

20

Mar

21 CFR Part 11, March 1997

March 20, 1997Alan KusinitzNews

/Docs/esignatureswithpreamble.pdf

10

Mar

FDA CDRH ODE NIBP Guidance

March 10, 1997Alan KusinitzNews

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

28

Feb

FDA CDRH ODE Portable Glucose Monitor Guidance

February 28, 1997Alan KusinitzNews

/Docs/PortableGlucoseSubmissionGuidance.htm

31

Jan

FDA CDRH 510(k) Vitreous Aspiration

January 31, 1997Alan KusinitzNews

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

13

Jan

Obsolete FDA Blood Bank 510(k) reviewers guidance

January 13, 1997Alan KusinitzNews

/Docs/Bloodbank510kguidance.pdf

10

Jan

1997 FDA CDRH 510(k) Device Modifications

January 10, 1997Alan KusinitzNews

/docs/510kmod.pdf

15

Dec

FDA DSMA Quality System Manual

December 15, 1996Alan KusinitzNews

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

15

Dec

FDA DSMA Quality System Manual Chapter 7

December 15, 1996Alan KusinitzNews

/docs/DSMAQSmanualChapter7-Dec96.pdf

01

Dec

FDA CDRH Human Factors Do It By Design

December 1, 1996Alan KusinitzNews

/docs/doitbydesign.pdf

07

Oct

FDA CDRH 21 CFR 820 QS reg without the preamble

October 7, 1996Alan KusinitzNews

/Docs/qsregwithoutpreamble.pdf

07

Oct

FDA CDRH 21 CFR 820 Quality System Regulation

October 7, 1996Alan KusinitzNews

/Docs/qsregwithpreamble.pdf

06

Sep

FDA CDRH 510(k) Non-Stress Tests Letter to Manuf.

September 6, 1996Alan KusinitzNews

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

03

Sep

FDA CDRH Software Policy Workshop

September 3, 1996Alan KusinitzNews

http://www.fda.gov/cdrh/ost/nuswpolc.html

11

Jul

FDA CDRH Telemedicine Update

July 11, 1996Alan KusinitzNews

/Docs/telemedupdate.pdf

26

Jun

FDA CDRH CADx Workshop Summary

June 26, 1996Alan KusinitzNews

/docs/cadx.txt

19

Jun

FDA CDRH Defibrillator Draft 510(k) Guidance

June 19, 1996Alan KusinitzNews

FDA CDRH Office of Device Evaluation’s “Draft Guidance for Implantable Cardioverter-Defibrillators Version 4.2” June 19, 1994. Section II.B addresses this so for documentation requirements for 510(k) submissions for this type of medical device by simply referring to the general software submission guidance and the Off-the-shelf software Submission guidance. Earlier versions of this draft at additional...

10

Jun

FDA CDRH 510(k) Automated Analyzers

June 10, 1996Alan KusinitzNews

http://www.fda.gov/cdrh/ode/odecl950.html

01

May

E6 Good Clinical Practice

May 1, 1996Alan KusinitzNews

/Docs/ICH-GCPs959fnl.pdf

14

Mar

FDA CDRH 510(k) Thermal Endometrial Ablation

March 14, 1996Alan KusinitzNews

http://www.fda.gov/cdrh/ode/507.html

07

Mar

FDA CDRH 510(k) Hysteroscopes and Laparoscopes

March 7, 1996Alan KusinitzNews

http://www.fda.gov/cdrh/ode/907.html

21

Nov

FDA CDRH 510(k) Reqs for Firms Initiating Recalls

November 21, 1995Alan KusinitzNews

/docs/FDA510krequirementsforrecallsBlueBookMemoK95-1.pdf

21

Nov

FDA CDRH 510(k) Requirements During Recalls

November 21, 1995Alan KusinitzNews

/docs/510(k)reqs4recallfixes.PDF

01

Aug

FDA ORA Software Glossary

August 1, 1995Alan KusinitzNews

/docs/fdaswglossary.pdf

01

Aug

ISO/IEC 12207

August 1, 1995Alan KusinitzNews

“Information Technology – Software Lifecycle Processes” and issued August 1995. This document was the basis for development of the AAMI Medical Device Software Development Standard and was one of the first software standards recognized by FDA for submission purposes. It can be ordered directly from the IEC at www.iec.ch. Just go to their web store...

26

Jul

FDA CDRH 510(k) Communication/Control Systems

July 26, 1995Alan KusinitzNews

http://www.fda.gov/cdrh/ode/762.html

26

Jul

FDA CDRH 510(k) Powered Tables and PT Tables

July 26, 1995Alan KusinitzNews

http://www.fda.gov/cdrh/ode/735.html

26

Jul

FDA CDRH 510(k) Underwater Exercise Equipment

July 26, 1995Alan KusinitzNews

http://www.fda.gov/cdrh/ode/307.pdf

26

Jul

FDA CDRH 510(k) Immersion Hydrobaths

July 26, 1995Alan KusinitzNews

http://www.fda.gov/cdrh/ode/729.pdf

26

Jul

FDA CDRH 510(k) Wheelchairs

July 26, 1995Alan KusinitzNews

http://www.fda.gov/cdrh/ode/346.pdf

11

Jul

FDA guideline for QA in blood establishments

July 11, 1995Alan KusinitzNews

/Docs/cberbloodestablishmentQAguideline.pdf

01

Jul

FDA CDRH Draft Ventilator 510(k) Guidance

July 1, 1995Alan KusinitzNews

/docs/Ventilator510kdraftguidance1995.pdf

14

Feb

FDA Intel Pentium Problem Letter

February 14, 1995Alan KusinitzNews

http://www.fda.gov/cdrh/comp/guidance/fod456.pdf

01

Aug

FDA CDRH 510(k) Biofeedback Devices

August 1, 1994Alan KusinitzNews

http://www.fda.gov/cdrh/ode/143.html

01

Aug

FDA CDRH 510(k) Galvanic Skin Response

August 1, 1994Alan KusinitzNews

http://www.fda.gov/cdrh/ode/215.html

01

Aug

FDA CDRH 510(k) Guidance for Tens 510(k) Content

August 1, 1994Alan KusinitzNews

http://www.fda.gov/cdrh/ode/300.pdf

07

Jul

FDA CDRH 510(k) Draft Version Neuro Endoscope

July 7, 1994Alan KusinitzNews

http://www.fda.gov/cdrh/ode/214.html

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SoftwareCPR Training Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software

ISO 14971 Risk Management (typically with heavy emphasis on software aspect)

IEC 81001-5-1 Cybersecurity Lifecycle

ISO 13485 QMS Requirements & optionally ISO 19011 for leading audits

Being Agile Yet Compliant (AAMI TIR 45)

IEC 29119-1 Software and System Testing

US Classification for Software Devices

IEC 62366 Usability Process and Documentation

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