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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

31

Mar

FDA CBER 1994 BECS Manufacturer Letter

March 31, 1994Alan KusinitzNews

/docs/CBER-BECS510kLetter1994.pdf

01

Oct

Inhalers, Spacers FDA CDRH 510(k) Nebulizers

October 1, 1993Alan KusinitzNews

http://www.fda.gov/cdrh/ode/784.html

28

Sep

Guideline for Val of Blood Establishment Computers

September 28, 1993Alan KusinitzNews

http://www.fda.gov/cber/gdlns/bldestcomp.htm

01

Aug

FDA CDRH 510(k) Guidance for PACS – OBSOLETE

August 1, 1993Alan KusinitzNews

/docs/PACSguidance.pdf

01

Mar

FDA CDRH 510(k) External Infusion Pumps

March 1, 1993Alan KusinitzNews

http://www.fda.gov/cdrh/ode/odegr823.html

01

May

FDA Device GMP Guidance: Computerized Devices

May 1, 1992Alan KusinitzNews

/docs/fdagmpcomputerinspectionguide1992.pdf

04

Sep

I/O Checks FDA CDER/ORA CPG 7132a.07 Monitoring

September 4, 1987Alan KusinitzNews

/Docs/7132a-425-400.PDF

04

Sep

FDA CDER/ORA CPG 7132a.11 Software as Records

September 4, 1987Alan KusinitzNews

/Docs/7132a-425-100.pdf

04

Sep

FDA CDER/ORA CPG 7132a.12 Vendor Responsibility

September 4, 1987Alan KusinitzNews

/Docs/7132a-425-200.PDF

01

Jul

FDA Technical Reference on Software Development

July 1, 1987Alan KusinitzNews

/docs/fdaswtechnicalreference1987.pdf

16

Apr

FDA CDER/ORA CPG 7132a.08 Computerized ID

April 16, 1987Alan KusinitzNews

/Docs/7132a-425-500.PDF

16

Apr

FDA CDER/ORA CPG 7132a.15 Source Code

April 16, 1987Alan KusinitzNews

/Docs/7132a-425-300.PDF

01

Feb

FDA CDER Inspection of Computer Systems

February 1, 1983Alan KusinitzNews

/Docs/FDAdrugswguidanceFeb1983.pdf

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