fda Archives

Jul

FDA CDRH 510(k) Underwater Exercise Equipment

July 26, 1995Alan KusinitzNews

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

Jul

FDA CDRH 510(k) Immersion Hydrobaths

July 26, 1995Alan KusinitzNews

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

Jul

FDA CDRH 510(k) Wheelchairs

July 26, 1995Alan KusinitzNews

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

Jul

FDA guideline for QA in blood establishments

July 11, 1995Alan KusinitzNews

/Docs/cberbloodestablishmentQAguideline.pdf

Jul

FDA CDRH Draft Ventilator 510(k) Guidance

July 1, 1995Alan KusinitzNews

/docs/Ventilator510kdraftguidance1995.pdf

Feb

FDA Intel Pentium Problem Letter

February 14, 1995Alan KusinitzNews

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

Aug

FDA CDRH 510(k) Biofeedback Devices

August 1, 1994Alan KusinitzNews

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

Aug

FDA CDRH 510(k) Galvanic Skin Response

August 1, 1994Alan KusinitzNews

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

Aug

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

August 1, 1994Alan KusinitzNews

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

Jul

FDA CDRH 510(k) Draft Version Neuro Endoscope

July 7, 1994Alan KusinitzNews

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

Mar

FDA CBER 1994 BECS Manufacturer Letter

March 31, 1994Alan KusinitzNews

/docs/CBER-BECS510kLetter1994.pdf

Oct

Inhalers, Spacers FDA CDRH 510(k) Nebulizers

October 1, 1993Alan KusinitzNews

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

Sep

Guideline for Val of Blood Establishment Computers

September 28, 1993Alan KusinitzNews

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

Aug

FDA CDRH 510(k) Guidance for PACS – OBSOLETE

August 1, 1993Alan KusinitzNews

/docs/PACSguidance.pdf

Mar

FDA CDRH 510(k) External Infusion Pumps

March 1, 1993Alan KusinitzNews

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

May

FDA Device GMP Guidance: Computerized Devices

May 1, 1992Alan KusinitzNews

/docs/fdagmpcomputerinspectionguide1992.pdf

Sep

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

September 4, 1987Alan KusinitzNews

/Docs/7132a-425-400.PDF

Sep

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

September 4, 1987Alan KusinitzNews

/Docs/7132a-425-100.pdf

Sep

FDA CDER/ORA CPG 7132a.12 Vendor Responsibility

September 4, 1987Alan KusinitzNews

/Docs/7132a-425-200.PDF

Jul

FDA Technical Reference on Software Development

July 1, 1987Alan KusinitzNews

/docs/fdaswtechnicalreference1987.pdf

Apr

FDA CDER/ORA CPG 7132a.08 Computerized ID

April 16, 1987Alan KusinitzNews

/Docs/7132a-425-500.PDF

Apr

FDA CDER/ORA CPG 7132a.15 Source Code

April 16, 1987Alan KusinitzNews

/Docs/7132a-425-300.PDF

Feb

FDA CDER Inspection of Computer Systems

February 1, 1983Alan KusinitzNews

/Docs/FDAdrugswguidanceFeb1983.pdf

1 … 18 19 20

FDA CDRH 510(k) Underwater Exercise Equipment

FDA CDRH 510(k) Immersion Hydrobaths

FDA CDRH 510(k) Wheelchairs

FDA guideline for QA in blood establishments

FDA CDRH Draft Ventilator 510(k) Guidance

FDA Intel Pentium Problem Letter

FDA CDRH 510(k) Biofeedback Devices

FDA CDRH 510(k) Galvanic Skin Response

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

FDA CDRH 510(k) Draft Version Neuro Endoscope

FDA CBER 1994 BECS Manufacturer Letter

Inhalers, Spacers FDA CDRH 510(k) Nebulizers

Guideline for Val of Blood Establishment Computers

FDA CDRH 510(k) Guidance for PACS – OBSOLETE

FDA CDRH 510(k) External Infusion Pumps

FDA Device GMP Guidance: Computerized Devices

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

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

FDA CDER/ORA CPG 7132a.12 Vendor Responsibility

FDA Technical Reference on Software Development

FDA CDER/ORA CPG 7132a.08 Computerized ID

FDA CDER/ORA CPG 7132a.15 Source Code

FDA CDER Inspection of Computer Systems

Upcoming Public Courses

Corporate Office

Tag

Upcoming Public Courses

Corporate Office