The Food and Drug Administration’s eSubmitter tool is part of an electronic submissions program that originated in the Center for Devices and Radiological Health (CDRH).

FDA eSubmitter is an improved and expanded package for a variety of submission types and is now available for voluntary use by the sponsors and manufacturers in the device and Radiological Health and blood regulated industries.

eSubmitter is free software intended to allow sponsors to:

• electronically complete and submit premarket notification applications [510(k)] to the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
• electronically complete and submit information for a variety of radiation safety Product Reports and Annual Reports for radiation emitting products to the Radiological Health Program
• electronically complete and submit the Medwatch 3500A form for medical device adverse event reports
• electronically complete and submit form 2579 for Report of Assembly of a Diagnostic X-Ray Systems
• electronically submit blood related BLA’s as an approved participant in the FDA eSubmitter pilot evaluation program for the Office of Blood Research and Review (OBRR) within the Center for Biologics Evaluation and Research (CBER). See more information on becoming a pilot participant for CBER.

Download Software

To download the FDA eSubmitter software, click on the following link.

Way to Install

Save the installation zip file to your computer and extract the jinstall.exe file. Double-click the jinstall.exe file to run the installation. Follow the instructions provided in the installation wizard.

1. Download eSubmitter Software

2. Download User Manual (Updated June 2009)

3. Download Quick Guide (Updated June 2009)

FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States.

CDRH also regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions.

Medical devices are classified into Class I, II, and III. Regulatory control increases from Class I to Class III.

1. Class I devices are exempt from Premarket Notification 510(k)
2. Class II devices require Premarket Notification 510(k)
3. Class III devices require Premarket Approval.

Source: FDA

According to 21 CFR 1000-1040.11, each laser therapy machine must adhere to a strict policy and regulations standard (Mandatory Performance Standard) and other Federal laser product performance and CDRH Office of Compliance standards before they may be cleared for use. In addition, only licensed professionals may use laser therapy machines, so always be sure to check with the therapist for permission to use the machine on humans before allowing a procedure to be performed.

In addition to machine clearance, the FDA also requires that any laser therapy centers offering stop smoking aid or weight loss therapy provide an IRB (Investigational Review Board) service. It is vital that patients who are told that a specific laser therapy center need not follow this rule find an alternate location for their procedure, as this law is critical and non-compliance could mean that a laser therapy center is closed down permanently. This rule is due to the fact that no laser therapy machine has been cleared by the FDA specifically for use as a stop smoking aid or weight loss aid.

The CDRH Sexuality Symposium went well. I’d say we had 30-40 people in attendance. Videos follow.

Intro – Mark Robinson

http://video.google.ca/videoplay?docid=4589836264859033213&hl=en-CA

Changing Gender Roles – Terry Price (me)

http://video.google.ca/videoplay?docid=-1917650878329946192&hl=en-CA

Animal Sexuality – Mark Robinson

http://video.google.ca/videoplay?docid=-7519262397743175130&hl=en-CA

Psychology of Religious and Sexual Conflicts: Part1 – Dr. Khalid Sohail

http://video.google.ca/videoplay?docid=-8547988086342854982&hl=en-CA

Psychology of Religious and Sexual Conflicts: Part 2 – Dr. Khalid Sohail

http://video.google.ca/videoplay?docid=9120101453366190122&hl=en-CA

And, of course more info can be found at cdrh.humanists.ca