When is a 2579 required

Let me answer the questions I get most often so that you can have the documentation you need, when you need it. Under the Department of Health and Human Services, the FDA requires that any time a piece of X-ray emitting medical imaging equipment is installed an FDA form is filled out by the installing engineer or assembler.

Essentially, by filling out the form the installer is saying they installed the device per manufacturer instructions. Please note that the need for a is not limited to the installation of a complete system. There are a number of components which, if installed on a separate occasion such as a repair or a field upgrade, will also need to have a filed.

To see which parts fall in this category, click the linked sample image above or the download button at the end and refer to section 4.

Federal Acquisition Regulatory Council. My Favorites. Training Acquisition Systems. FAR 4. Enter the contract or order modification number or solicitation amendment number. Enter the appropriate information in Blocks 6a through 6e. Enter description of planned acquisition, including quantity, unique delivery requirements, and other descriptors.

Enter the estimated beginning and end dates. Check all that apply, e. For Blocks 10c through 10d, attach justification if applicable in accordance with FAR However, every acquisition between these two thresholds is automatically set aside anyways for small business…so why bother? The Small Business Office in your organization uses the DD as a tracking document for the agencies yearly small business goals.

So whether or not the acquisition is set aside or not they use that information in their yearly goals. As far as local policy, I would ask your policy shop and your small business office to what is required. Effective August 31, Please note that you should expect to receive a response from our team, regarding your inquiry, within 2 business days.