Pre-Submission Request

Pre-Submission Request

This week’s assignment is to write a pre-Submission meeting request to FDA for your medical device (the same one you have been writing about in Discussion Board). You can use the pre-Submission meeting guidance from Week 4 and any other guidance documents you deem important.

The format should follow section 5 of the pre-Submission meeting guidance. The pre-Sub should be for a 510(k) or PMA. If you chose an IVD then you will submit for an IVD 510(k). The pre-Submission meeting request should be at least 5 pages including the table of contents (1 page), the body and any appendices. References should be on a separate page at the end of the document and does not count as one of the 5 pages. A cover page doesn’t count towards the 5 pages either.

the attached document is an example of the assignment

Product name: Azure pacemaker DR MRI Surescan Trade Name: Medtronic Azure pacemaker

The pacemaker medical device is attributed to various standards and guideline documents that determine its functionality. For medical devices, it is crucial to have legitimate standard and guideline documents that guarantee the authenticity of the device as well as the method of use. As such, for the identified pacemaker, there are two standard and two guideline documents that contribute to the effective use of the medical device.

The first standard document, ISO 14117:2019, indicates the various tests carried out to determine the electromagnetic compatibility of the device with the therapy interventions on treating heart problems (ISO, 2019). The document is crucial as it provides the mechanical specifications of the device with an emphasis on its implications on medical interventions for bradycardia and other similar conditions.

The second standard document, 14708-2:2005, highlights the compatibility tests for pacemakers and accessory devices to ensure they function well together. It contains a list of tests required for all pacemakers and accessory products (ISO,2012). The document is important for the medical device as the tests to determine the functionality of the product relative to complementary accessories.

The first guideline document, FDA-2020-D-0957, is a framework of the verification testing in the design of pacemakers to ensure that safe and efficient implantation is possible. The tests are necessary as they guarantee patient safety during and after the implantation of the medical device with no possible risks to their health (FDA, 2018). The document is important as it helps guarantee the safety risks incurred when using the product.

The second guideline document, FDA-2013-S-0610, is an analysis of whether another patient can reuse pacemakers. It indicates that there is no sufficient information that guarantees the success of such an attempt without consequences to the second patient (FDA, 2015). Thus, implanting used pacemakers on another patient is discouraged. The document is essential as it helps prevent unnecessary risks that may occur in such an attempt.