RAM BALANI
CEO, FDASmart Inc., USA

Abstract

Article discusses the new US FDA official eSTAR PDF Template for medical devices 510(k) submissions to assist with  generating more timely and efficient device substantial equivalence data assembly, construction and validations.

A brief overview of the medical device 510(K) submission and review process by the US FDA is covered including various medical devices classes, requirements to meet device substantial equivalence to an existing predicate device.

The article introduces how eSTAR integrates into Microsoft TEAMs environment very relevant in today’s new normal, virtual global workforce and illustrates how Microsoft TEAMs out-of-the-box (OOTB) & advanced features can ‘embrace & extend’ the eSTAR template for optimal remote working, eSTAR pages channel collaboration, approval request/processing with alerts and notification when files are uploaded into TEAMs.

There’s a new “sheriff” in town, as the saying goes, and he’s got a badge- this one is the US FDA with eSTAR! The territory includes in-vitro (nIVD) and non-invitro (IVD) 510(K) medical devices premarket notifications, their subsequent processing by the US FDA and approval of 510(K) device clearances for US markets!

What is eSTAR?

US FDA’s eSTAR stands for “Electronic Submissions Template and Resource”, i.e. in plain English – an interactive PDF form-filling enabled, Adobe XFA digitally secure designed architecture and rich feature-set PDF template which in one case is just like any other Adobe PDF standard document but in many ways, very different indeed.

For instance, one can open up eSTAR PDF file with either Adobe Acrobat DC or Adobe Acrobat Pro, view the eSTAR twenty-one (21 total) pages thumbnails and fill in form fields and save data entered to a .PDF file. See Figure 1-eSTAR Home Screen.

How is it different? One can’t edit the actual eSTAR template form text and can only highlight or make comments after ‘printing’ the eSTAR template, not to a printer, but to a file. ...