FDA / EU / Regulatory Updates
This draft guidance describes the technical standards associated with preparation of the electronic submission template for 510(k)s that, when the guidance is finalized, will enable submission of the 510(k)s solely in electronic format. The electronic submission template includes the information and guided prompts FDA believes will best facilitate the collection and assembly of the necessary elements of a ‘complete’ submission, as required by regulation or essential to FDA’s substantive review of the 510(k) submission.
The electronic submission template, eSTAR, is the only currently available electronic submission template at this time to facilitate the preparation of 510(k) electronic submissions. eSTAR consists of a collection of questions, text, logic, and prompts within a template that guides a user through construction of a ‘complete’ 510(k) submission. eSTAR is highly automated, includes integrated databases (e.g., FDA product codes, FDA-recognized voluntary consensus standards), and includes targeted questions designed to collect specific data and information from the submitter.
Upon finalization of this draft guidance, electronic submissions for all 510(k)s and subsequent submissions to an original submission, including amendments (amendments include add-to-files and appeals) and supplements are required to be submitted as electronic submissions.
Over the past decade, the FDA has reviewed and authorized a growing number of devices legally marketed (via 510(k) clearance, granted De Novo request, or approved PMA) with ML across many different fields of medicine—and expects this trend to continue.
The FDA is providing this initial list of AI/ML-enabled medical devices legally marketed in the United States as a resource to the public about these devices and the FDA’s work in this area. One of the greatest potential benefits of ML resides in its ability to create new and important insights from the vast amount of data generated during the delivery of health care every day.
There are 343 devices recorded in this initial list and the FDA plans to update this list on a periodic basis based on publicly available information.
Cybersecurity
On May 7, 2021 HealthReach Community Health Centers in Maine was notified that hard drives containing information belonging to HealthReach Community Health Centers’ patients and employees were improperly disposed of by an employee at a third-party data storage facility.
Based on the results of an investigation conducted by third-party forensic vendors, HealthReach Community Health Centers determined that the following elements of personal information may potentially be accessed and/or acquired by an unauthorized individual: names, addresses, dates of birth, social security numbers, medical record number, medical insurance information, lab results, treatment records and financial account information. The exact elements of personal information that may have be exposed as a result of this incident varies per individual.
