2016 was a busy year for everyone, especially for the FDA. Last year, the FDA passed several guidance documents and drafts relating to digital health. They also cleared a huge number of devices and had notable conversations with vendors throughout the year. The FDA even turned down certain devices that were considered certain to be cleared in 2016. A lot can change in a year in digital health.
A Year for Guidance
The FDA spends a lot of time clearing new devices for publication. In June 2016, the FDA brought out a draft guidance that is designed for companies to help with FDA 510k. The guidance that was published was also brought out to help makers of medical devices understand how the FDA thinks about the patients and their access. It is a hot issue to talk about, but patient advocacy and the rights of patients allowed to access their own medical data is an important one.
According to an article by Healthcare IT News, technology evolvement is powering patient access, access to care, and access to new ideas. The connections that can be discovered with patients via smartphone, messaging and video offers an infrastructure to remotely monitor patients. Digital health and platforms pointing to analytics allow the medical devices in the home to remotely identify and help health issues. Healthcare can move forward with the ability to capture the data of real-time patients, which will put medical help light years ahead. People looking for companies to help with the FDA 510k process are going to be better off as the FDA are clearing devices better than ever.
Not Cleared
The FDA is more than just a rubber stamp on innovation and new devices, and this is proven by the fact that there are still several medical devices that have yet to be cleared. In 2016, the FDA refused the approval of what could have been the first drug on the mass market that included an ingestible sensor. Companies such as http://www.fdathirdpartyreview.com/ are there to help those looking for FDA approval and walk them through the process to hopefully avoid being declined.
Digital healthcare services are continually evolving, and like most things that relate to the federal government, the FDA’s future is still unclear right now despite a general assumption that incoming President Trump might relax FDA regulations.