Over the past year there have been a series of draft letters from the FDA on the approval process for medical devices, particularly in the arena of digital health. After several years of being a hyper-vigilant regulatory agency and effectively slowing down the approval process for new products, the FDA has begun to relax its approval requirements, especially for digital health products.
Historically, the FDA has divided medical devices according to device classification and risk to patient and user. Class I includes devices with the lowest risk such as an activity tracker like a Shine or Fitbit and Class III includes those with the greatest risk such as pacemakers or implants.
The class indicates what level of premarket approval is necessary. Most Class I and Class II devices are exempt from the 510(k) Premarket Notification application. Most Class III devices require full Premarket Approval (PMA), which generally requires clinical data to support claims.
With the influx of new digital devices, the FDA has been wrestling with how to balance encouragement of innovation with its mandate to protect the general public. Recently, the FDA has begun using “enforcement discretion” more frequently in the approval process. This allows administrative-level discretion as to whether or not a new digital or diagnostic device needs to go through the 510(k) application process. If a company is able to demonstrate that the new device poses very low risk to a patient, the device may not need to go through the process at all.
Specifically, “the FDA does not intend to enforce compliance with the regulatory controls that apply to MDDS (Medical Device Data Systems) devices, medical image storage devices, and medical image communications devices.”
Basically, the FDA is saying it is no longer in the business of monitoring or tracking no- or low-risk digital health products. By exempting these products from 510(k) premarket notification, these devices would effectively be completely unregulated. This shift has lifted a tremendous burden from tech entrepreneurs and companies like Apple, among others, and it opens the door for new opportunities, companies and investors.
In terms of innovation, this change is going to empower many tech entrepreneurs to invest in the digital health device market. Companies that previously avoided the risks of the healthcare regulatory environment now have the opportunity to get a foot in the game without having to deal with harsh FDA regulations.
As a result of these changes in the FDA approval process, companies may find opportunities to get involved earlier in the innovation stages of product development. This could usher in a new era of creativity and tech experimentation, with a positive impact on consumers and the healthcare industry alike.