DA's recent draft guidance Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types, enables innovation of medical devices by decoupling what has historically been handled within the PMA track, often as Supplements.
Historically, some parent devices have had hundreds of supplements over time, some of which have included "accessories" which supplement and augment the parent device. This required the parent device company to either develop the "accessory" or collaborate with innovators to allow for the submission of the supplements. It also required the submissions to be evaluated with Class III requirements.
This limited innovators with fresh ideas to formal arrangements and the costs associated with a Class III evaluation.
With the new draft guidance, accessories are de-coupled from the parent device, and can be submitted independently, simply referencing the parent device. The De Novo path, further lowers the threshold to low-medium risk level requirements and the time to clearance is reduced to a 120 day process.
What this guidance does is foster health care innovation. By allowing innovators to identify workflow issues or medical needs for sub-population and to develop "accessories" to current devices, health care innovation can be fast tracked and patient access to medical devices expanded (just as the balloon catheter supplements mentioned in the draft guidance).
With convergence of health information technology, advances in scientific discovery and desire for personalized medicine, this guidance, if finalized, could allow innovators to submit accessory devices to existing products that bring innovation to the practice of medicine.
Challenges that innovators will face will be less the FDA but more the evidence for reimbursement, as I mentioned in my previous blog “Reimbursement is the elephant in the room, not FDA or CE Mark”. Generally speaking the De Novo process will not require clinical trials, yet reimbursement coverage often requires evidentiary information in the form of clinical trials published in peer review journals.
ClearRoadmap can then be used to quickly identify past "accessories" that were submitted as Supplements or 510ks and their clinical trials.
We developed ClearRoadmap (https://clearroadmap.com) using in-context Natural Language Processing for a single search interface across all datasets: 510k, DeNovo, PMA (SSED), Supplements, Predicates, Standards and Guidance, Recalls, Warning issuances, Clinical Trials.gov and CMS Reimbursement. This allows you breadth across datasets and depth into the details. Because it matters if you are looking for device description or adverse events. ClearRoadmap is built to know the difference.
Now you can find medical device and mHealth information in seconds and minutes what traditionally takes hours and days.
ClearRoadmap is a new standard to search for medical device and mHealth information.
-- Vizma Carver, Founder and CEO
Carver Global Health Group LLC| email@example.com