Over the past couple of years, FDA has introduced multiple programs allowing faster review of medical devices in order to get them to market more quickly. Some of the FDA’s efforts have been highly visible, such as the Breakthrough Devices program in the 21st Century Cures Act and the Software Precertification pilot program in the FDA’s Digital Health Innovation Action Plan. Others have been less trumpeted but are still significant developments for device manufacturers. This series of programs is consistent with FDA’s trend of making market entry for devices more efficient and reducing regulatory barriers for devices with low risk profiles and for devices that may be desperately needed by specific patient populations.
Faster 510(k) Review
On September 7, 2018, FDA unveiled the Quality in 510(k) (“Quik”) Review pilot program, which allows device manufacturers to submit premarket notifications electronically, as long as the device is classified under one of the specific product codes included in the pilot program (see the Quik Review webpage for the full list) and is not a combination product. FDA’s goal is to review 510(k) applications for devices that meet the eligibility requirements within 60 days, rather than the typical 90 days for traditional applications. While the inclusion of some of the device types in the pilot (e.g., eye cups and contact lens cases) is not surprising given their low-risk, FDA has also included some higher risk Class II devices, such as surgical lasers, certain endoscopic equipment, and certain imaging devices (e.g., MRIs and stationary X-rays). No doubt, FDA sees this pilot program as a potential opportunity to improve the entire 510(k) process, which will be a huge advantage for device manufacturers seeking expeditious review and commercialization.
Better Understanding of Uncertainty in Benefit-Risk Analyses
On September 6, 2018, FDA issued a draft guidance entitled Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions, in which FDA discusses its approach to uncertainty in benefit-risk analyses supporting approval through PMA, de novo, and humanitarian device exemption pathways. While the draft guidance does not provide definitive criteria for “acceptable” uncertainty, FDA outlines the factors considered during review, such as the extent of the device’s benefits, risks, and the uncertainty involved, as well as the size of the potential patient population, the feasibility of substantial premarket studies, and the ability of postmarket data to resolve residual uncertainty. FDA’s device review process typically demands as much specificity as possible, so it is helpful when the Agency acknowledges that uncertainty is a factor and describes its approach for taking uncertainty into account.
The Private Payor Program
A recent FDA Voice post by Commissioner Gottlieb highlighted the Private Payor Program, a recently introduced CDRH initiative that is gaining momentum. In February 2016, FDA issued a request for expressions of interest from private payors about providing feedback to manufacturers on medical device clinical evidence generation and coverage as part of pre-submission meetings. To date, the following private payors and health technology assessment organizations have expressed interest and joined the program:
- BlueCross BlueShield Association
- CareFirst BlueCross BlueShield
- Duke Evidence Synthesis Group
- ECRI Institute
- Kaiser Permanente
- National Institute for Health and Care Excellence (NICE)
- United Health Group
The Private Payor Program provides manufacturers a voluntary opportunity to have any of the participating organization attend a pre-submission meeting between the manufacturer and FDA to discuss clinical trial design and evidence gathering to support and facilitate future coverage determinations. Although most device manufacturers try to gather sufficient clinical evidence of safety and efficacy to support regulatory approval or clearance as well as coverage and reimbursement decisions, this program allows manufacturers to engage with payors early in the process instead of finding out that additional data is needed to obtain a positive coverage decision. It is also worth noting that device manufacturers may also request that CMS participate in pre-submission meetings to provide feedback on clinical trial design with respect to potential coverage considerations.
Commissioner Gottlieb stated in his post that ten engagements between manufacturers and private payors or health technology assessment organization have taken place since the program was created. These are opportunities that more device manufacturers should consider taking advantage of when preparing to gather clinical data to support a PMA or de novo application.