SummaryTo decrease time to market and align data collection efforts, manufacturers must now engage with CMS and FDA more thoughtfully and earlier in the Category B IDE process.
FDA and CMS continue to look for new ways to gain efficiencies during the device approval and coverage process.
Since policy decisions made by one agency are likely to influence the other, there is a recognized need for both formal and informal collaborations between the two organizations.
For example, changes to the Investigational Device Exemption (IDE) provisions in the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) may make it more difficult for manufacturers to get their trials reimbursed from CMS. FDASIA states that the FDA “shall not disapprove” an IDE even if the study design is insufficient to support approval. As a result, IDE approvals may not predict as accurately the future pre-market approval for a product, and CMS is more likely to get involved early during the FDA’s IDE review process to determine if investigative devices or trials are reasonable and necessary. These changes will likely trigger CMS to revisit its policy around coverage of Category B IDEs.
It is becoming increasingly likely that the two agencies will collaborate on guidance for approving studies and assessing coverage for Category B IDEs.