The FDA’s Guidance to the Breakthrough Devices Program states the agency “may accept a greater extent of uncertainty of the benefit-risk profile for these devices if appropriate under the circumstances.” The CMS recently began providing supplemental reimbursement through New Technology Add-On Payments for “Breakthrough Devices.” CMS has waived a nearly two-decade criterion that devices receiving such payments must provide a “substantial clinical improvement” to Medicare beneficiaries. These policies will accelerate the approval and adoption into clinical practice of novel medical devices which may later be determined to not meet the statutory standard of reasonable assurance of safety and effectiveness (FDA) and/or “reasonable and necessary” (CMS). A crucial, but underutilized, regulatory authority can improve patient safety: conditional approval with withdrawal of approval when (1) clinical data demonstrate the threshold of reasonable assurance of safety and effectiveness is not met or (2) postmarket studies are not completed in a timely manner to demonstrate safety and effectiveness. It is rarely used, but there is precedent for FDA revocation of pharmaceutical approvals. In addition, payor coverage should be conditional (and proportional) on data of safety and effectiveness and withdrawn for data showing net harms or if data are not generated in a timely manner.