Reviewed together. Decided separately.

Most novel devices clear FDA and then wait — sometimes years — before Medicare decides whether to pay for them: two federal reviews of related evidence, run end to end instead of side by side. One program runs them side by side instead, and it is open to almost nothing. A 510(k) device cannot enter it at all.

Two agencies, two clocks, one file

The FDA–CMS Parallel Review Program lets a sponsor have its PMA or De Novo submission and CMS’s National Coverage Determination reviewed concurrently rather than sequentially — agreeing on pivotal trial design first, then a concurrent evidentiary review once FDA has the completed submission. Neither agency changes its own legal standard to participate. FDA still decides safety and effectiveness. CMS still decides whether the item is reasonable and necessary for Medicare beneficiaries under 42 U.S.C. 1395y(a)(1)(A). The program changes when each agency starts looking, not what either one is looking for.

Eligibility is narrow by design. A device qualifies only if it will need an original or supplemental PMA or a De Novo request, has had substantive pre-IDE contact with FDA or an approved IDE, falls inside a Medicare Part A or Part B benefit category, and — the condition that rules out most candidates on its own — is not already subject to an NCD. A sponsor nominates the device directly. A 510(k) device, by definition the lower-risk track, has no door into the program at all.

Permanent since 2016. Still rare.

FDA and CMS piloted the program by joint notice in October 2011 and made it a standing, open-ended program by a second notice in October 2016. The pilot drew roughly sixty inquiries and twenty-six applications; ten sponsors were accepted, and only two — Foundation Medicine’s FoundationOne CDx and Medtronic’s Symplicity renal denervation system — reached a completed concurrent review. The permanent program caps enrollment at five devices a year, a limit the two agencies set for themselves, not one Congress wrote.

The clock runs twice as fast. The door is open to almost no one.

The practice

For the handful of sponsors it reaches, parallel review is the one structural way to close the approval-to-coverage gap before it opens. For a portfolio watcher, the practical read is the opposite: seeing a competitor’s PMA approval or De Novo grant is not, on its own, a signal that a coverage determination is close behind it. Assume the two clocks ran separately unless you know — from the sponsor’s own disclosures, not the approval record — that the device was one of the five a year that didn’t. This is regulatory intelligence about how the two reviews can align, never advice about whether a specific device’s coverage timeline will.