2018 was anything but a slow year for regulatory developments in the world of medical technology, but there is still plenty to look forward to for 2019. Following are several key developments that will do much to shape the prospects for industry going forward.
Rules of Civil Procedure Revised
This first item is not an FDA regulatory matter, but refers to something that took place in early December 2018, although the real impact is unlikely to be felt until 2019 starts to unwind. The Advisory Committee on Civil Rules had amended several of the Federal Rules of Civil Procedure earlier in the year, and those changes, including those applied to Rule 23, went into force Dec. 1.
One of the changes to Rule 23 allows the use of one or more electronic methods of contacting members of a class action regarding settlements, but a more significant change is in the method for dealing with bad objectors. Up to Dec. 1, a court had to approve the withdrawal of each individual objection to a settlement, but that requirement is no longer in force. Those whose objections are seen as an impediment to a reasonable settlement can simply withdraw their objections without forcing the court through a time-consuming review of the objection. While there are other issues related to the Federal Rules of Civil Procedure that are in need of redress, these latest changes should at least expedite the process considerably.
Device Tax Again Topical
Despite that it is not scheduled to resume until after 2019, the 2.3 percent tax on medical devices is again in the news thanks to the prospect that it might be pushed back an additional five years. That is the stated intent in connection with legislation that would provide some fixes for the tax overhaul signed into law at the end of 2017.
That legislation, which arose from the House Ways and Means Committee, seems to have been pushed aside by the latest budget impasse, however, although the fact that the tax does not resume for another year should give industry some comfort. Device makers will argue that their budgeting for activities such as research and development require more than a 12-month window, but it is not at all clear whether House Democrats are interested in H.R. 88 as currently written, if at all. Consequently, it seems at least somewhat likely that the device tax suspension will once again come down to the 11th hour.
As an aside, the budget problem involves the FDA budget, and one line of thinking is that the stand-off between the White House and Capitol Hill has better odds of resolution once the 116th Congress is sworn in on Jan. 3. In the meantime, user fees are funding much of the agency’s work, but routine manufacturing facility inspections may be held up in the meantime.
FDA’s Clinical Lab Regulation
This issue has been percolating for several years now, and includes an FDA discussion paper published in early 2017. That effort has been supplanted by a “technical assistance” provided to Congress in August 2018.
The original impetus for the FDA’s technical assistance was to help Congress refine the Diagnostic Accuracy and Innovation Act, but that bill has given way to the Verifying Accurate Leading-edge IVCT Development Act of 2018. Both bills were primarily sponsored by Reps. Diana DeGette (D-Colo.) and Larry Bucshon (R-Ind.) although the VALID Act is still in the form of a discussion draft, according to DeGette’s congressional webpage.
The bill makes reference to a precertification concept similar to that seen in digital health, which would be applied to moderate-risk tests, while high-risk tests would still be subject to the more traditional premarket review processes. Other interested parties include Sen. Orrin Hatch (R-Utah), who said in a statement that supporters will push the bill in the 116th Congress, suggesting that 2019 might finally be the year that the agency’s clunky approach to diagnostics regulation will receive a much-needed overhaul.
Guidance Agenda for 2019
The FDA’s device center is always busily compiling a new round of guidances, but one of the priority guidances of interest as announced in the device guidance agenda is a draft for demonstrating substantial equivalence through the use of performance criteria. This draft will pertain to abbreviated 510(k)s, according to the CDRH guidance agenda, but this draft might be as important as any that will emerge in this new year, thanks in part to what some observers are likely to see as an end run around the statute. The agency announced it would revisit the 510(k) program in an November announcement which also evinced some hostility toward the substantial equivalence standard.
There are a number of existing guidances that may be up for review as well, including the 1999 guidance for surgical mesh 510(k)s. That document is on the agenda for the obvious reason, including that the agency has up-classified these meshes for at least one indication, not to mention the ongoing patient concerns about mesh implants that have gone bad.