Pathways’ Pick of the Week: Checking In Around the Globe

[For a complete roundup of medtech policy happenings that should be on your radar this week, deeper analysis of the sector, and a comprehensive inventory of global medtech policy documents check out Market Pathways. If you don’t subscribe, sign up for a free trial.]

In this edition of Pathways’ Pick of the Week, it’s a four-for-one deal, spotlighting important developments from US FDA, Brazil’s ANVISA, the EU, and the World Health Organization. First, what’s next for MDUFA?

User Fee Talks Coming this Fall?

It’s hard to look away from the blinding rate of emergency authorized COVID-19 tests in recent months (more than 200 since March, counting authorized lab-developed tests). But more routine device and IVD review activities continue in the background, and the time for a closer look at the broader program is coming soon, with upcoming negotiations to reauthorize device user fees. The current MDUFA IV program expires two years from now, but the process for forging MDUFA V is already behind the eight ball. FDA has twice postponed the public meeting necessary to kick off user-fee reauthorization talks, and has yet to set a date publicly. But industry stakeholders have recently been told to expect a meeting in the fall, likely in October, Market Pathways has learned.

The pandemic experience is likely to have some impacts on how both FDA and industry will approach negotiations, but the two sides could look at the issue differently. During aJune talk, CDRH Director Jeff Shuren presented numbers showing the center’s premarket review volume had essentially doubled in 2020 compared to 2019 including EUA activity. On the one hand, FDA might look at that as evidence of the need for more user-fee revenue from industry. But, on the other, companies may point out how much the agency has been able to accomplish in recent months (including not missing any of its MDUFA IV performance goals amid COVID-19) without a major influx of extra resources. Let the negotiations begin!         

ANVISA Eyes Price Monitoring

A bit southward, Brazil’s ANVISA made progress toward establishing a public pricing database in the country for implantable devices. The regulatory agency was tasked with finding a solution to improve consistency and transparency in domestic pricing of medical devices as part of the Brazilian government focus to rein in corruption. ANVISA launched the pricing database effort in earnest last August with the release of a regulatory impact assessment. Now, a year later it rolled out specific proposals for public consultation.

The agency outlines a plan for a public database that would initially focus on cardiac stents, valves, and implantable defibrillators and would include price and technical attribute data that come from a combination of mandatory company reports to the government and public sources. Manufactures are looking through the proposals for any red flags before an October 5 comment deadline. But there is an expectation that industry will, by and large, go along with the plans, thankful that ANVISA didn’t elect to take an alternative approach: direct price controls. (Look for more details on ANVISA’s proposals in an upcoming Market Pathways article.)

Nod to MDSAP in Brussels

One thing FDA and ANVISA have in common is they are both members of the Medical Device Single Audit Program. MDSAP, established by the International Medical Device Regulators Forum (IMDRF), is a successful example of harmonization in the medtech sector, with a third-party audit process that can stand in for different regulatory or compliance requirements in five countries at once (also including Australia, Japan, and Canada). But a very noticeable gap in the program has been the absence of the massive European medtech market. While the EU has signed on as an “official observer” in recent years, it’s been reluctant to join as a member that formally recognizes MDSAP audits in some capacity. That freeze-out may be starting to thaw.

In April, the EU Medical Device Coordination Group (MDCG) issued emergency COVID-19 guidance that allows MDSAP audits to serve as a possible temporary alternative to onsite notified body audits for device recertifications and modifications under the current device directives. And this week MDCG issued guidance that for the first time spells out a role for MDSAP audits in the context of the new Medical Device and IVD Regulations. To be sure, MDSAP audits can’t replace any EU notified body audit in full, the guidance makes clear. But it’s possible for a notified body to take the results of an MDSAP audit into account when planning what to focus on during an annual, mandatory surveillance audit. The body may be able to skip quality system elements addressed by MDSAP during its audit. Or, on the flip side, if the MDSAP inspection identified deficiencies, it might prompt a closer focus by the notified body on those issues. The MDCG guidance includes tables mapping MDR requirements to MDSAP audit components, which could be an important step toward more formal EU adoption of the global program.  

The WHO, What, and Why of Reg Practice

When it comes to global medtech regulatory policy, IMDRF is the group that many look to first for consensus. But the World Health Organization is staking out a larger role for itself in this realm. WHO already has established its “prequalification” program for IVDs, which is influential in the procurement of tests by the United Nations and by developing countries. The organization is also developing guidance documents to help support developing regulatory authorities around the world. On August 10, WHO issue a draft guidance for consultation on “good regulatory practices” for oversight of devices and drugs. This is actually a second go-round of consultation after an earlier version of the document was circulated in 2016. WHO will collect comments through September 11 and hopes to have something ready for adoption by October.