Approvals for Medical Devices Could Fade
Faster approval times have made Europe an early
market for new medical devices, with U.S. approval often following a few years
That could be changing as regulators in the U.S.,
Europe and Japan look to unify their approval processes, according to an article
on investor website Seeking Alpha.
“The geographical strategy that device makers have
historically relied on may change now that we’re seeing greater regulatory
convergence among the three major markets for device makers,” said Debbie Wang,
an analyst with Morningstar Research Inc. who wrote the article.
The bad news for device makers is that approvals
could become tougher in Europe, rather than easier in the U.S., according to
In Europe, medical device makers now are required to
show the risk-to-benefit ratio of their products based on clinical data.
Before, they only had to show the safety of the
device at the time of implant with no effectiveness requirements.
Post-marketing registries to track patients now are
mandatory in Europe.
Wang said she expects device makers to face a longer
clinical process, as well as higher development costs in Europe.
“This could lessen the incentive to head for Europe
first,” she said.
Typically, device makers introduce products in
Europe, followed by Food and Drug Administration approval and then a Japanese
launch about three years after U.S. approval. Wang’s piece also addressed some
changes underway at the FDA.
“Much uncertainty” surrounds tightening standards
for the FDA’s 510 (k) medical device clearance program for approving devices
similar to those already on the market, she wrote.
Earlier this year, the FDA released a report
containing more than 70 proposed changes to the program.
Some 3,000 medical device applications per year, or
a majority of those submitted to the FDA, are evaluated through 510 (k).
“Considering over 85% of medical device approvals
are handled through (the process), versus the more rigorous premarket approval
pathway, we can see why the medical device companies are sitting on pins and
needles to see how the dust settles,” Wang said.