U.S. and global regulatory requirements, which is why it’s vital for
manufacturing and regulatory affairs to work collaboratively.
The level of involvement, control, and notification that is required depends on the type of device, its classification, where and
how it is marketed, and a host of other factors. For example, a U.S.
medical device manufacturer selling a device in another country
may need to notify that country’s regulatory agency if it wanted
to move an operation to a new facility or supplier. In addition, because most regulatory agencies expect high-level change control
detail, it’s possible that the authorities not only would require the
company to notify them of such a change, but to halt imports of
any products into the country until the appropriate documentation has been reviewed and approved. The RA team is equipped
to help manufacturing navigate these complicated regulatory nuances so work can be completed with as little disruption or risk to
the company as possible.
Currently, U.S. regulations are not on par with European and
other international regulations for post-market surveillance. For
the most common 510(k) devices, U.S. regulations do not require
manufacturers to actively collect data on device performance. Instead, they tend to rely on complaints from the field and report
only the most serious adverse events, even though a lack of complaints does not mean the device is performing well.
In regions outside of the U.S., after a product gets to market
and is in use, the expectation is that the medical device company
will diligently, consistently and proactively follow up on their
products and track:
United States, the firm often finds itself unprepared and ill-
equipped. This especially is true for companies with no experi-
ence dealing with international medical device regulations. Their
assumption is that since it was cleared through the FDA, it should
be a fairly straightforward process getting it to market in Europe
or Asia. But without extensive post-market data, this couldn’t be
further from the truth.
This mindset with U.S. companies and within the FDA is gradually changing. In fact, once the present 510(k) issues are sorted out
in the United States, it’s very likely that the FDA will start scrutinizing post-market surveillance as well. The FDA already has started
putting the framework together for new post-market surveillance
requirements, which means that medical device companies should
expect to soon feel the pressure to gather better information about
their device’s total product life cycle and to implement more robust
risk management and change control procedures.
To Protect and Serve
Regulatory professionals often are referred to as “police” in today’s global medical device marketplace, and much like local
law enforcement, regulatory affairs’ job is to two-fold: Protect
the medical device manufacturer from getting into trouble with
the;authorities;regulating;them;;and;serve;the;needs;of;all;stake-holders by helping to ensure that the company gets safe, reliable
products to market efficiently and cost-effectively—without any
barriers to clearance.
To adequately do their job, RA must be included in the conversations that take place at each stage of the device’s life cycle. By
on test plans, reports, and timelines, medical device manufacturers will be better able to succeed with their innovations and with
For medical device companies that do not have an in-house
regulatory affairs group, it’s essential to work with a company
that has extensive RA expertise, direct communication with the
FDA, and can provide accurate and prompt clarification on PMA
and 510(k) submissions. v
Kellen Hills is the senior regulatory consultant for Orchid Orthopedic Solutions. In addition to designing and manufacturing implants
and instruments for the orthopedic, dental and cardiovascular markets, Orchid provides regulatory expertise, document preparation, and
submission strategies to help medical device companies ensure regulatory compliance from concept to post-market surveillance.
The only efficient, cost-effective, and compliant way for U.S.
medical device companies to get their products to market in
the United States and abroad is to involve regulatory affairs
in every aspect of a medical device’s life cycle.