What FDA offices and panels will be responsible for reviewing my product?
How has the FDA treated similar products in the past?
Should I file a 510(k) or a PMA?
Is a clinical study required (whether 510(k) or PMA)?
What kind of quality system do I have to have?
Who is the primary payer for my device?
Can I use an existing CPT code for my device?
What devices are similar and how are they reimbursed?
How long will my clinical trial take?
How long will reimbursement approval take?
Can I use one clinical trial to satisfy both FDA and CMS?
What is a Medical Device?
In the context of orthopedics, according to Section 201(h), a
medical device is any instrument, implant or component which is (a)
intended for use in the diagnosis or treatment of disease or (b)
intended to affect the structure of any function of the body. If,
however, the technology achieves its primary effect through
pharmacological action, the technology is considered a drug.
Device Classifications
Devices may be classified as Class I, Class II, or Class III, depending
on their invasiveness and risk. These devices may require clearance from
the FDA prior to marketing the device. For more information, see the
FDA web site.
FDA Clearance
Class II and Class III devices generally require FDA approval prior to
marketing the device. The FDA does not approve the device itself,
rather, they give their approval that the device can be marketed.
Approval may come through either filing a 510(k) or a PMA.
510(k) Clearance
Filing a 510(k) involves demonstrating to the FDA that the product is
substantially equivalent to one or more devices that are already legally
for sale in the U.S. A 510(k) submission includes and indication for
use, description of the device, proposed labeling, and a justification to
support the substantial equivalence claim.
Substantial Equivalence does not mean the new and predicate devices must
be identical, only that they have the same intended use, technical
characteristics, safety and effectiveness. For more information,
click here.
A 510(k) for an orthopedic device does not have to be another orthopedic
device. For example, a 510(k) for an annulus repair device may use a
hernia repair device as a predicate device if the manufacturer can
justify substantial equivalence.
PMA Clearance
Filing a PMA involves collecting and submitting clinical studies as part
of the approval process. The PMA submission contains detailed
information on indications, operation, performance, manufacturing,
packaging, and labeling as well as non-clinical and human clinical
trials. The process is lengthy and costly, but produces a significant
competitive advantage. There is substantial evidence that the companies
obtaining PMA approval have higher valuations than companies obtaining
510(k) approval.
How Much Does It Cost
The filing fee for a 510(k) is approximately $4,000. Consulting and
preparation time usually bring the total budget for a 510(k) filing to
$10,000 to $25,000. This is substantially lower than the cost of filing
for a PMA which may cost in excess of $3M. A PMA will typically include
a pilot study ($0.5M+), clinical studies ($2M+), and consulting and
registration fees ($0.5M+)
Postmarket Surveillance
If the device is a permanent implant, manufacturers must conduct
postmarket surveillance to gather safety and efficacy data. Postmarket
surveillance monitors the device performance while it is used in the
general population. The FDA may require data for an additional 2-3 years
after approval. For more information, see
www.fda.gov/cdrh/postsurv.
Working with the FDA
The FDA has several advisory committees that are made up of members
outside of the agency. These committees or panels are made up of medical
and scientific experts who provide independent professional and
technical expertise. Some of the panels that pertain to orthopedics are:
Orthopedic and Rehabilitation Devices Panel, Neurological Devices Panel,
and the General and Plastic Surgery Device Panel. These panels are
actively involved in trial design and other factors of interest to
manufacturers. The panel roster and meeting transcripts are available
at: www.fda.gov/cdrh/panel. The upcoming meeting schedule is available
at www.fdaadvisorycommittee.com.
The FDA website is a tremendous resource for companies developing
medical devices. A good place to start for general advice is
www.fda.gov/cdrh/devadvice.
Another
useful site identifies guidance documents and FDA published memoranda on
specific topics.
Finally, it helps to become familiar with the reviewing staff in a
particular division of CDRH and to learn what they expect in clinical
trial submissions. It is important to establish an honest working
relationship and to respond quickly to challenges from the FDA in order
to minimize the length and maximize the success of your trial.
Don’t Forget CMS
While the FDA is responsible for the safety and efficacy of devices, it
does not guarantee reimbursement. Reimbursement requires interaction
with CMS (Center for Medicare and Medicaid Services). The CHARITE case
in 2005 is evidence of the independence of these agencies. While the FDA
approved the device for marketing, CMS denied payment. It is important
in trial design to consider whether it is possible to collect data to
satisfy both FDA and CMS requirements.
