Panel Recommendation Options
For
The
Medical Device Amendments to the Federal Food, Drug and Cosmetic Act (Act), as
amended by the Safe Medical Devices Act of 1990, allows the Food and Drug
Administration to obtain a recommendation from an expert advisory panel on
designated medical device premarket approval applications (PMAs) that are filed
with the Agency. The PMA must stand on
its own merits and your recommendation must be supported by safety and
effectiveness data in the application or by applicable publicly available
information. Safety is defined in the
Act as reasonable assurance, based on valid scientific evidence that the
probable benefits to health {under conditions on intended use} outweigh any
probable risks. Effectiveness is
defined as reasonable assurance that, in a significant portion of the
population, the use of the device for its intended uses and conditions of use
{when labeled} will provide clinically significant results.
Your
recommendation options for the vote are as follows:
1.
APPROVAL – If there are no
conditions attached.
2.
APPROVABLE with conditions – The panel may recommend that the PMA be found approvable subject
to specified conditions, such as physician or patient education, labeling
changes, or a further analysis of existing data. Prior to voting, all of the conditions should be discussed by the
Panel.
3.
NOT APPROVABLE – The panel may recommend
that the PMA is not approvable if:
·
the
data DO NOT provide a reasonable assurance that the device is safe,
OR
·
the
data DO NOT provide a reasonable assurance that the device is effective,
under the conditions of use prescribed, recommended,
or suggested in the proposed labeling.
Following
the voting, the Chair will ask each panel member to present a brief statement
outlining the reasons for their vote.
Revised: December 10, 2004