Biomedical Engineering Reference
In-Depth Information
a 510(k). Specifically, a PMA annual report must be filed with the ODE each year and
changes in labeling, materials, manufacturing, quality methods, and specifications as well
as changes in manufacturing location must all be reported to, and approved by, the ODE
in advance. This is done through the PMA supplement process.
12.3.3.1 The PMA Process
PMAs are large and complex documents, often greater than 2000 pages. It can frequently
take several years to obtain all the preclinical, clinical, and manufacturing data neces-
sary for the PMA. It is essential that the PMA preparation effort be well planned, with
good coordination between all functional areas involved in the development process and
advance research, before a regulatory strategy is prepared and it should also include a
wide variety of sources. Shortly after a PMA device is approved, the approval letter, sum-
mary of safety and effectiveness, and official labeling are placed on the CDRH web site.
These documents provide greater technical and regulatory detail than a 510(k) summary.
The PMA submission itself is not available via the Freedom of Information process.
Once the indication for use and the device description have been established, it is impor-
tant to confirm the key elements of the development plan with the appropriate reviewing
branch within the ODE. The device developer may choose to obtain this information via
an informal telephone call, an informal pre-IDE (Investigational Device Exemption) meet-
ing, a formal designation meeting or a formal agreement meeting. Less formal meetings,
while they do not generate binding agreements, can encourage very productive techni-
cal exchanges. The choice of meeting type involves balancing business, regulatory, and
clinical needs.
A PMA development plan should be executed when it has been established and
reviewed by the ODE. Generally, multiple activities, such as manufacturing development,
validation, preclinical functional testing, biocompatibility testing, and clinical testing
proceed along parallel and often simultaneous lines. In some cases, it may be clear during
the planning phase that some data, such as information that pertains to the manufacturing
process or preclinical testing data, may be available long before the clinical trial has
ended, in which case a process called a modular PMA may be advantageous. This
consists of submitting completed pieces of the PMA to the ODE rather than sending
all the data at the very end. For this, a sponsor must submit a shell or outline of the
PMA and obtain approval from the ODE. The shell, which describes the contents of
each module, is submitted to the ODE for independent review. Once the review of a
module has been successfully completed, the ODE sends the sponsor a letter stating that
the module is 'locked' and will not be reopened unless some portion of data already
submitted changes in later stages of the development process. When the last module is
submitted, the ODE considers the PMA complete [10].
12.3.4 The Quality System Regulation
The QSR regulates both the device development and the manufacturing process for all
Class II and Class III devices from the beginning of the development phase until the
device is no longer supported by the manufacturer. It covers the manufacturing process
for a number of Class I devices, but does not cover the research process for any medical
