Biomedical Engineering Reference
In-Depth Information
strategy listing milestones for the project, as well as specific requirements for
assessing those milestones in order for the project to progress. As much as is possible,
pass/fail criteria for each milestone should be developed at this stage. The plan is
initiated after approval by the management after review and approval by a Design
Committee. The Design Committee normally consists of representatives of
Engineering, Manufacturing, QA, Medical Director, Marketing, Sales and Regulatory
Affairs.
The Design Plan must include periodic review and approval by the Design
Committee that evaluates its progress and the resulting design output. Should
changes in the Plan or Input be required or desired they must be changed by a
formal Change Order Procedure. As the project progresses, design outputs, in the
form of data from testing or validations, should be reviewed by the Committee to
ensure that Design Inputs and Design Requirements are being met.
3.2.3.1 Regulatory Affairs
As early as possible in the design process, Regulatory Affairs should provide an
assessment of the U.S. and European Union regulatory requirements for
introduction of all new/revised devices. This should include determining whether
the new/revised device requires a PMA/PMA Supplement, Humanitarian Use
Device (HUD), 510(k) pre-market notification, IDE, or clinical trial and related
approvals required by the FDA or Notified Bodies, prior to its introduction into
commerce. No finished revised/new devices should be distributed commercially or
for clinical investigation anywhere in the United States or in the European Union
unless the requirements stipulated by Regulatory Affairs, the FDA and Notified
Body (as applicable) have been met.
3.2.3.2 HUD
If it is determined by Regulatory Affairs that a new/revised device qualifies as a
humanitarian-use device (HUD), a Humanitarian Use Exemption (HUE) should be
filed with FDA and the device may be shipped in the USA as directed in the HUE
approved by the FDA.
3.2.3.3 Consultation with Regulatory Bodies
As needed, Regulatory Affairs should consult with the FDA or Notified Bodies to
determine the regulatory requirements for introducing the new/revised device and
then include documentation of the recommendations and/or requirements in the
DHF.
3.2.3.4 Patents
Novel and useful designs may be protected by one or more patents. Prior to the
full development of a new design it is essential to determine its patent status at an
early stage. One should determine:
