Page 247 - Assurance of Sterility for Sensitive Combination Products and Materials

224 Assurance of sterility for sensitive combination products and materials

The Q-Submission Program provides the opportunity for interaction
with the FDA from the early stages of device design through the regulatory
process, while supporting the FDA’s goal of facilitating new medical device
development. The guidance presents an overview of the various types of
Q-Subs available through the FDA, as well as general timeframes, methods
of feedback, and additional information.
One type of Q-Sub, known as a Pre-Submission (Pre-Sub) is a request for
FDA feedback prior to an intended premarket submission (i.e., IDE, PMA,
HDE, De Novo request, 510(k), Dual, BLA, IND), Accessory Classification
Request, or CW. Pre-Subs include specific questions for which feedback is
provided in the form of a written response or a written response followed
by a meeting in which any additional feedback or clarifications are docu-
mented in meeting minutes. These meetings may take the form of telecon-
ferences or in-person meetings.
The Agency will, after reviewing the information, develop feedback to
address the submitted questions and, if a meeting is requested, work with
the submitter to determine a mutually agreeable meeting date and time.

9.2.1 Additional points to consider
For several reasons, it is highly encouraged that industry begin com-
municating early with the FDA, and with the right component of the
Agency. For some particular types of devices the Agency may have issued
a device-specific guidance with recommendations that differ from those of
other device types. Similarly, there may be FDA-recognized standards that
have special sections or annexes dedicated to a particular device type (e.g.,
ethylene oxide residual limits for intraocular lenses).
Upon initially contacting the Agency, it might be determined that de-
veloping a benefit-risk analysis in support of any departure from established
standardized practices could be of great value. Such an approach could be
applied to proposed alternatives to standardized sterility assurance levels,
the use of alternative sterilants and sterilization methods, or inclusion of
alternative and unique device materials. Such an analysis should address
the principle factors that would likely be taken into consideration during
the premarket review process—including an evaluation of risks (and risk
mitigation measures) and anticipated benefits associated with the proposed
approach. Consulting FDA guidance documents that address the factors to
consider when making benefit-risk determinations for PMAs and De Novo
classifications, and for IDEs, could be useful.