Medical Design Briefs - August 2024 - 2

FDA Releases Draft Guidance for Drug-Delivery Devices
A
t the end of June, FDA released a
draft guidance that is designed to facilitate
and streamline development of
stand-alone devices and combination
products by improving the consistency of
drug-delivery performance information
included in applications and submissions.
The guidance covers products with device
constituent parts that are intended to deliver
drugs and biological products.
According to FDA, the drug-delivery
performance information is designed to
demonstrate that the device drugdelivery
function consistently performs
as intended. The guidance includes examples
of potential essential drugdelivery
outputs for several product
types including prefilled syringes, injectors,
nasal sprays, and inhalation devices.
Per the new guidance, while design verification
and validation activities are intended
to address all design inputs and
outputs, it offers recommendations that
are specific to essential drug- delivery outputs
(EDDOs). Appropriate verification
and validation activities for EDDOs depend
on the conditions (e.g., environmental
conditions) to which the product
will be exposed during production, shipping,
storage, and preparation and the
conditions associated with use.
Design verification testing should include
an evaluation of EDDOs that may
change over time or have age-related
failure modes. Data provided to support
a proposed expiration date should
demonstrate that EDDO performance
is maintained.
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For a combination product, such data
can be derived from design verification
shelf-life testing, stability testing, or both.
In addition, the guidance indicates that the
final determination of the expiration date
is informed by the maintenance of EDDO
performance and drug stability testing.
EDDOs that would not change over time
(e.g., physical dimensions such as needle
length) would not warrant evaluation.
The testing to support a proposed expiration
date should include consideration
of the number of repeat uses of the product
to deliver the drug and the potential
impact of any associated cleaning and reprocessing
cycles and interim storage between
uses.
To support the proposed expiration date
for combination products, verifying the
performance of certain EDDOs over time
may be accomplished by relying on or leveraging
drug stability testing results (e.g.,
for EDDOs subject to chemical degradation
such as those for a vaginal system).
The guidance includes EDDO output examples
for prefilled syringes and autoinjectors
as well as tables with potential outputs
based on product type. Comments can be
submitted through September 9, 2024.
Sherrie Trigg
Editor and Director of Medical Content
Read the full Draft Guidance,
" Essential Drug Delivery Outputs
for Devices Intended to Deliver
Drugs and Biological Products
Guidance for Industry "
2
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Medical Design Briefs, August 2024
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Medical Design Briefs - August 2024

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