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About A Combination
Product
A combination product is :
1. A product comprised of two or
more regulated components (i.e., drug/device, biologic/device,
drug/biologic, or drug/device/biologic) that are physically,
chemically, or otherwise combined or mixed and produced as a
single entity;
2. Two or more separate products
packaged together in a single package or as a unit and comprised
of drug and device products, device and biological products, or
biological and drug products;
3. A drug, device, or biological
product packaged separately that according to its investigational
plan or proposed labeling is intended for use only with an
approved individually specified drug, device, or biological
product where both are required to achieve the intended use,
indication, or effect and where, upon approval of the proposed
product, the labeling of the approved product would need to be
changed (e.g., to reflect a change in intended use, dosage form,
strength, route of administration, or significant change in dose);
or
4. Any investigational drug, device,
or biological product packaged separately that according to its
proposed labeling is for use only with another individually
specified investigational drug, device, or biological product
where both are required to achieve the intended use, indication,
or effect.
Examples of combination products where the components are
physically, chemically or otherwise combined are :
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Drug-eluting stent; pacing lead with
steroid-coated tip; catheter with antimicrobial coating; condom
with spermicide
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Skin substitutes with cellular
components; orthopedic implant with growth factors
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Prefilled syringes, insulin injector
pens, metered dose inhalers, transdermal patches
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