FDA Guidance - Drug Device Combination Products

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Drug Device Combination Products

• Operon Strategist

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• The US Food and Drug Administration (FDA) has
  finalized guidance for industry and agency staff
  on the use of premarket pathways for combination
  products, including providing details on how the
  lead FDA center is determined and current
  thinking about cross-labeled products.
• While the guidance is not binding, it provides
  industry participants with valuable insight into
  how the FDA will regulate combination drug-device
  products moving forward and provides some clarity
  on information device makers will need to submit
  in premarket review applications. The guidance
  reflects changes to the Food, Drug, and Cosmetic
  Act implemented in the 2016 21st Century Cures
  Act.
• Operon Strategist as a reliable medical device
  consultant assists companies and medical device
  manufacturers by providing consulting services
  that support the registration of drug-device
  Combination Products. We have experience with
  each constituent part and the GMP regulations
  that together form the basis for their
  development and manufacture Drug (21 CFR
  210/211), Device (21 CFR 820) and 21 CFR
  Combination Products (21 CFR Part 4).
• We also service clients in Saudi Arabia.

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Combination Product Defined

• There are three basic types of medical products
  biological products, drugs, and medical devices.
  The laws and regulations governing each type
  developed at different times, although in recent
  years there have been significant harmonization
  efforts, particularly for biological products and
  drugs. A combination product is a product
  composed of two or more of these three types,
  such as a biological product distributed in a
  prefilled syringe (a biological product-device
  combination product) or a drug-coated cardiac
  stent (a drug-device combination product).
  Appropriate regulation for combination products
  must address safety and effectiveness issues for
  both components.
• The term combination product encompasses many
  types of products, including
• Single entity combination products, such as
  prefilled drug delivery systems.
• Co-packaged combination products, such as
  surgical trays that include both surgical
  instruments and antimicrobial swabs.
• Cross-labeled combination products, which are
  separately packaged products intended for use
  only in combination with other specified
  products, such as photosensitizing drugs and
• activating light sources.

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Takeaways

• Combination products continue to be a priority
  area for innovation in the biopharmaceutical,
  medical device, and digital health sectors. The
  final guidance is an important step towards
  greater clarity around how FDA conducts premarket
  review of combination products. As with all FDA
  guidance, FDA accepts comments at any time which,
  for this final guidance, enables stakeholders to
  provide feedback to FDA as it continues to shape
  its policies on combination products.
• The final guidance also relates in part to the
  U.S. Court of Appeals for the District of
  Columbia Circuits April 2021 decision in Genus
  Medical Technologies, LLC v. FDA, which held that
  any product meeting the definition of both a drug
  and device must be regulated as a device. FDA
  intends to publish a notice in the Federal
  Register with a list of approved drugs that will
  transition to device status, although some have
  argued that Genus does not give FDA the authority
  to reclassify existing products. FDA intends to
  solicit comments before the list is finalized.

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