Exploring Combination Products Medical Device Assembly: Certifications Requirements and Outsourcing Solutions

LSO offers medical device assembly for combination products.

Combination products have emerged as a rapidly growing category within medical devices, offering many benefits to healthcare and patients alike. Recent estimates suggest that as much as 30% of FDA submissions now pertain to combination products, signaling a significant trend that has prompted establishment of a dedicated department within the FDA.

In this article, we’ll break down the definition of combination products, their potential benefits, and the necessary certifications for handling them, while also highlighting the specialized services they need for successful and reliable production.

What are combination products?

According to the FDA, a combination product can fall into any of the following four categories:

  • Any combination of a drug and a device
  • A biological product and a device
  • A drug and a biological product
  • A combination of a drug, device, and a biological product

Combination products can take the form of a single-entity combination product, co-packaged combination product, or cross-labeled combination product, depending on their composition and intended use.

Benefits of combination products

Combination products have many potential benefits to improve care for patients and enhance efficiencies for healthcare professionals. Some of these include:

Localized treatment

Targeted application of treatment to specific areas.

Reduction in labor and time

Streamed processes and minimized resource requirements.

Reduction in contamination risk

Reduction of potential for contamination during production and use.

Precise dosage control

Accurate and controlled dosage administration.

Certifications for combination product handling

Contract manufacturers engaged in the production of combination products must adhere to specific certifications to meet regulatory standards. When selecting a contract manufacturing organization (CMO) for outsourcing needs, it is important to verify that the CMO possesses the following certifications for combination product handling:

FDA registration

FDA registration is a prerequisite for American manufacturers operating in the U.S. marketplace.

cGMP certification

Compliance with good manufacturing practices safeguards product quality, safety, and environmental standards.

LSO’s comprehensive approach

Life Science Outsourcing (LSO) is an industry leading CMO partner for medical device assembly services, including combination products. We are committed to quality with a Class 100 Cleanroom on-site at our facility, and a controlled and sterile environment for product assembly. LSO holds cGMP compliance, which provides confirmation of adherence to Good Manufacturing Practices. Our featured services include the low-cost and rapid scale-up manufacturing of phase I pharmaceuticals and combination devices.

Combination product specialties offered by LSO:

  • Aseptic transfer for vials and syringes
  • Quality control (QC) testing
  • Compound blending
  • Stability testing
  • Biocompatibility testing
  • Endotoxin testing
  • Packaging and sealing
  • Packaging validation
  • Sterilization validation
  • Fulfillment and distribution (GMP-compliant warehouse controls)



Choosing a reputable partner with the right certifications such as LSO can provide the required compliance and efficient and high-quality production of combination products you need to get to market faster. Contact us today to get started.

Looking for more information on this topic? Read Precision Reagent Packaging Benefits, Types, and the Ramifications of Amplicons.


Interested in discussing your combination product? Contact us today to explore how we can assist!

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