Is your product a combination product?

Combination products are defined in 21 CFR 3.2(e), and more products than ever now fall into this category. Many manufacturers are unaware of that fact that the FDA identifies nine types of combination products. Take a look at the table below to see if your product is a combination product.

Looking to keep your combination product development moving along?

A comprehensive process is needed to make sure your combination product development project finishes on time and on budget. This comprehensive checklist identifies the key phases and work packages to help you stay on track.

Read Our Recent Blogs

Analytical Techniques For Addressing Viral Vector Purification Challenges

When producing gene therapies, circular plasmids containing therapeutic DNA , an outer capsid shell, and proteins required for virus assembly are inserted into host cells. Manufacturers often face difficulties creating consistency in gene therapy produ...

Rapid Microbiologic Methods Aid In The "Race To Release" Challenges Of Cell And Gene Therapy Manufacturing

  Rapid Microbiologic Methods (RMM) is perfectly suited to cell-based manufacturing because it allows scientists to obtain results up to ten times faster than traditional culture-based microbiological analysis techniques and with less produ...

Will The Real Critical Tasks Please Stand Up: How To Develop Your Human Factors Risk Assessment And Evaluate Critical Tasks

Human Factors Engineering (HFE) is a risk-based discipline crucial to validating that a medical product and its user interface is safe and effective for the intended users and use environments. The HFE process aims to optimize the user interface for me...
See More Blogs