Medical Device IFU & Labeling for US Market Entry (FDA 510(k))

2026.10.30

For a medical device, the manual itself can hold up market entry. In regulatory terms the user manual is the IFU (Instructions for Use) – a core document tied directly to product clearance, labeling, and usability evaluation, and one of the most common reasons an FDA 510(k) submission stalls. This second installment of our Manuals Under Regulatory Scrutiny series maps the IFU and labeling requirements that medical device manufacturers most often run into when pursuing FDA 510(k), Health Canada, and MDSAP, and explains why regulatory strategy and document production must be managed together.

What Information Does the FDA Expect in Your IFU?

2026.10.30

A Practical Guide to Preparing Instructions for Use (IFU) for U.S. Medical Device Marketing Authorization