FDA, UK Adjust Combination Product Determination Process

FDA officials said the agency will allow earlier interaction with sponsors to determine the regulatory pathway for combination products. In a similar move, the UK issued updated guidance to help sponsors make those determinations.

Previously, devicemakers would submit a Request for Determination to the FDA’s Office of Combination Products to help them make decisions about whether the agency would regulate the combination product as a drug or device.

Manufacturers can now engage FDA officials earlier in the process under a Pre-Request for Designation process, which will allow them to make decisions earlier in the product development cycle. — Tamra Sami