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 (RFD) 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 (Pre-RFD) process, which will allow them to make decisions earlier in the product development cycle.
Once OCP receives a request for classification or center assignment, the office will respond within 60 days.
The agency notes that the assessment “depends on sponsors providing a complete, clear and detailed product description, which includes the product’s indication for use, its composition/ingredients, and an explanation of how it works.”
Device manufacturers can initiate the Pre-RFD process at any time during product development – even when a company is contemplating whether to develop a specific product or want advice on what configuration to pursue. During this time that sponsors don’t need to recommend a classification for the product or discuss classification of other marketed products, the agency said.
The FDA is in the process of developing draft guidance about the Pre-RFD process, which will provide details on what information sponsors should provide in a Pre-RFD. The agency also will publish a list of product classifications for various types of products.
The UK’s Medicines and Healthcare products Regulatory Agency issued updated guidance on how manufacturers can make decisions on whether their products would fall under a device or a drug pathway.
The updated guidance discusses what the agency terms “borderline products,” including medical devices, biocides, herbal products, machinery and laboratory equipment.
The guidance notes that the claims being made and the mode of action will distinguish which regulatory pathway would apply.
Medical devices fall into one of three different categories, as each type is governed by a different EU directive:
Companies should not assume that if a product is considered a medical device outside the EU that it will be a medical device in the EU as well.
The guidance offers descriptions on products that have recently been reclassified as devices, including ophthalmological products, devices that deliver drug products, drug-coated devices, and sutures and ligatures.
The guidance adds information on stand-alone software and offers an advice form for borderline products.
Read the guidance here: www.fdanews.com/08-12-16-UKguidance.pdf. — Tamra Sami