FDA May Develop Nanotech GuidanceFDA May Develop Nanotech Guidance

An FDA task force on nanotechnology does not see a need at this time to add more regulations regarding use of nanotechnology in medical devices, but its report recommends that the agency consider developing guidance. It emphasizes that there is a need for ensuring transparent, consistent, and predictable regulatory pathways. Specifically, the task force would like to see guidance that would clarify what information to give FDA about products, and when the use of nanoscale materials may change the regulatory status of particular products. This is the prudent and correct response. At last year's public meeting of the task force, some consumer groups wanted a ban on the use of nanotechnology in FDA-regulated products until more research could be done, or for there to be more regulations controlling nanotechnology's use. But in the case of devices, the PMA and 510(k) processes already require information about what a device is made of, so FDA already has the authority to make device companies perform toxicology and other tests and provide data showing nanomaterials are safe. What industry needs is clarification about how this process should work, not a new process. And that's what the guidances are for.