The U.S. Food and Drug Administration (FDA) has published a new document that offers guidance to companies importing electronic devices into the U.S. that emit radiation.
The guidance covers both nonmedical and medical products, including diagnostic x-ray systems such as fluoroscopy units. The document's goal is to provide specific recommendations that will facilitate the FDA's import entry review process for device manufacturers.
The guidance covers the agency's affirmation of compliance (AoC) codes that vendors can provide at the time of import entry to expedite the import process. By using the proper AoC codes and their appropriate qualifiers, companies can ensure that their shipments won't be held up for further review by the FDA.
More information on the FDA's guidance is available by clicking here.
