The FDA has issued final guidance clarifying exactly when manufacturers must have the agency review device modifications. The new guidance documents essentially reiterate a message that the FDA has been sending to manufacturers for several years. In most cases, changes made to medical devices – or to the software – to address the security of the products do not require FDA review via the “510(k) submission” process. The guidance is directed primarily at vendors, but the documents are potentially helpful to healthcare providers as well, expert says.”]