Specific Guidelines The general guidelines apply to the entire company worldwide and define the basic conditions for developing apps. Business areas and national companies are, however, free to expand on these conditions for the purposes of their own communications strategy. Check whether specific requirements apply to your company’s development of apps. Pharmaceuticals and Consumer Health Pharmaceuticals and Consumer Health In addition to communication approval, you must also complete a Legal/Medical/Regulatory approval (L-M-R process). Please check with your local organization about the details of this process. In either case, contact your local legal department. There are Medical Software Guidelines and the Product-related Communication Compliance Directive (links on the Bayer intranet only). In addition, the US Food and Drug Administration (FDA) has additional requirements for apps that: are intended to be used as an accessory to a regulated medical device transform a mobile platform into a regulated medical device Contact Overview