Introduction: It is hoped that 3D printing will achieve a revolution in medical devices in general and orthopedic devices in particular. Three-dimensional printing has the potential to move both the innovation and manufacture of orthopedic devices closer to the hospitals, surgeons, and patients who are the consumers of these devices. Whether this potential of decentralization in production and innovation will actually occur depends, in large part, on the regulatory environment that is evolving. Economic theory: The economic principles of centralized and decentralized production are presented. These principles are extended to innovation, which is the production of ideas. Regulatory environment: The general economic principles of regulation are presented. Regulation mandates minimum standards of product quality. These minimum standards add costs to production. The history of FDA regulation of 3D printing is presented. The FDA regulatory process is evolving from the existing environment for the conventional manufacture of medical devices. The impact of the regulatory process, as it exists in December 2017, on small business is discussed. Conclusions: The impact of 3D printing on orthopedic devices depends in large part on how the FDA manages the regulatory environment moving forward. Regulation will likely be as protective of public safety as the existing regulatory framework. Regulation will likely favor larger enterprises with expertise in navigating the regulatory environment. Startups and smaller enterprises taking advantage of 3D printing technology may have to partner with larger enterprises to take advantage of existing expertise in quality control and assurance.