To avoid pitfalls in medical device development, especially in the area of records management, it is essential to be aware of and comply with all Food and Drug Administration (FDA) requirements and regulations. The agency directly responsible for overseeing these regulations is the Center for Devices and Radiological Health (CDRH). Among its many responsibilities, the CDRH develops, gathers, and publishes standards for new medical devices twice a year. Being aware of the most current standards can prevent errors due to incorrect or missing information. Pitfalls that often occur during the testing phase can be prevented by complying with established protocols and industry standards, as well as scrupulous oversight of safety and quality control issues. Internal and external audits of procedures, protocols, and records maintenance can not only insure the integrity of device testing, but also make later reports and presentations for FDA notification or approval simpler and more streamlined. The regulations governing a medical device under development are determined by its FDA classification. Each class of device requires specific handling by the FDA before it can proceed to market. Class I devices are not subject to pre-market notification requirements, while Class II devices require submission of such notification.  Class III devices typically require an FDA Product Approval investigation. Once a medical device is ready for the FDA approval process, intense preparation for an FDA inspection is essential to avoid pitfalls. Improperly completed paperwork, inadequate oversight, and an inconsistent presentation can cause delays in approval and even rejection of the product being presented. The FDA offers online assistance with navigating its medical device regulations and requirements in a collection of electronic material called “Device Advice.” Information about regulations, how to market a medical device, and compliance activities, along with a wide variety of other critical issues, can be found at fda.gov under “Comprehensive Regulatory Assistance” in the “Medical Device” area. This compilation of specific and complete answers to questions regarding medical device testing and records management can help developers, testers, and marketers avoid potential problems during the entire process. If further questions arise after an FDA inspection, an ombudsman is available to respond to inquiries. Having incomplete or missing records, certifications, licenses, or reports can present problems if not handled properly. In addition to FDA requirements and regulations regarding the development, testing, and marketing of medical devices .each U.S. state also has its own regulations mirroring or reaching beyond the federal mandate. This is especially true if testing involves human participants. For example, several states require special handling of high-risk populations, such as developmentally disabled adults or the elderly. International laws may also apply to certain areas of testing and records management. Any misstep along the way can result in unnecessary delays in bringing a successful medical device to market. Because proper, complete, and accurate testing and records management can seem like an overwhelming task, medical device developers often turn to a contract research organization (CRO) for assistance. CROs are specially designed to smooth the way for proper testing and records management. CROs were originally established to address just such issues, but today they provide the gamut of research needs, e.g., the operational aspects of preclinical and clinical medical device testing trials, safety and quality control, data management, and statistical analyses. To avoid pitfalls that can result in a product receiving a negative response from the FDA, a CRO can assist a development team by carrying out or overseeing the completion of all forms and reports mandated by federal, state, and, in some cases, international regulations and requirements, as well as the adherence to scientific protocols and industry standards.