Conformity Assessment Programs
The following are Federal Agency conformity assessment programs. Detailed information about a specific program can be found by clicking on the progam name.
The Standards Management Staff (SMS) is responsible for facilitating the recognition of national and international medical device consensus standards. CDRH is invested in the development of medical device standards and participates significantly in the development process. SMS manages the Standards Program, a regulatory support activity consisting of cross-office teams within CDRH and FDA. This involves working closely with the Standards Developing Organizations (SDOs), advertising standards liaison representative positions, facilitating a Center recommendation to serve on a particular standards activity, and maintaining an appropriate standards database providing access to established standards for all CDRH staff, field inspectors, and industry. SMS continually updates currently recognized standards and coordinates the recognition of new voluntary consensus standards for medical devices and radiation-emitting electronic products. SMS ensures appropriate medical device standards are published in the Federal Register at least twice annually. The Standards Program was created as a result of the Food and Drug Administration Modernization Act (FDAMA) of 1997. Although CDRH had been involved in the development of medical device standards for decades, FDAMA formalized the process.
In December 2008, the Assistant Deputy Under Secretary of Defense (Environment, Safety and Occupational Health) issued a memorandum establishing the DoD Environmental Laboratory Accreditation Program (DoD ELAP), which requires laboratories that perform testing in support of the Defense Environmental Restoration Program to be accredited. DoD ELAP utilizes third party Accreditation Bodies, which must be U.S.-based signatories to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA), to assess laboratories to ISO/IEC 17025:2005 as implemented by the DoD Quality Systems Manual for Environmental Laboratories (DoD QSM).
ENERGY STAR Program
ENERGY STAR is a U.S. Environmental Protection Agency (EPA) voluntary program that helps businesses and individuals save money and protect our climate through superior energy efficiency. All products, homes, and buildings that carry the ENERGY STAR are third-party certified to ensure they meet EPA's strict specifications.
Federal Risk and Authorization Management Program (FedRAMP)
The Federal Risk and Authorization Management Program (FedRAMP) is a government-wide program that provides a standardized approach to security assessment, authorization, and continuous monitoring for cloud products and services.
GRaDER® (Graduated Radiological/Nuclear Detector Evaluation and Reporting) Program
GRaDER® evaluates commercial off-the-shelf (COTS) Radiological/Nuclear (Rad/Nuc) detection equipment against national consensus standards adopted by the Department of Homeland Security and government unique Technical Capability Standards. The program identifies products that comply with the standards, enabling federal, state, local, tribal, and territorial agencies to make more informed rad/nuc detector procurement decisions.
List of CPSC-Accepted Testing Laboratories
Section 14(a)(3)(E) of the Consumer Product Safety Act, as amended, requires the CPSC to maintain on its website an up-to-date list of entities that have been accredited to assess conformity with children's product safety rules that are enforced by the Commission. The laboratories in the CPSC list have been accepted as accredited to test products to one or more of children's product safety rules, as identified in the accreditation scope for each laboratory. A manufacturer of a children's product that must comply with one or more of these rules must support its certification of compliance with test results from one of these laboratories.
Nationally Recognized Testing Laboratories Program
The Nationally Recognized Testing Laboratory (NRTL) Program recognizes private sector organizations to approve (i.e., test and certify) certain type products to help ensure that they can be used safely in the workplace. OSHA requires NRTL approval for 37 different types of products. Electric equipment is the largest of these product categories. The requirements for NRTL approval apply where these type products are used in workplaces subject to OSHA's jurisdiction. The related certification activities involve the NRTL ensuring that all manufactured units of the product meet the necessary safety specifications. Proper product testing and certification require a great deal of special expertise, effort, and resources. OSHA does not perform any product approvals; OSHA relies on third parties, NRTLs, to do this work.
ONC Health IT Certification Program
The Office of the National Coordinator for Health Information Technology (ONC) Certification Program provides a defined process to ensure that Electronic Health Record (EHR) technologies meet the adopted standards and certification criteria to help providers and hospitals achieve Meaningful Use (MU) objectives and measures established by the Centers for Medicare and Medicaid Services (CMS).
Project 25 Compliance Assessment Program (P25 CAP)
Project 25 (P25) is a standard which enables interoperability among digital two-way land mobile radio communications products used by public safety professionals. P25 CAP is a voluntary program that allows manufacturers to formally demonstrate their products' compliance to P25 standards. P25 CAP provides responders the confidence that the communications equipment they buy will be interoperable, regardless of manufacturer. Compliance testing is a formal, independent process that concludes with official summary test reports and suppliers' declaration of compliance documents. P25 CAP makes test results available to the first response community on the Federal Emergency Management Agency's (FEMA) Responder Knowledge Base (RKB) Web site.
USDA, Agricultural Marketing Service
The U.S. Department of Agriculture's Agricultural Marketing Service administers programs that facilitate the efficient, fair marketing of U.S. agricultural products, including food, fiber, and specialty crops.