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Although FDA and CMS regulate different aspects of health care—FDA regulates the marketing and use of medical products, whereas CMS regulates reimbursement for healthcare products and services for two of the largest healthcare programs in the country (Medicare and Medicaid)—both agencies share a critical interest in ...

FOOD AND DRUG ADMINISTRATION. AND CENTERS FOR MEDICARE & MEDICAID SERVICES.

The FDA has broad legal authority to regulate many classes of drugs and medical devices (including in vitro diagnostics). However, the regulatory authority for lab-developed tests resides with CMS. FDA regulates these classes of drugs through standards defined as 21CFR.

The Catalog of Regulatory Science Tools provides a peer-reviewed resource for medical device companies to use where standards and qualified Medical Device Development Tools (MDDTs) do not yet exist. These tools do not replace FDA-recognized standards or MDDTs.

The FDA ensures our safety by regulating our food and medication. The CMS provides information on insurances, including Medicaid and Medicare, and state and federal health insurance marketplaces. The FDA influences my nursing practice by regulating the medications I administer to my patients.

The FDA's Medical Device Development Tools (MDDT) program is intended to facilitate device development, timely evaluation of medical devices, and promote innovation by providing a more efficient and predictable means for collecting the necessary information to support regulatory submissions and associated decision- ...

In 2011, the FDA and CMS introduced the Parallel Review Pilot Program (Parallel Review), which established a mechanism for the FDA and CMS to simultaneously review the pivotal clinical data to help decrease the time between the FDA's approval of a premarket application and the subsequent CMS national coverage ...

Within FDA, the Center for Devices and Radiological Health (CDRH) is responsible for ensuring the safety and effectiveness of medical devices and eliminating unnecessary exposure to radiation-emitting products.