Regulatory and Reimbursement Resources
American Medical Association CPT Code/Value Search
Free for patients and consumers, this site allows users to search CPT codes and their relative values.
Bureau of Labor Statistics (BLS)
Visit the BLS website, part of the U.S. Department of Labor, for statistical information relating to labor market activity, working conditions and economic price changes.
Centers for Disease Control and Prevention (CDC)
Search through the official CDC website for reliable health information and statistics.
Centers for Medicare and Medicaid Services (CMS)
From the U.S. Department of Health and Human Services, the CMS includes all official information related to Medicaid and Medicare.
Clinical Trials
ClinicalTrials.gov provides a registry of federally and privately supported clinical trials. It includes information about the purpose, participants and locations of a trial, as well as phone numbers for more details.
Export Licensing
Find information about the export licensing process and determine what you should know before exporting your product(s). Information includes export licenses for embargoed countries, as well as to non-embargoed countries where the medical
FDA: 510(k) Pre-market Notification
Updated monthly, the FDA 501(k) database is searchable by 501(k) number, applicant or device name, decision date and additional parameters. This database of new or significantly changed device information is submitted by medical device
FDA: Approvals
Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers to notify the FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification (PMN) or 510(k).
FDA: Center for Drug Evaluation and Research
Find news, announcements and additional information about drug evaluations and research from the U.S. Food and Drug Administration.
FDA: Database Listing
Search from a list of FDA database listings for medical device regulations and guidance
FDA: Manufacturer and User Facility Device Experience (MAUDE) Database
Search this database from the Department of Health and Human Services for problems or adverse events related to medical devices.
FDA: Medical Devices
The U.S. Health and Human Services website is dedicated to the regulatory and the safety of medical device practice.
FedStats
Find official statistical information produced by the federal government by searching this website. It links to more than 100 agencies that provide data and trend information on a variety of topics.
Fee Schedules: Center for Medicare and Medicaid Services
Download comprehensive Medicare fee schedules and related information from the Center for Medicare and Medicaid Services.
Freedom of Information Act Online
The Freedom of Informtion Action Online maintains a private library of more than 150,000 FDA documents in all categories of products regulated by the agency. It also includes a DocuSearch® system that can easily determine if the document
Healthcare Cost and Utilization Project (HCUP)
This website includes healthcare databases and software tools sponsored by the Agency for Healthcare Research and Quality (AHRQ). The HCUP databases contains data collected from state data organizations, hospital associations, private
Musculoskeletal Clinical Regulatory Advisers
MCRA’s regulatory department guides orthopaedic technologies through FDA approval at any point of the device life-cycle from pre-clinical testing to FDA submission, market approval, and post-commercialization. MCRA’s
National Center for Health Statistics
Part of the Center for Disease Control, the National Center for Health Statistics’ website includes statistical information about health in the U.S.
National Institutes of Health (NIH)
Part of the U.S. Department of Health and Human Services, the NIH is the United States’ medical research agency. It makes medical discoveries that improve health and save lives.
Neocure
The Neocure Group helps medical technology innovators achieve commercial success. We develop reimbursement, health economics and regulatory strategies that deliver measurable business outcomes.
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