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.
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
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
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).
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
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
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