Regulatory Resources

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 manufacturers prior to commercial distribution.

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).

Find news, announcements and additional information about drug evaluations and research from the U.S. Food and Drug Administration.

Search from a list of FDA database listings for medical device regulations and guidance

Search this database from the Department of Health and Human Services for problems or adverse events related to medical devices.

The U.S. Health and Human Services website is dedicated to the regulatory and the safety of medical device practice.

The Freedom of Information 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 is available to order.

Part of the Center for Disease Control, the National Center for Health Statistics’ website includes statistical information about health in the U.S.

Updated monthly, this database includes all PMAs, private licenses for marketing a medical device, approved by the FDA. Search the database by applicant name, trade name, docket number and additional parameters.

TrialMed is an organization that focuses on early start-up and mature companies that need clinical, regulatory and marketing expertise, low cost medical animation in the life science industry. We also help innovators find the shortest and most logical regulatory and clinical path for their products success and commercialization. Starting with the proof of concept clinical […]

Visit the website for the U.S. Food and Drug Association for a wealth of information about the safety and security of drugs, biological products, medical devices, our food supply, cosmetics and more.

A trustworthy medical device resource with news, directories and more.