FDA's strengthening initiatives...
Public Meeting: Strengthening the Center for Devices and Radiological Health's 510(k) Review Process, February 18, 2010

The CDRH must determine your device is substantially equivalent (or meets the comparison of being substantial l equivalence to a valid predicate device) before you may offer your device for sale in the US.


Federal Register Notice. FDA has published a notice in the Federal Register announcing a public meeting on February 18, 2010, and requesting comments on a number of questions regarding actions that the Center for Devices and Radiological Health (CDRH) could consider taking to strengthen the premarket notification process for review of medical devices, also known as the 510(k) process.


Dr. William H. Maisel, Director
Office of Device Evaluation
U.S. Food and Drug
Administration Center for Devices and Radiological Health
Office of Device Evaluation
10903 New Hampshire Avenue
WO66-1676
Silver Spring, MD 20993-0002

Program Operations Staff
Phone: 301-796-5640

Premarket Approval Section
Phone: 301-796-5640


Investigational Device Exemption, 301-796-5640
Premarket Notification (510(k), 301-796-5640
Regulations Staff, 301-796-5690
Compliance, 301-796-5500
Program Management, 301-796-5500
Bioresearch Monitoring, 301-796-5490
Risk Management 301-796-5530
Registration & Listing 301-796-7400
Export Certificates 301-796-7400
Infection Control / Dental Devices, 301-796-5580
Cardiovascular Devices, 301-796-7000
Surgical, Orthopedic, 301-796-5650
Restorative Devices 301-796-5650
Ophthalmic, Neurological, 301-796-5620
ENT Devices 301-796-5620
Reproductive, Gastro-Renal, 301-796-6650
Urological Devices, 301-796-6650
Enforcement A, 301-796-5770
Enforcement B, 301-796-5540

510(k) Clearances

Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k). This allows the FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. Such change or modification could relate to the design, material, chemical composition, energy source, manufacturing process or intended use.