Biomedical Engineering

Is a basic document that outlines several data sources with links to the data.

Principal federal health research institute includes centers focusing on cancer, drug & alcohol abuse, infectious diseases, mental health, and other conditions,

Gives context to the department by display with organization chart and relevant links.

Presents a table of FDA databases related to medical devices. There are many hyperlinks among the databases.

Helps users identify devices and their product codes that are used in many FDA databases. This database also lists Recognized Consensus Standards and links to the Code of Federal Regulations and the Total Product Life Cycle report which lists problems.

Consists of those national and international standards recognized by FDA which manufacturers can declare conformity to and is part of the information the Center can use to make an appropriate decision regarding the clearance or approval of a submission.

Is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated on a monthly basis.

Is a request for a significant change in components, materials, design, specification, software, color additive, and labeling to an approved premarket application or premarket report. As a pilot program under the CDRH Transparency Initiative, FDA has begun releasing some summary review memos for 180-day PMA supplements relating to design changes. Updated every Sunday.

Medical device manufacturers are required to submit a premarket notification or 510(k) in order to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified so that its safety or effectiveness could be affected. This database of releasable 510(k)s can be searched by 510(k) number, applicant, device name or FDA product code.