In response to Cathy Liles post:

Most Breastfeeding Devices come under the jurisdiction of the FDA. There are
many types of review processes that the FDA uses.

The most common for this class of devices is the 510K (no not similiar to the
401K) Very simply,  this classification just allows a company to say that their
device
is similiar to another product that is already being marketed and sold. The FDA
does review this application and finds that the new device is substanitally
equivalent to another product and allows that company to market the device. This
process can take anywhere from 4 months to several years as there is dialogue
between the coampany and the FDA.

The 510K letter points out that the company should not say that the FDA approves
this device, just that it meets the regualtions of the FDA and can be marketed.

The approval process, such as for new drugs is very expensive. It can cost
hundreds of thousands or millions of dollars for a device or drug to get
approval.


Richard Weston
Medela Inc.