Wow!  My last post
really piqued your interest.  Thanks to
everyone for well over 100 comments posted and many more conveyed through
email.  I have read through all of them
and there are some great ideas and questions in there.  Because of the interest and because we are
going to be asking our advocates to increasingly get involved in regulatory
issues, this post is going to give you a brief overview of the regulatory
system in the U.S., focusing on medical devices.

FDA is organized into Centers that have responsibility for
specific types of food and medical products. 
Three Centers have involvement with diabetes products:

Center for Drugs Evaluation and Research (CDER)

• Insulin
• Drugs
  to treat complications (e.g., eye therapies)

Center for Biologics Evaluation and Research (CBER)

• Islet
  transplantation
• Immune
  therapy

Center for Devices and Radiological Health (CDRH)

• Insulin
  pumps
• Continuous
  glucose monitors (CGM)
• Self-monitoring
  blood glucose (SMBG) meters
• Artificial
  pancreas

Within CDRH, one unit has responsibility for insulin pumps
and artificial pancreas systems while another oversees SMBG meters and CGMs. 

FDA uses a three-tiered classification system to regulate
medical devices: class I devices are simple products and have lowest amount of
regulation (e.g., bandaids) and class III devices are complex products that
have the highest degree of regulation (e.g., heart valve).

Insulin pumps and SMBG meters are class II devices.  This means that a manufacturer has to get a
clearance through FDA before they can sell the device to patients.  To do this, they submit what is known as a
Premarket Notification, or 510(k) application, to FDA that includes data and
information showing that the new device is very similar to a device already on
the market.  A 510(k) usually includes
laboratory data and sometimes also includes clinical data.

CGMs are class III devices as are artificial pancreas
systems.  Manufacturers must submit a
Premarket Approval (PMA) application and get approval before being able to make
these available to patients.  A PMA must
show the device is safe and effective through laboratory data as well as data
from at least one clinical study.

So, that’s the basics. 
There is a lot more I could cover if there is interest, so let me know
if this is helpful and if you’d like to see more in the comments below.

And, don’t forget to tune into Aaron Kowalski’s webcast
about the Artificial Pancreas Project in a week – March 8 at 1pm
EST.