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The FDA has published in the Federal Register a request for comments on "Review of Agreements, Guidances, and Practices Specific to Assignment of
Combination Products in Compliance With the Medical Device User Fee and
Modernization Act of 2002." You can read the text here. You can submit electronic comments here.

In short, the FDA has an office of combination products which will use a combination product's primary mode of action (PMOA) to determine which Agency Center will provide regulatory oversight. Most connectivity related products (i.e., software) are classified as a "contrivance" or an accessory to a medical device - in either case, these products fall under the Center for Devices and Radiological Health (CDRH).

For more info, contact:

Suzanne O'Shea, Office of Combination Products (HFG-3)
Food and Drug Administration
15800 Crabbs Branch Way
Suite 200,
Rockville, MD 20855
301-427-1934, FAX: 301-427-1935
e-mail: suzanne.oshea@fda.hhs.gov.