The FDA released 3 additional draft guidances to close out 2011, bringing its total to 9 guidances for the year.
The new drafts outline the agency’s protocol for medical device product codes, detail the process for appealing a decision made by the Centers for Devices & Radiological Health, and provide advice on how a drug or device maker should handle requests for information on off-label use for products,
The first guidance covers medical device product codes. The CDRH develops and manages codes to identify and track devices and allow for easy tracking of and reference to predicate devices. The codes stick with a device through its regulatory life cycle at the FDA.
The purpose of the guidance is to "how, when, and why to use classification product codes for medical devices in a variety of FDA program areas to regulate and track medical devices," according to the document.
The second draft guidance covers the appeal process for device makers that wishing to contest CDRH decisions by requesting additional review.
The document aims to describe the various routes a manufacturer can take, including requests for supervisory review, petitions and hearings. When finalized, the guidance will replace protocols implemented in 1998 and 2001.
Finally, the third guidance provides advice on how drug and device manufacturers should respond to unsolicited requests for information on off-label use for their products.
By law, medical device makers aren’t allowed to market products for uses other than what the FDA has granted clearance for, but physicians can legally use prescribe or use the products in ways that aren’t included on the label.
"FDA recognizes that these off-label uses or treatment regimens may be important therapeutic options and may even constitute a medically recognized standard of care," according to the guidance.
The watchdog agency noted that online communications, especially in the form of publicly visible forums or chat rooms, may cross over into communication that FDA often considers evidence of off-label marketing, a no-no for industry.
In the new guidance, the FDA promises not to slap device makers with an off-label use warning as long as they comply with the agency’s rules, which include providing the off-label information only to the specific individual making the request in a private, one-on-one communication.