FDA Policy/General

CDRH Surveillance/Enforcement on Promo Efforts

Current CDRH surveillance and enforcement concerns involving promotional or adverting efforts include unapproved devices (no approval, clearance, or exemption), modified devices (formerly legally marketed but with no approval or clearance for modification), and unapproved/uncleared indications or intended uses. Speaking at a Food and Drug Law Institute conference 10/17 in Washington, DC, Office of Compliance regulatory counsel Deborah Wolf (see slide presentation - begins pg.49) said that other top concerns involve:

Specific claims for general indications
Comparative Ccaims
Imbalance of benefit/risk information

To illustrate the Center’s concern, Wolf highlighted a recent case involving an infusion pump and syringe modifications that the agency had not cleared. The company modified the pump in a manner that could significantly affect safety and effectiveness, Wolf said, such as changing the pressure specification range from 13 psi maximum to 15 psi maximum, and changing the flow rate specification range from 1–500 ml/hr to 0.5-2,400 ml/hr, among others.

Wolf said that the original clearance of the device was intended for use in the home setting or hospital environment using any intravenous fluids recommended for use with certain syringes. She said it was not indicated for the delivery of blood or blood products. However, the manufacturer promoted the device for the infusion of prescribed liquid medicines, including Immunoglobulin G, antibiotics, Desferal, pain medications, chemotherapeutics and cardiac medications. “Indicating the device for a different route of administration or for specific medications or classes of medications raises new scientific review questions, as such changes introduce new risks that are not normally associated with the cleared indication,” she told FDLI.

A significant amount of enforcement work is generated through competitor complaints, Wolf said. Complaints can be reported by email (OCMedicalDeviceCo@fda.hhs.gov) or an online form. Complaints should include the specific allegation, the violating firm and address, and a copy of the promotional materials.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome