Postmarket Regulations Stricter for Devices Than for Drugs

Federal device postmarket authorities are "far more extensive than for prescription drugs," and the FDA and CDRH are using their authorities to maintain continued device safety, Janet Trunzo, vice president of technology and regulatory affairs at AdvaMed, said.

AdvaMed noted that the FDA initially gives manufacturers a chance to voluntarily make appropriate corrections for deficiencies or violations. However, enforcement actions may come if a manufacturer does not correct violations.

Warning letters, seizures and consent decrees are some of the "more aggressive actions" the agency can take to address regulatory noncompliance that may affect device safety, Joseph Levitt, partner at Hogan & Hartson, said. In cases of prosecution, criminal penalties, including prison sentences and civil money penalties, may be sought.

Requirements for user reporting, reporting of removals and corrections, postmarket surveillance studies, mandatory recalls, banned devices, and repairs, replacements or refunds are unique to devices and do not apply to drug manufacturers, he said.

In addition, the FDA may order manufacturers of certain devices to establish tracking systems so they can promptly locate devices — for example, implanted devices — in commercial distribution.