The Clinical Chemistry and Clinical Toxicology Devices Panel met on October 29, 2001, at the Gaithersburg Hilton to provide advice and recommendations to the Agency on the types of data and/or labeling needed in 510(k) submissions for glucose test systems to address problems associated with using blood samples from alternate sites, such as the forearm, upper arm, thigh, calf, or base of the thumb.
FDA identified the concern, explained the expectations of the meeting, provided an overview of FDA's review of these devices, discussed various data presentation formats, and asked the panel to address the following specific issues:
- Types of data necessary to characterize device performance
- Appropriate Labeling
- Regulatory options for current and future applications
- Recommendations on outreach activities
All panelists felt that the FDA's review should include dynamic and steady-state data and provided suggestions and comments on relevant study issues. The panel also felt that strong cautionary labeling was needed unless a particular device did not demonstrate a problem with discordance. Panelists also suggested that labeling recommend fingersticks when feeling hypoglycemic; post-prandial; before driving; before, during, and after exercise; and when very ill or on certain medications.
The panel thought that education of all the stakeholders was of primary importance and encouraged industry and FDA to develop appropriate outreach activities to ensure an informed public and to promote safe and effective use of these devices.
The five sponsors of alternative site sampling devices provided data specific to particular devices and provided suggestions on study and labeling considerations for the Agency to consider.
A variety of comments were also provided during the open public hearing sessions. Healthcare professionals, diabetics, parents of diabetic children, a manufacturer, and an industry association presented data. All comments supported the position that the benefits of alternate site testing outweigh the risks.
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