Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
The meeting will be held on March 29 and 30, 2018, from 8 a.m. to 6 p.m.
Hilton Washington DC North/Gaithersburg; Salons A, B, C, and D; 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's telephone number is 301–977–8900. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at:
Patricio Garcia, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G610, Silver Spring, MD 20993,
The Eversense CGM System measures patients' glucose concentrations from subcutaneous interstitial fluid similar to approved CGM systems. All CGM devices currently or previously marketed used electrochemistry to measure glucose in interstitial fluids, last for 3 to 11 days and are inserted via a small-gauge needle by the end user. The proposed CGM system uses a fluorescence-based measurement technique, requires minor surgery for subcutaneous implantation, and will have a 90-day sensor wear period. The proposed CGM sensor also includes a drug component (dexamethasone acetate) intended to mitigate negative effects on sensor accuracy and sensor life from the foreign body response at the sensor insertion site. The proposed intended use, as stated by the sponsor, is as follows:
The Eversense CGM System continually measures glucose levels in adults (age 18 and older) with diabetes for the operating life of the sensor.
The system is intended to:
• Aid in the management of diabetes.
• Provide real-time glucose readings.
• Provide glucose trend information.
• Provide alerts for the detection and prediction of episodes of low blood glucose (hypoglycemia) and high blood glucose (hyperglycemia).
The system is a prescription device. Historical data from the system can be interpreted to aid in providing therapy adjustments. These adjustments should be based on patterns seen over time.
On March 30, 2018, the committee will discuss and make recommendations regarding measuring blood glucose using capillary blood with blood glucose meters in all hospital patients, including those receiving intensive medical intervention/therapy and patients with decreased peripheral blood flow, such as with severe hypotension, shock, hyperosmolar-hyperglycemia and severe dehydration (
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's website after the meeting. Background material is available at
Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact AnnMarie Williams, at
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).