FDA Clearance & CE

FDA Clearance in the United States

Entra Health Systems has clearance from the FDA for sale of the MyGlucoHealth meter in the United States.  The device registration number is 510K-K081703.

According to the FDA, Each person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the Act) and does not exceed the limitations of exemptions in .9 of the device classification regulation chapters (e.g., 21 CFR 862.9, 21 CFR 864.9). There is no 510(k) form, however, 21 CFR 807 Subpart E describes requirements for a 510(k) submission. Before marketing a device, each submitter must receive an order, in the form of a letter, from FDA, which finds the device to be substantially equivalent (SE) and states that the device can be marketed in the U.S. This order “clears” the device for commercial distribution.

CE Certification

The MyGlucoHealth Meter received CE Certification in Europe. The device registration number is 21.34.02.1078. CE is the European conformity marking that indicates that the product complies with all relevant European requirements, and that it has been evaluated according to applicable certification procedures.

The CE marking (an acronym for the French “Conformite Europeenne”) certifies that a product has met EU health, safety, and environmental requirements, which ensure consumer safety. Manufacturers in the European Union (EU) and abroad must meet CE marking requirements where applicable in order to market their products in Europe. A manufacturer who has gone through the conformity assessment process, may affix the CE marking to the product.