Class I: General Controls

As we all know, there three classifications of medical devices and each classification depends on the risk that a medical device may bring. Class I is regulated with the least regulatory control and is subjected to general controls of the Food and Drug Administration. The scope of the general control set by the Food and Drug Administration includes:

1. Establishment Registration by manufacturers, distributors, repackages and re-labelers
2. Medical Device Listing with FDA of devices to be marketed
3. Manufacturing the devices in accordance with Good Manufacturing Practices
4. Labeling medical devices in accordance with the labeling regulations, 21 CFR 801 or 21 CFR 809
5. Medical Device Reporting of adverse events as identified by the user, manufacturer and/or distributor of the medical device

Though class I medical devices has the least amount of regulatory control, there is still a need for you to consult a medical device regulatory consultants. They are the right people to consult because they exactly know what to do.

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