From:: iMedicalApps
While the FDA has softened its approach to regulating mobile medical apps, developers should be aware of the fact that some apps will still require agency approval. To be prepared for that possibility, designers need to first understand the three-tiered approach that FDA uses to classify risk during the medical device approval process. Class I devices rarely require FDA authorization before they can be put on the market. These devices present minimal potential to do harm to the public and include items like elastic bandages and enema kits. Ninety five percent of these devices are exempt from the regulatory process according to the FDA.
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