The agency has reinvented the process for clearing digital health products but reviews are mixed on the emphasis of company ‘excellence’ rather than product evaluations.

Poll: Is the FDA Pre-Cert program an effective way to regulate digital health products?

By MobiHealthNews
FDA sign outside


Since new FDA Commissioner Scott Gottlieb announced the FDA precertification program, the agency has been moving full speed ahead to re-invent its process for clearing digital health products. Pre-Cert will emphasize a focus on evaluating “standards of excellence” for the company or firm, rather than focusing on specific products. The idea is that trusted shops will be able to iterate technologies at their own pace.

While many support the program, critical voices have also begun to emerge. Bradley Merrill Thompson, a member of the firm at Epstein Becker Green who also helps lead the Clinical Decision Support Coalition, laid out some of his own concerns in a recent editorial.

So we’re asking readers what you think.

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