Industry Optimistic About Second CDS Draft Guidance; FDA Releases More Final Software Guidances
After strong pushback to a clinical decision support (CDS) software draft guidance, it seems the US agency has decided to heed industry concerns to take a more risk-based approach by issuing another draft of the guidance. Industry sources are applauding the FDA's move, saying it gives them another opportunity to fine-tune the regulations, which could mean fewer CDS manufacturers would be regulated by the agency.
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The US agency’s device center on 26 October published its A and B lists of guidance documents it will prioritize in fiscal year 2022, including drafting guidances to transition emergency use authorized products to full marketing status, and finalizing a clinical decision support software guidance that’s been four years in the making.
In an interview with Medtech Insight, two Ernst & Young health care leaders outline five trends for medtech companies to redefine their business models in response to COVID-19.
For health-care providers and medtech manufacturers alike, the decade ahead will require a coming to terms with digital technologies and integrating new methods of payment. Quality of service delivery remains the market-entry criterion, but companies will have to adapt to evolving health-care models. The stakes are high. Will manufacturers be able to capitalize on the changes in a market that is more competitive and unpredictable than ever?