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Regulating Software As A Medical Device Will Take Paradigm Shift, Former FDA Chief Counsel Says

 
• By Hannah Daniel

Sidley Austin partner and former FDA Chief Counsel Jeff Senger told Medtech Insight that the FDA’s software pre-certification program will need to clear manufacturers, as well as software itself.

• Source: Shutterstock

Evidence is mounting that keeping up with software used as medical devices (SaMD) will require assessing manufacturers as well as their products.

Last month, the US Food and Drug Administration published a report on the software pre-certification pilot that it had launched in 2017

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• By Brian Bossetta

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MedTech Europe’s Bisazza Urges Action As US Tariffs Jeopardize Critical Global Supply Chains

 
• By Amanda Maxwell

The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.

UK Medtech Regulators Must Ensure Certainty So Businesses Can Plan Their Futures

 
• By Ashley Yeo

With medtech businesses typically managing investment cycles on a three- to five-year basis, local regulatory processes and forward costs of market entry must offer an attractive environment in which companies can plan for growth, says McDermott Will and Emery’s partner and head of healthcare and life sciences, Sharon Lamb. Broad-scale improvements to NICE’s evaluation offerings would similarly enhance the UK’s value to innovators.