Practice

Medical Device and Technology Regulatory

Bringing a medical device to market involves addressing a host of issues: regulatory approval, patents, financing, manufacturing, distribution, and more. After your product debuts, the...

Hogan Lovells Publications

Our FDA Medical Device and Technology compliance team receives ISO 13485 auditor certification Medical Device and Technology Alert

Our team of compliance lawyers and regulatory science professionals has over 100 years combined experience working with medical device companies. To complement our extensive real-world,...

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Hogan Lovells Publications

FDA resumes enforcement relating to laboratory developed tests Medical Device & Technology Alert

On April 4, 2019, the U.S. Food and Drug Administration's (FDA or the agency) Office of In Vitro Diagnostics and Radiological Health issued a Warning Letter to Inova Genomics Laboratory in...

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Hogan Lovells Publications

Regulator proposes reducing requirements for radiation-emitting products Medical Device Alert

In a welcome move, on 1 April 2019 the U.S. Food and Drug Administration (FDA) proposed reducing regulatory requirements for a number of radiation-emitting electronic products, including...

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Hogan Lovells Publications

The right legal partner can put young life sciences companies on the path to future success Life Sciences and Health Care Videos

Life sciences’ biggest innovations are often developed by young, first-time entrants to the marketplace. But promising product or not, many of these companies struggle in navigating a ...

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Hogan Lovells Publications

An intelligent approach for regulating medical device AI Medical Device Alert

Hogan Lovells has been at the forefront of advising our clients on the clearance or approval of an increasing number of software as a medical device (SaMD) products and other medical...

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Hogan Lovells Publications

Influencer promo guide: Best practices for drug and device firms

All companies must be mindful of compliance with Federal Trade Commission (FTC) guidelines for influencers and marketers, which require, among other things, that ads and endorsements be...

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