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...

Events

Sydney: Join leaders from Hogan Lovells Medical Device team for conversation and cocktails

We welcome you to join members of our medical device and health care regulatory team as we discuss how to navigate the shifting regulatory landscape facing medical device firms. From...

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Sponsorships and Speaking Engagements

9th Annual Medical Device Supplier Quality Assurance Conference

Dennis Gucciardo addressed the regulatory clarification on risk assessment within the ISO 13485:2016 framework at the 9th Annual Medical Device Supplier Quality Assurance Conference.

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Hogan Lovells Publications

New FDA draft guidance on voluntary recalls highlights importance of recall initiation plans Focus on Regulation

On 23 April, Food and Drug Administration (FDA) issued draft guidance entitled "Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C," which aims to clarify how firms in a...

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Hogan Lovells Publications

New OMB review process could impede FDA issuance of guidance documents Medical Device Alert

Starting on 11 May 2019 there will be an additional layer of government review that may slow down the issuance of certain U.S. Food and Drug Administration (FDA) guidance documents.

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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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