Publications

Hogan Lovells Publications

Final guidance provides additional clarity to the Humanitarian Device Exemption program

On 6 September 2019 the U.S. Food and Drug Administration (FDA or the agency) issued its final guidance document entitled "Humanitarian Device Exemption (HDE) Program."

Hogan Lovells Publications

De Novo requests: FDA releases updated RTA checklist

On 9 September 2019 the U.S. Food and Drug Administration (FDA or the agency) issued its final guidance document entitled "Acceptance Review for De Novo Classification Requests."

Hogan Lovells Publications

Uncertainty remains: FDA releases new benefit-risk decision tree for medical device PMAs and De Novos in concert with final uncertainty guidance

On 30 August 2019 the U.S. Food and Drug Administration (FDA or the agency) issued a final guidance document entitled "Consideration of Uncertainty in Making Benefit-Risk Determinations in...

Hogan Lovells Publications

A bit more Sunshine: CMS proposes collecting additional information on manufacturer payments under the Open Payments program

Device and drug manufacturers got a small surprise in the annual Physician Fee Schedule proposed rule (at 40,713-16) issued late in July by the Centers for Medicare & Medicaid Services...

Hogan Lovells Publications

New draft guidance on MR compatibility for medical devices

The U.S. Food and Drug Administration (FDA) has published a new draft guidance titled "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment."

Hogan Lovells Publications

HHS announces public meeting on ways to accelerate clinical innovation

Government seeks industry comment on expediting medical product development

Hogan Lovells Publications

U.S. Supreme Court rules judges must decide whether preemption applies, and clarifies when it does

Opinion highlights importance of a "clear" record at FDA

Hogan Lovells Publications

FDA resumes enforcement relating to laboratory developed tests

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...

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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