Publications

Hogan Lovells Publications

Harmonizing cybersecurity for medical devices: International collaboration moves forward Medical Device Alert

On 1 October 2019 the International Medical Device Regulators Forum (IMDRF) Medical Device Cybersecurity Working Group released a draft document titled "Principles and Practices for Medical ...

Hogan Lovells Publications

Clarifying clinical decision support: FDA overhauls guidance to focus on risk Medical Device Alert

On 27 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released the draft guidance entitled "Clinical Decision Support Software" (CDS guidance), which updates the...

Hogan Lovells Publications

Guidances galore: FDA finalizes multiple digital health guidance documents Medical Device Alert

On 27 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released a series of guidance documents addressing the agency's current views on software regulation following ...

Hogan Lovells Publications

FDA issues draft guidance on providing regulatory submissions in electronic format Medical Device Alert

On 26 September 2019 the U.S. Food and Drug Administration (FDA or the agency) published a draft guidance document entitled "Providing Regulatory Submissions for Medical Devices in...

Hogan Lovells Publications

Final guidance provides additional clarity to the Humanitarian Device Exemption program Medical Device Alert

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 Medical Device Alert

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 Medical Device Alert

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 Health Alert

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 Medical Device Alert

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."

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