Publications

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On 27 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released the draft guidance entitled "Clinical Decision Support Software" (CDS guidance), which updates the...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

FDA issues draft guidance on providing regulatory submissions in electronic format Medical Device Alert

On 26 September 2019 the U.S. Food and Drug Administration (FDA or the agency) published a draft guidance document entitled "Providing Regulatory Submissions for Medical Devices in...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

FDA announces new expedited program for devices expected to significantly improve the safety of existing technologies Medical Device Alert

On 19 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released the draft guidance document entitled "Safer Technologies Program for Medical Devices" (STeP),...

Hogan Lovells Publications

FDA releases four final guidances on the 510(k) program; Special 510(k) guidance confirms new approach to eligibility and broader potential for IVDs Medical Device Alert

On 13 September 2019 the U.S. Food and Drug Administration (FDA or the agency) published four final guidance documents on the 510(k) program:

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

CDRH issues final rule on appeals, excluding De Novos from 517A Medical Device Alert

On 2 July 2019 the U.S. Food and Drug Administration (FDA) issued a final rule finalizing the category of "517A decisions," previously termed "significant decisions," as well as two...

Hogan Lovells Publications

In the midst of government shutdown, FDA pushes ahead with 510(k) modernization Medical Device Alert

Thirty-two days into the longest government shutdown in U.S. history, the Food and Drug Administration (FDA or the agency) announced two developments signaling further headway toward...

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