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...

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Hogan Lovells Publications

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

09 October 2019

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

03 October 2019

On 27 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released the draft guidance entitled "Clinical Decision Support Software" (CDS guidance), which updates the...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

03 October 2019

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FDA issues draft guidance on providing regulatory submissions in electronic format Medical Device Alert

26 September 2019

On 26 September 2019 the U.S. Food and Drug Administration (FDA or the agency) published a draft guidance document entitled "Providing Regulatory Submissions for Medical Devices in...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

23 September 2019

On 19 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released the draft guidance document entitled "Safer Technologies Program for Medical Devices" (STeP),...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

17 September 2019

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:
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Key contacts

Janice M. Hogan

Janice M. Hogan

Partner
Philadelphia, Washington, D.C.

Jonathan S. Kahan

Jonathan S. Kahan

Partner
Washington, D.C.

Randy J. Prebula

Randy J. Prebula

Partner
Washington, D.C.




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Useful Links

Individualized therapies and the future of drug regulation The emergence of intelligent systems in health care A directory of our U.S. government and agency experience

Related areas of focus

Adverse Event Reporting Vigilance Reporting Advertising and Promotion Compliance Advisory Panel Preparation Clinical Trials Combination Products, FDA Jurisdictional Issues, FDA Postmarket Compliance Issues In Vitro Diagnostics Medical Device Artificial Intelligence Premarket Review Unique Device Identifiers State Medical Device Distribution and Manufacturer Licensing

Awards and recognitions

2019

Band 1 for Healthcare: Pharmaceutical/Medical Products Regulatory in the District of Columbia

Chambers USA


2018

Highly Recommended for FDA Medical Devices

LMG Life Sciences


2018

Regulatory Firm of the Year

LMG Life Sciences Awards


2018

Ranked second tier for health care and life sciences in the U.S.

The Legal 500


2018

Band 1 for Life Sciences

Chambers Global


2018

Band 1 for Life Sciences

Chambers Europe



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