Publications

Hogan Lovells Publications

"Make in India" initiative extends to medical devices - India's new medical device rules are now in effect

In January 2017, India's Ministry of Health and Family Welfare released the long-awaited Medical Device Rules of 2017 (MDR 2017 or the Act), which took effect on January 1, 2018. Upon...

Published Works

Filling in the gaps on medical device cybersecurity - Privacy & cybersecurity law report

The Food and Drug Administration (FDA), in collaboration with the National Science Foundation (NSF) and the Department of Homeland Security (DHS) Science and Technology...

Hogan Lovells Publications

Filling in the Gaps on Medical Device Cybersecurity

Cybersecurity has become a hot button topic for many in the medical device industry following the announcement of several high-profile medical device vulnerabilities and in light of the...

Published Works

Antimicrobial resistance concerns leach into FDA's classification of wound dressings containing drugs

On September 20–21, 2016, FDA convened an advisory panel to seek recommendations about the regulatory classification for wound dressings containing drugs. These devices are widely...

Publications

FDA Tries Again to Settle Classification of Wound Dressings With Drugs

On September 20 and 21, 2016, FDA convened an Advisory Panel to obtain recommendations regarding the appropriate regulatory classification for wound dressings containing drugs. Such devices ...

Hogan Lovells Publications

FDA Releases New Draft Guidance Document on 3D Printing of Medical Devices

Additive Manufacturing (AM), commonly known as 3D printing, is increasingly being used in the manufacture of medical devices, including orthopedic and cranial implants, surgical...

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