Hogan Lovells Publications
04 May 2018
On April 27, 2018, the U.S. Food and Drug Administration (FDA or the Agency) released a draft guidance, Multiple Function Device Products: Policy and Considerations, addressing the Agency's ...
Hogan Lovells Publications
03 May 2018
Last week, FDA released updates to its Software Precertification (Pre-Cert) Pilot Program, including release of a working model reflecting the Agency's vision of the pilot and outlining its ...
Sponsorships and Speaking Engagements
02 May 2018
Beth Roberts will moderate the panel "Accelerating Patient Access to Technology" at the Medical Device Manufacturers Association (MDMA) Annual Meeting. The panel will discuss what the...
Webinar
Wednesday, 25 April 2018
6:00 pm CEST / 5:00 pm BST / 12:00 pm EDT / 9:00 am PDT
We will be hosting the next webinar in our Internet of Things series, focusing on connected medical devices.
Hogan Lovells Publications
25 April 2018
With the continued explosion of software and software-controlled medical devices, including the growing use of machine learning and artificial intelligence, the FDA (the Agency) Medical...
Hogan Lovells Publications
20 April 2018
On April 12, 2018, the U.S. Food and Drug Administration (FDA or the Agency) finalized two guidances on the oversight of next generation sequencing (NGS)-based in vitro diagnostic tests....
