Area of focus

Advisory Panel Preparation

You’ve spent many years developing and testing your product to bring it to market. A make-or-break step in this process can be securing a positive recommendation from the relevant U.S. Food and Drug Administration (FDA) advisory panel. To achieve that goal, preparation is essential.

Having assisted numerous companies ...

Representative experience

Despite client’s 2 non-approvable letters before our work, we helped with PMA amendments & secured unanimous Advisory Panel approval recommendation.

Ran PMA & Advisory Panel process & gained approval for novel, non-invasive screening test using advanced DNA technology detecting colorectal cancer.

Managed PMA & Advisory Panel Process & facilitated approval for novel tissue glue product that removes need for abdominoplasty post-surgical drains.

Hogan Lovells Publications

Navigating the U.S. FDA regulatory clearance for digital medical devices: the 510(k) and Pre-Cert program

Consumer demand for digital health care devices has soared, and it shows no signs of slowing down. But when bringing these devices to market, companies in the digital health space are...

Quick view Full view

Hogan Lovells Publications

What device companies need to know ahead of an advisory panel meeting Hogan Lovells Publications

Preparing for advisory panel meetings For companies that manufacture new and novel medical devices, advisory panel meetings can be a crucial step toward receiving formal clearance or...

Quick view Full view

Hogan Lovells Publications

New FDA final guidance on medical device panel meetings provides certain changes to timelines and procedures Medical Device Alert

On September 1, 2017, the Food and Drug Administration (FDA or the Agency) released a final guidance document discussing the procedures for Medical Device Advisory Committee meetings (or,...

Quick view Full view


The FDA Advisory Panel Meeting: Ensuring Success in an Unpredictable Process

How do you raise the likelihood of success of your FDA Medical Device Advisory Panel meeting?

Quick view Full view
Loading data