Stay Up-To-Date With Industry Happenings

Our Client Alerts are our way of sharing current regulatory news and insights with our clients and friends of the firm. Our mailing list is huge and many of our Client Alerts are turned into trade press articles upon a media request to do so.

We pride ourselves in not publishing the pablum that everyone else says about a new law, regulation, guidance or regulatory initiative.

We bring to bear our experience, FDA relationships, our constant interface with FDA in meetings, phone calls and email communications to give you "inside baseball" insights into what it all means.

  • Practical Ways That Medical Device Companies Can Lawfully Communicate About Their Products Prior To FDA Clearance

    • Authored by: Mark DuVal
    • Published on: December 14, 2009

    In this Client Alert, we list practical ways medical device companies can lawfully communicate about their products prior to FDA clearance or approval. We encourage you to consider these activities when developing your pre-launch strategy. We hope this Client Alert helps you avoid common pre-product launch legal pitfalls.

    Executive summary

    There are many pre-clearance/approval activities a medical device company can lawfully engage in prior to attaining their 510(k) clearance/approval of a medical device. This Client Alert provides insight into these activities.

The information on our site is not intended to provide specific legal advice.
Helping clients be appropriately aggressive, yet compliant. TM