Ropes & Gray Publishes U.S. Medical Device Recalls Resource Manual, a Reference Tool to Guide Medical Device Companies

Ropes & Gray has published a U.S. Medical Device Recalls Resource Manual, a reference tool for medical device companies, considering, planning, or executing product recalls and other field actions.

The manual begins with a preface and handy visual aids describing key recall considerations, including how to make risk‑based recall decisions, how to be recall-ready, and how to prepare recall communications. The remainder of the nearly 600-page manual is a compilation of relevant statutory provisions and Food & Drug Administration (FDA) regulations, guidance documents, manuals, and training materials related to medical device recalls. Many of these FDA statements are hard to find, or previously not been compiled in one place. The manual consolidates these key sources of FDA guidance in one spot for easy reference.

The authors note there is no specific U.S. law or regulation that tells manufacturers or distributors exactly when they must recall a device, but once a manufacturer knows that a device it sold or distributed is, in some respect, defective or otherwise in violation of the law, it has to grapple with the decision of whether to leave that product on the market in its current form. The manual addresses considerations that a company needs to take into account in making this kind of judgment.

The manual was authored by life sciences regulatory and compliance partners Greg Levine and Joshua Oyster.

To receive the manual, send an email to devicerecallsmanual@ropesgray.com.