The FDA has sent a warning letter to Medtronic's surgical navigation tools business that states the unit has failed to establish and maintain procedures for certain issues such as validating device design and checking complaints. The May 7 letter was disclosed Tuesday.
In its letter, the agency says during a Jan. 2 - Feb 4 inspection, an FDA investigator determined the company, among other things, "failed to establish and maintain procedures for implementing corrective and preventive action, including investigating the cause of nonconformities relating to product, processes and the quality system." In addition, the company hadn't established procedures for receiving, reviewing and evaluating complaints by a "formally designated unit."
This is one of three active warning letters for the company, which has talked recently about how the FDA has stepped up oversight efforts, Dow Jones notes. Indeed, the FDA disclosure of the letter came the same day as a Wall Street Journal interview with CDRH head Jeffrey Shuren. In the interview, Shuren says he is trying to create a clearer sense of direction, and that changes to the 510(k) approval process could come this year.
The WSJ article notes that industry views the FDA as becoming tougher and less predictable. Medtronic CEO Bill Hawkins, for example, said during a May conference call that "I think you'd have to make the assumption that there is more risk now with the FDA." That may mean it takes more time to resolve so-called warning letters, which the agency can hand out when it finds problems at company facilities, he said.
Medtronic shares traded five cents lower to $35.98 late Tuesday.
- read the warning letter
- get more from Dow Jones
- read the Shuren interview