Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Postmarket Device Surveillance Reforms Raised At Califf Confirmation Hearing

This article was originally published in The Gray Sheet

Executive Summary

Robert Califf responded to questions about improving postmarket device surveillance during his Nov. 17 confirmation hearing, including from HELP Committee Ranking Member Patty Murray, D-Wash., who raised the issue in relation to tainted duodenscopes that led to the deaths of several people in her state. Califf also addressed questions on lab-developed test oversight and charges that FDA overuses guidance documents.

You may also be interested in...

Commissioner Califf: Cardiologist, Clinical Trials Expert Ascends At FDA

The Senate confirmed Robert Califf as the new FDA commissioner after months of delay, giving the cardiologist, clinical trial expert and established agency official a better platform to push his priorities, which include combination product and clinical data-collection reforms, while implementing projects already under way.

Scope Firms, FDA Faulted In 300-Page Senate Report Seeking Device Reforms

Senate HELP Ranking Member Sen. Patty Murray in a staff report criticizes FDA and manufacturers for reacting slowly to duodenoscope contamination incidents in 2013. The report says FDA needs a more robust device surveillance system and calls for more attention to 510(k) modification policies. Murray is a key partner in ongoing Senate work to produce a so-called "medical innovation" bill.

Califf Expected To Ace Senate Panel Vote, As He Ups Emphasis On Safety Surveillance

The Senate Health, Education, Labor and Pensions Committee plans a confirmation vote on Robert Califf Jan. 12 to become the next FDA commissioner. Public health researchers and Sens. Sanders and Warren have argued that the long-time academic research leader's ties to industry are too close. Meanwhile, Califf recently has emphasized his focus on strengthening postmarket safety oversight.

Related Content





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts