Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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



This article was originally published in The Gray Sheet

Executive Summary

REP. DINGELL'S MEDICAL DEVICE HEARING DELAYED TO FALL AT EARLIEST, Claudia Beville, a staffer for Rep. John Dingell's (D-Mich.) House Energy and Commerce oversight subcommittee, indicated a March 2 Health Industry Manufacturers Association conference in Washington, D.C. Beville said that the hearing would likely be held about six months after a subcommittee report on FDA's Center for Devices and Radiological Health is released; the report is expected to be issued in March. The hearing had been expected to coincide with the release of the report. However, Beville said that the subcommittee would like to provide the Clinton Administration and new CDRH Director Bruce Burlington a chance to settle in before calling a hearing. "There is so much change going on that it did not really appear to be appropriate to drag in [Burlington] and have him explain the situation when he is trying to get his feet wet," Beville said. The subcommittee report is expected to focus principally on CDRH's office of device evaluation. The subcommittee has been evaluating ODE for over a year, and the report is likely to describe observed weaknesses in the review program, as well as recommendations for improvements. Beville foreshadowed findings of the report at the HIMA meeting, as she has at other recent public appearances ("The Gray Sheet" Feb. 8, p. 5). For example, commenting on the reasons behind ODE's 510(k) backlog, Beville said that "confusing and contradicting messages" are being given to device reviewers. "They are told they are supposed to take science up a notch, but my opinion is they have not been given adequate information on how to incorporate the increased science operationally into the approval process." However, she added that she was glad to hear that CDRH was considering addressing the "crisis of competence among ODE reviewers" by sending them to continuing education programs outside the agency. She added that the subcommittee had found that reviewers "are demoralized by a multitude of factors, including pressure from industry, pressure from the public, pressure from Congress, [and] pressure from their supervisors." At the same time, they have "been told by the commissioner's office that they need not worry about any [approval decision] time limit for making a decision on an application" and that "the commissioner's office will 'take the heat'" for any review delays. Beville also expressed uncertainty over "how seriously the commissioner's office wants to address this backlog issue." She worried that the commissioner's office will use the backlog "to justify user fees" for the device industry. Despite these concerns, Beville acknowledged that CDRH currently is considering several initiatives aimed at improving the efficiency of ODE. In addition to potentially sending reviewers to more educational seminars, the device center has demonstrated an openness "to at least consider the idea of exempting devices that are not critical or have very low risk" from 510(k) requirements or "providing an alternative way of approval without [the application] going through an extensive approval process," Beville said. She called for 510(k) exemptions for Class I and low-risk Class II devices at the Utah International Medical Device Congress in February. Beville also told the HIMA participants that there is "more willingness [at ODE] to adopt the idea of screening applications before filing, kicking back [to manufacturers] incomplete or unacceptable applications." ODE also is receptive "to the idea of developing guidance documents to improve the quality of applications," Beville said. Although the subcommittee's medical device probe currently is focusing on the device review program, it is likely to turn to enforcement issues following completion of the CDRH report, Beville stated. "There are a number of concerns that" the subcommittee has "regarding enforcement activities that are going on both within" CDRH and the Center for Drugs Evaluation and Research. The subcommittee has received "disturbing allegations of unusually harsh -- almost draconian -- actions that the district offices have taken without really an attempted assessment of whether the action was commensurate with the violation," according to Beville. She said a "multitude" of firms have contacted the subcommittee with enforcement complaints.

You may also be interested in...

Tough Investigator And Universal-Coverage Proponent Rep. John Dingell Dead At 92

Former House Energy and Commerce Committee Chairman John Dingell Jr., D-Mich., who was a fierce investigator of federal agencies including US FDA and sponsor of the Affordable Care Act and other legislation impacting the device industry, died at age 92 Thursday at his home in Dearborn, Mich.

‘Entirely New Theory Of Legal Liability’: FTC v. Amazon Is ‘Dark Patterns’ Case To Watch

Amazon’s motion to dismiss is pending in Washington State’s Western District in litigation concerning Prime subscriptions and alleged “dark patterns” used to trick consumers into enrolling and hinder cancellations, according to the US Federal Trade Commission. The case could be instructive for any and all digital marketers at a time of legal uncertainty surrounding the topic.

Lilly’s ‘High Quality’ Donanemab Data Supports Unrestricted Medicare Coverage, Firm Says

As FDA decision on Alzheimer’s product approaches, new paper outlines Lilly’s arguments for unfettered Medicare coverage for donanemab once it is approved.

Latest Headlines
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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