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

UsernamePublicRestriction

DEVICE CENTER REVIEW OF STANDARDS DEVELOPMENT ACTIVITIES

This article was originally published in The Gray Sheet

Executive Summary

DEVICE CENTER REVIEW OF STANDARDS DEVELOPMENT ACTIVITIES is slated to begin in early July, according to staffers at FDA's Center for Devices and Radiological Health. The program review is being undertaken to "be sure our level of participation is consistent" with device center priorities, CDRH Director Bruce Burlington said in a recent memo. The review will be headed by CDRH's office of standards and regulations and will involve staffers from the other major CDRH offices such as device evaluation and compliance. Recommendations on which standards activities to continue and which to eliminate will be made to device center managers later in the year, according to FDAers. Factors that the review committee will take into consideration in evaluating CDRH standards activities include the existence of other, similar standards for a device type and the potential risks posed by a device. The center also is likely to place higher priority on international standards activities, FDAers say. In addition to its own standards-writing activities, CDRH participates in a number of standards groups, such as the International Standards Organization, the International Electrotechnical Commission, the American National Standards Institute and the National Committee of Clinical Laboratory Science. The standards program review is one of at least two CDRH initiatives aimed at more closely linking device center activities with regulatory responsibilities. A similar review of the device center's research program is slated to begin on June 30, when a program review steering committee will hold its first meeting. The steering committee, formed the week of June 21, is being co- chaired by Lillian Gill, interim director of CDRH's office of science and technology, and Thomas Callahan, an associate director of the division of general and restorative devices at the office of device evaluation. The committee also includes Jerry Collins, director of the office of research resources at the Center for Drug Evaluation and Research, and Kenneth Seamon, associate director for research at FDA's biologics center. The first task of the committee will be to develop criteria for assessing CDRH's research activities and design the actual review process. The program review is expected to be completed and recommendations for changes made by October. Although the OST program review seeks to more closely align CDRH research with pre- and post-market activities, the project is not likely to result in the permanent transfer of OST staffers to ODE, FDAers say. The permanent transfer of research staff to the device evaluation program was recommended in the recent House Energy and Commerce oversight subcommittee report on CDRH ("The Gray Sheet" June 7, p. 6). Although OST staffers will continue to assist in review of device submissions on a temporary basis, their permanent transfer to ODE would not be practical because OST resources are stretched too thin, according to device center staffers. OST is losing roughly 40 people with the transfer of the division of biometrics sciences to the new office of surveillance and biometrics (see related item, In Brief).

You may also be interested in...



Mustang Bio Enters Race For CAR-T In Autoimmune Disease

The biotech company’s CEO talked to Scrip about plans to bring the CD20-targeting CAR-T MB-106 into an investigator-sponsored Phase I trial later this year.

Aldeyra Hopes To Refile Dry Eye Drug Reproxalap Later In 2024

Following an FDA complete response letter last November, Aldeyra has agreed with the agency on a trial design to demonstrate efficacy in ocular discomfort, which the company can complete this year.

Colorado Price Cap Plan For Enbrel Draws Amgen Lawsuit; Cosentyx, Stelara ‘Affordability’ Reviews Pending

However, the state's recently formed prescription drug affordability board found Gilead’s Genvoya and Vertex’s Trikafta to be affordable.

Latest Headlines
See All
UsernamePublicRestriction

Register

MT000811

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

Cancel