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


Home uterine activity monitors

This article was originally published in The Gray Sheet

Executive Summary

HUAMs for detection of preterm labor should be downclassified from Class III to Class II, FDA tentatively concludes in a July 30 Federal Register notice. The agency says it agrees with the recommendations put forth during an October 1997 meeting of its Obstetrics and Gynecology Devices Panel, which was convened to respond to a petition seeking downclassification of the devices submitted to FDA by Corometrics Medical Systems (1"The Gray Sheet" Oct. 13, 1997, p. 11). Following its review of public comments, the agency plans to approve or deny the petition via a letter to Corometrics. In a separate July 30 Federal Register notice, FDA issues a revised draft guidance document with advice on premarket submissions for HUAMs. The document is identical to an earlier draft of the guidance (2"The Gray Sheet" May 31, In Brief), except for a recommendation on the type of information that should be stored in HUAM patient registries

You may also be interested in...

Home uterine activity monitors

Draft guidance document recently issued by FDA recommends that premarket submissions for the devices include results "from a small clinical study (n=25) that is designed to show that the device produces tracings at the receiving station that are readable, i.e., that contractions are correctly perceived by the clinician." The document is intended to be used as a special control for the devices following their downclassification from Class III to Class II. In 1997, FDA's Obstetrics and Gynecology Devices Panel recommended the regulatory change, provided that special controls, including patient registries, are used ("The Gray Sheet" Oct. 13, 1997, p. 11)


Using home uterine activity monitor patient registries as a Class II special control would help provide reasonable assurance of safety and effectiveness to justify downclassification of the devices for use in preterm monitoring, FDA's Obstetrics and Gynecology Devices Panel concluded at an Oct. 7 meeting in Rockville, Maryland. The panel unanimously voted (7-0) to recommend downclassification from Class III.

EWG Study Suggests More Than One In 10 Talc-Based Cosmetics Contain Asbestos

The Environmental Working Group and Scientific Analytical Institute say inadequate testing of talc-containing personal-care products is to blame for findings of asbestos in cosmetics, including three of 21 powder-based cosmetics SAI analyzed at EWG’s request. They continue to push for updated testing standards that include electron microscopy as a core component.




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