Medtech Insight is part of the Business Intelligence Division 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

UsernamePublicRestriction
UsernamePublicRestriction

Bone density meters get easier path to market

This article was originally published in The Gray Sheet

Executive Summary

Bone sonometer devices, which transmit ultrasound energy into bone to determine fracture risk, are down-classified to 510(k) status, FDA says in a July 17 final rule. FDA initiated the reclassification process in February 2006 based on evolving evidence. The final special controls 1guidance, superseding the 2006 draft and a 2001 guidance on PMA submissions for bone sonometers, describes measures to mitigate risks such as electrical hazards, electromagnetic interference and tissue damage
Advertisement
Advertisement
UsernamePublicRestriction

Register

MT026345

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

Cancel