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

UsernamePublicRestriction
UsernamePublicRestriction

FIRMS MUST INCLUDE EMC TEST RESULTS AND CRITERIA WHEN DECLARING CONFORMANCE TO IEC 60601-1-2 STANDARD; FDA TO PUBLISH 60601 ADOPTION PROPOSAL IN COMING WEEKS

This article was originally published in The Gray Sheet

Executive Summary

Manufacturers declaring conformity to the International Electrotechnical Commission's 60601-1-2 electromagnetic compatibility standard must include data from the EMC testing performed, FDA says in an Oct. 10 draft Blue Book memo to Office of Device Evaluation review staff. The memo is intended to provide ODE reviewers guidance on the use of the IEC 60601 series of device safety standards during the evaluation of premarket submissions.

You may also be interested in...



Cosmetic And Personal Care Trademark Review 24 November, 2020

Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.

CBD Health Benefits More Attractive To Women? FDA Prioritizes Research Into Utero Effects

Among the largest gaps in safety data is non-clinical research on CBD use's effect on developing fetus and adolescent brain, in utero/lactational exposure, reproductive toxicity and the potential for a latency period before toxicity, says FDA  neuroscientist Andrew Shen.

COVID-19 Serology Templates: FDA Updates Sponsor Template, Adds Home Test Document

The templates from the US agency provide guidance to manufacturers developing antibody tests for clinical or at-home use.

UsernamePublicRestriction

Register

LL1134531

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