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
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...
Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.
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.
The templates from the US agency provide guidance to manufacturers developing antibody tests for clinical or at-home use.