FDA will publish shortly a guidance document on how the agency will use ISO 13485 audit reports voluntarily submitted by device manufacturers. The idea is that these manufacturers can be classified as a “low priority inspection” need because they will have shown the FDA that they have already been audited. This way FDA can focus on manufacturers which do not have a ISO audited system.

Original nrews from the website site FDANews.com - FDA Plans to Release ISO Audit Guidance Shortly.

I was warned at the Elsmar Cove Forum - thanks Dustyn!

A quickie, i haven´t read it yet and won´t in the near future:

NIST (National Institute of Standards and Technology) published a report labelled “The Impact of Calibration Error in Medical Decision Making” where, using as example clinical tests for measurement of calcium levels in blood, an analysis is made of the impact of device calibration in the desicion making, and in general the costs, related to the health care system. One-phrase summary:

..calibration errors in measurements of calcium levels in blood may add between $60 million and $199 million to U.S. health care costs annually..

Read the report release news here.

A checklist for the safe and effective use and mantainance of a home healthcare medical device has been published by CDRH from the FDA.

Titled “Home healthcare medical devices - a checklist“, it has some precious tips for users.

Ajit from the Elsmar Cove gave the tip.