US FDA PLANS TO USE ISO 13485 FOR MEDICAL DEVICES REGULATION

ISO - Original publisher

By Barnaby Lewis

The US Food and Drug Administration (FDA), the government department that regulates the medical devices sector, announced its intention to use ISO 13485 as the basis for its quality system legislation.

ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes, is the International Standard for quality management systems for the medical devices sector. Published in 2016, it is designed to work with other management systems in a way that is efficient and transparent. The standard, which is now in its third edition, received strong support from the FDA, in line with its drive for global convergence of medical device regulatory processes.

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TRUMP TO PHARMA CEOS: 75% TO 80% OF FDA REGULATIONS WILL BE ELIMINATED

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Website

Posted 32 January 2017

By Zachary Brennan

"In a sign of what’s to come for the US Food and Drug Administration (FDA), President Donald Trump told pharmaceutical company CEOs Tuesday that his administration will be “cutting regulations at a level no one has ever seen before.”

The comments, which came before the meeting with CEOs from industry group PhRMA, Merck, Novartis, Johnson & Johnson, Celgene and others, Trump said in terms of the drug approval process: “We’re also going to be streamlining the process, so that from your standpoint, when you have a drug you can actually get it approved, instead of waiting for many, many years."

He also called for significantly lower drug prices and again for better negotiations on drug prices between Medicare and companies.

“We’re going to get the approval process much faster,” he repeated, noting that “one thing that’s always disturbed me is that you come up with a new drug for a patient that’s terminal and FDA says you can’t have this drug used on this patient and patient will be dead… we don’t know if drug works or doesn’t work, but the patient’s not going to live for more than 4 weeks.” "

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