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Across topics and issues, borders and industries, we have the thought leadership you need to stay ahead of changes in the law.
Insights and Analysis
01 March 2022
On February 22, the U.S. Food and Drug Administration (FDA) published its long awaited proposed rule entitled, “Medical Devices; Quality System Regulation Amendments,” which...
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22 June 2021
On June 18, 2021, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Remanufacturing of Medical Devices,” which aims to help clarify the point when...
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07 October 2020
Last week, the U.S. Food and Drug Administration (FDA) updated the information regarding its Voluntary Malfunction Summary Reporting Program (VMSRP) on the FDA Medical Device Reporting...
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19 March 2020
On 18 March 2020, in addition to a series of responses to combat the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) announced that it is temporarily postponing all domestic...
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11 March 2020
On 10 March 2020, FDA announced that it is postponing most foreign inspections through April 2020. This action comes as the latest in a series of agency responses to the coronavirus...
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16 December 2019
ISO 14971:2019 Medical devices – Application of risk management to medical devices is a new update on the 2013 version of this global standard.
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25 November 2019
The U.S. Food and Drug Administration (FDA) indicated that the long-anticipated proposed rule modernizing the Quality System Regulation (QSR) is now targeted for release in April 2020.
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19 November 2019
Drug and medical device manufacturers seeking to export a product from the United States may need to obtain from the U.S. Food and Drug Administration (FDA) a Certificate to Foreign...
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04 April 2019
On 29 March 2019 the U.S. Food and Drug Administration's (FDA) Office of Regulatory Affairs issued a draft guidance document titled "Review and Update of Device Establishment...
