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FDA has formally announced its intention to transition away from the Quality Systems Regulation (QSR) per 21 CFR 820 and transition to the ISO 13485:2016 for its audit inspections of medical device manufacturers. The new rule could be released as soon as mid 2019 and will roll out over the next few years. Industry should begin to perform any...
Medical Device Regulatory Intelligence Blog
Manufacturers may not always take a Total Product Life Cycle (TPLC) approach when preparing their medical device 510(k) Submissions to FDA. This could lead to disconnects down the road if the pre-market, post-market, and quality management systems are not integrated from the get go.
FDA Clarifies the Safety and Performance Based Pathway for devices eligible for Abbreviated 510(k)
04/13/2019
In a draft Guidance Document issued in February 2019, FDA Clarifies the Safety and Performance Based Pathway for devices eligible for Abbreviated 510(k) . The updated guidance is found here: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM604195.pdf
The FDA recently released a guidance document to standardize the way that FDA conducts medical device establishment registrations.
ISO 14971 Standard for Risk Management for Medical Devices is currently being revised and updated with expected release in 2019.
The FDA recently issued a draft guidance titled Nonbinding Feedback After Certain FDA Inspections of Device Establishments, a requirement under the FDA Reauthorization Act of 2017 (FDARA). The draft guidance proposes a process by which companies can request from the FDA nonbinding feedback on certain kinds of documented inspectional observations...
7 Feb18 New Health Canada Guidance Document
02/20/2018
Health Canada recently released a guidance document on: