2019 IMDRF Guidance Changes Related to Clinical Evidence, Evaluation, and Investigations
Since the release of the European Medical Device Regulation and MEDDEV 2.7/1 Rev 4, medical device regulatory professionals are craving clarity on issues related to clinical data that supports new global submissions and ongoing regulatory compliance. Late in 2019, the International Medical Device Regulators Forum (IMDRF) issued three updated guidance documents that clear up confusion […]
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The US FDA is Shifting Toward ISO 13485. But How Much and How Soon?
Earlier this month, the US FDA officially announced their intention to shift toward international harmonization of the US Quality System Regulation (QSR). The medical device industry is likely to give a collective thumbs-up to the proposal, although its impact is unlikely to be felt anytime soon. Known more formally as 21 CFR Part 820, the […]
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How Quality System Harmonization Supports Growth
Do any of These Quality System Challenges Sound Familiar? “Me too” nonconformances or 483 observations occurring in different areas of the business. “We do it this way” responses that differ by area when you ask employees how they execute quality system requirements. “I didn’t know that” responses when asked about an organizational quality goal. “How […]
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CAPA and P&PC: How to Handle These Two Medical Device Compliance Troublemakers
What can FDAΓÇÖs data tell you’ Sometimes you learn something new ΓÇÆ other times the data validates what you already know. FDAΓÇÖs CY 2016 Annual FDA Medical Device Quality System Data reveals that Corrective and Preventive Action (CAPA) and Production and Process Controls (P&PC) continue to cause compliance headaches for medical device manufacturers. The data […]
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FDA Proposes Expanding the List of 510(k) Exempt Devices: What You Need to Know
What: On March 14, 2017, FDA published a formal notice proposing to make hundreds of Class II medical devices exempt from premarket notification requirements that necessitate a 510(k) submission.* Note that there are a few exceptions for specific indications of medical devices. All devices will still need to meet other FDA requirements, such as 21 […]
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