How These New Medical Device Standards Could Affect You
As professionals in the medical device industry, it’s essential to stay up to date with the latest tools, trends, and technologies to keep our clients ahead of the curve. The latest changes we want to bring to the attention of medical device stakeholders’ are the new standards released by the U.S. Food and Drug Administration department.
It includes Computer Software Assurance for Production and Quality Systems. It also provides Software Draft Guidance for Industry and Food and Drug Administration Staff. Read on to learn more.
43 - FDA envisions a future state where the medical device ecosystem is inherently focused on device
44 - features and manufacturing practices that promote product quality and patient safety. FDA has
45 - sought to identify and promote successful manufacturing practices and help device
46 - manufacturers raise their manufacturing quality level. In doing so, one goal is to help
47 - manufacturers produce high-quality medical devices that align with the laws and regulations
48 - implemented by FDA. Compliance with the Quality System regulation, Part 820, is required for
49 - manufacturers of finished medical devices to the extent they engage in operations to which Part
50 - 820 applies. The Quality System regulation includes requirements for medical device
51 - manufacturers to develop, conduct, control, and monitor production processes to ensure that a
52 - device conforms to its specifications (21 CFR 820.70, Production and Process Controls),
53 - including requirements for manufacturers to validate computer software used as part of
54 - production or the quality system for its intended use (see 21 CFR 820.70(i)).4 Recommending
55 - best practices should promote product quality and patient safety and correlate to higher-quality
56 - outcomes. This draft guidance addresses practices relating to computers and automated data
57 - processing systems used as part of production or the quality system.
59 - In recent years, advances in manufacturing technologies, including the adoption of automation,
60 - robotics, simulation, and other digital capabilities have allowed manufacturers to reduce sources
61 - of error, optimize resources and minimize patient risk. FDA recognizes the potential for these
62 - technologies to provide significant benefits for enhancing the quality, availability, and safety of
63 - medical devices, and has undertaken several efforts to help foster the adoption and use of such
64 - echnologies.
66 - Specifically, FDA has engaged with stakeholders via the Medical Device Innovation Consortium
67 - (MDIC), site visits to medical device manufacturers, and benchmarking efforts with other
68 - industries (e.g., automotive, consumer electronics) to keep abreast of the latest technologies and
69 - to better understand stakeholders’ challenges and opportunities for further advancement. As part
70 - of these ongoing efforts, medical device manufacturers, have expressed a desire for greater clarity
71 - regarding the Agency’s expectations for software validation for computers and automated data
72 - processing systems used as part of production or the quality system. Given the rapidly changing
72 iii - Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm
72 iv This guidance discusses the “intended use” of computer software used as part of production or the quality system (see 21 CFR 820.70(i)), which is different from the intended use of the device itself (see 21 CFR 801.4).
72 v- Contains Nonbinding Recommendations Draft – Not for Implementation
73 - nature of software, manufacturers, have also expressed a desire for a more iterative, agile
74 - approach for validation of computer software used as part of production or the quality system.
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