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Meet FDA Requirements

Meet FDA Requirements

Meet FDA Requirements for Medical Device Company Compliance Most medical device executives know they need FDA clearance to legally market and promote their product in the U.S. Beyond FDA approval, understanding how to effectively commercialize a medical device product means adapting to industry and legal expectations for operating as a medical device company. These expectations ensure that you deliver safe and effective products. Knowledge and experience is required to do this effectively and to avoid costly mistakes. At this point, it’s important to realize that although we talk about the FDA as a regulatory body, it is, in fact, a law enforcement agency with the powers associated with such authorities. The FDA can cite, fine and prosecute for violations of laws, such as 21 CFR Part 820 or 21 CFR Part 11. The laws the FDA enforces are administrative laws that are part of a national regulatory scheme, like police law and international trade. Medical device companies not compliant with 21 CFR Part 820, and other applicable regulations, make themselves vulnerable to FDA enforcement practices. The tricky part is that the FDA doesn’t tell you how to operate as a compliant company. You have the flexibility to implement the necessary processes to satisfy the applicable regulations and support them with your own compliance practices. However, you’re expected to fully understand the intent of the regulations and meet those expectations—regardless of your size and resources. While FDA enforcement actions rarely result in jail time for executives, they can force expensive corrections and cause significant damage to your reputation. Truly, it’s best to comply to FDA requirements willingly and...
Medical Device Data Systems and Data Integrity

Medical Device Data Systems and Data Integrity

Time to Take a Closer Look at FDA MDDS Moves The FDA recently released a new draft guidance document for Medical Device Data Systems (MDDS). The FDA defines MDDS as “hardware or software products that transfer, store, convert formats and display medical device data. An MDDS does not modify the data, and it does not control the functions or parameters of any connected medical device. MDDS are not intended to be used in connection with active patient monitoring.” The core issue it raises, I believe, is one of data integrity. More on that later. Explaining the Medical Device Data Systems Draft Guidance The new draft guidance cites the growing trend “that many medical devices be interoperable with other types of medical devices and with various types of health information technology.” And further “since down-classifying MDDS, the FDA has gained additional experience with these types of technologies, and has determined that these devices pose a low risk to the public,” the FDA wrote. “Therefore, the FDA does not intend to enforce compliance with the regulatory controls that apply to MDDS devices, medical image storage devices and medical image communications devices.” The FDA’s interest in this kind of risk based approach has pleased a great many. On the one hand, the draft guidance demonstrates a proactive approach by the FDA for addressing the explosion of mobile health applications in the light of pending legislation on the same topic in the US Congress. It frees application developers to innovate without the additional burden of regulatory compliance, and it dovetails with the rapidly expanding electronic health ecosystem servicing the informational appetites of healthcare...
Cloud Vendor Selection for Life Sciences

Cloud Vendor Selection for Life Sciences

Benefits and Risks of Moving to the Cloud, Including Cloud Vendor Selection Migrating to the Cloud: What are the Benefits? According to the National Institute of Standards and Technology, the cloud is “a model for enabling convenient, on-demand network access to a shared pool of configurable computing resources (e.g., networks, servers, storage, applications, and services) that can be rapidly provisioned and released with minimal management effort or service provider interaction.” Most companies’ IT infrastructure use less than 30% of their capacity. It took years to get the capacity to where it is today, and it takes months to increase capacity. Employing qualified resources to maintain such an infrastructure is difficult and expensive. Cloud providers utilize about 65% of their capacity and can add capacity quickly. In short, cloud providers benefit from economies of scale, which enables them to lower individual usage costs and centralize infrastructure costs. Companies benefit by only paying for what they consume. Companies can increase or decrease their usage rapidly, and can spend less time managing complex IT resources. Not only do efficiency improvements reduce costs, the nature of some costs can change from being capital investment in hardware and infrastructure (CapEx) to a pay-as-you go (OpEx) model. Maximizing IT capacity utilization, improving IT flexibility and responsiveness, and minimizing cost are not the only advantages of the cloud. Collaboration can be one of the most important advantages of cloud computing. Multiple users, from around the world, can collaborate more easily on documents and projects. Because the information is hosted in the cloud, and not on individual computers, business owners can collaborate with external stakeholders in a...