While participation in the program is a great opportunity to shape policy and form relationships with key stakeholders at FDA, potential participants should consider whether their quality systems and product development processes are sufficiently developed to facilitate meaningful engagement with FDA. Participation may require a commitment of time and resources from the company, but the payoff may be greater insight into FDA’s thinking and approach to the development and regulation of current and future digital health products. Finally, it’s important to remember that although the PreCert pilot offers the potential for an expedited path to market through pre-certification or “streamlined premarket review” (e.g., submission of reduced content and/or expedited review by FDA), clearance or approval of the product are not guaranteed. … [Read more...] about US Food and Drug Administration’s New Digital Health Innovation Action Plan Details Software Precertification Pilot Program
Fda software validation requirements
In practice, what would an LDT developer need to do to avail itself of the “unmet needs” pathway? Under the discussion paper, laboratories would have up to 90 days after first offering an LDT for an unmet need to send a premarket submission to the FDA or an accredited third-party reviewer, and could continue to offer the test during the review of such submission. It is unclear, however, whether the agency intends to allow retain this flexibility in all circumstances. For example, what if the developer submits a 510(k), but the agency believes that a PMA is required? Or what if the developer’s submission relies almost entirely on retrospective registry data, while the agency believes that prospective data are required? … [Read more...] about FDA Outlines Substantially Revised ‘Possible Approach’ to Regulation of Laboratory-Developed Tests
Novel Clinical Trial Designs. FDA will be required to hold public meeting and issue guidance documents that would assist sponsors in incorporating adaptive designs and novel statistical modeling into new drug applications. “Adaptive designs” refer to changes in the design or analyses of a trial based on an examination of the accumulated data at an interim point in the trial. For example, adaptive designs can be used to make studies more efficient (e.g. by reducing the duration of the study) or more informative (e.g., by providing broader dose-response information.) The FDA provided guidance on adaptive designs in 2012. … [Read more...] about Senate Passes 21st Century Cures Act, but Can It Cure an Ailing FDA?
The draft guidance states that throughout the medical device lifecycle a medical device firm should establish, document, and maintain an ongoing process for identifying hazards associated with the cybersecurity of a medical device, estimating and evaluating the associated risks, controlling these risks, and monitoring the effectiveness of the controls, as part of their risk management process consistent with 21 CFR part 820. The process should include risk analysis, risk evaluation, risk control, and incorporation of production and post-production information. The draft guidance includes an appendix identifying the elements which should be included as part of the manufacturer’s cybersecurity risk management program. According to the guidance, firms should have a defined process to conduct systematically a risk evaluation and determine whether a cybersecurity vulnerability affecting a medical device presents an acceptable or unacceptable risk. FDA recommends that firms define and … [Read more...] about FDA Issues Draft Guidance on Cybersecurity for Medical Devices
In all cases, FDA recommends that manufacturers make a binary determination that a vulnerability is either controlled or uncontrolled using an established process that is tailored to the product, its essential clinical performance, and the situation. A vulnerability is considered controlled when there is a sufficiently low residual risk that the device’s essential clinical performance could be compromised by successful exploitation of the vulnerability. In contrast, a vulnerability is uncontrolled when there is unacceptable residual risk that the device’s essential clinical performance could be compromised due to insufficient risk mitigation and compensating controls with respect to such vulnerability. … [Read more...] about FDA Releases Draft Guidance on Postmarket Management of Cybersecurity in Medical Devices