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
How would FDA decide whether agency oversight of a previously marketed (and therefore, potentially grandfathered) LDT is “necessary to protect the public health”? The agency’s willingness to consider any “grandfathering” of previously marketed LDTs represents a significant shift in the agency’s position. That being said, the agency does not provide any guidance on how it will decide whether agency oversight of a previously marketed LDT is “necessary to protect the public health.” For example, would the agency only take action against LDT developers if it has evidence of actual patient harm (e.g., from adverse event reports)? Or could the agency take the position that oversight of any test with certain high-risk intended use(s) is necessary to protect the public health, regardless of evidence of actual harm? … [Read more...] about FDA Outlines Substantially Revised ‘Possible Approach’ to Regulation of Laboratory-Developed Tests
Accelerated Approval for Regenerative Therapeutic Products. FDA will be allowed to grant accelerated approval for regenerative therapeutic products. FDA is directed to consider the unique characteristics of regenerative therapeutic products and provide a rationale with a determination of whether or not to grant accelerated approval. The Act does not change the standards of evidence or limit any other of the FDA’s authorities. Regenerative therapeutic products include stem cell therapies that are derived from a patient’s own cells. The magazine Wired recently published an in-depth article on the current state of regenerative therapeutic products. … [Read more...] about Senate Passes 21st Century Cures Act, but Can It Cure an Ailing FDA?
Manufacturers should remediate the vulnerabilities to reduce the risk of compromise to essential clinical performance to an acceptable level;When an official fix may not be feasible or immediately practicable, manufacturers should identify and implement risk mitigations and compensating controls, such as a work-around or temporary fix, to adequately mitigate the risk;Manufacturers should report these vulnerabilities to the FDA according to 21 CFR part 806, unless reported under 21 CFR parts 803 or 1004. However, the FDA does not intend to enforce reporting requirements under 21 CFR part 806 if all of the following circumstances are met:There are no known serious adverse events or deaths associated with the vulnerability,Within 30 days of learning of the vulnerability, the manufacturer identifies and implements device changes and/or compensating controls to bring the residual risk to an acceptable level and notifies users, andThe manufacturer is a participating member of an Information … [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