Showing all posts written by Paige Cappelli
FDA Draft Guidance for Fostering Medical Device Improvement Using the Voluntary Improvement Program
On May 5, 2022, the FDA’s Center for Devices and Radiological Health (CDRH) issued draft guidance regarding the FDA’s Voluntary Improvement Program (“VIP”). The draft guidance, Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program, can be found here. According to the FDA:
“The VIP is a voluntary program facilitated through the Medical Device Innovation Consortium (MDIC) that evaluates the capability and performance of a medical device manufacturer’s practices using third-party appraisals, and is intended to guide improvement to enhance the quality of devices.”
The VIP draft guidance, is an extension of the 2018 pilot program Case for Quality Voluntary Medical Device Manufacturing and Product Quality (“CfQ Pilot Program”). According to the FDA, the CfQ Pilot Program assessed the “capability and performance of key business processes using a series of integrated best practices detailed in the Information Systems Audit and Control Association (ISACA) Capability Maturity Model Integration (CMMI) system.” The results of the pilot program can be found here. Participants in the CfQ Pilot Program reported that “the appraisal had a direct value to product quality and over 90% reported a positive experience with the appraisal.”
As described in the draft guidance, the goal of the VIP is to “elevate and enhance manufacturing practices and behaviors through which quality and safety of medical devices can be improved.” As indicated in its name, this program is voluntary. Through use of the program, third-party appraisers visit participants to evaluate their practices in order to identify strengths and areas for improvement.
According to the draft guidance, VIP offers various benefits and opportunities for those manufacturing sites who demonstrate sustained capability and performance. Examples of opportunities from the draft guidance include:
- FDA Consideration in Risk-Based Inspection Planning
- Utilization of a Modified Submission Format for Premarket Approval Application (PMA) and Humanitarian Device Exemption (HDE) 30-Day Change Notices for Modifications to Manufacturing Procedures or Methods of Manufacture
- Utilization of a Modified Submission Format for PMA and HDE Manufacturing Site Change Supplements
- Utilization of a Modified Submission Format for PMA or HDE – Manufacturing Modules
The VIP has various participation and enrollment criteria for manufacturing sites, which can be found here.
The FDA requests comments on the draft guidance by July 5, 2022.
FDA Issues Draft Guidance for Software Contained in Medical Devices
On November 3, 2021 the FDA issued draft guidance titled “Content of Premarket Submissions for Device Software Functions.” The final version will eventually replace the FDA’s “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices,” originally released in May 2005.
In a press release Bakul Patel, director of the FDA’s Digital Health center, stated:
“As technology continues to advance all facets of health care, software has become an important part of many products and is integrated widely into medical devices. The FDA recognizes this evolving landscape and seeks to provide our latest thinking on regulatory considerations for device software functions that is aligned with current standards and best practices.”
The draft guidance pertains to software in a medical device (“SiMD”) and software as a medical device (“SaMD”). The Regulatory Affairs Professional Society (RAPS) describes SiMD as “software that is a part of a medical device or controls it” and SaMD as “software that meets the definition of a device but is not part of the overall device’s hardware.” According to the FDA, both SiMD and SaMD are “device software functions.”
The draft guidance is intended to cover: firmware and other means for software-based control of medical devices, stand-alone software applications, software intended to be operated on general-purpose computing platforms, dedicated hardware/software medical devices, and accessories to medical devices when those accessories contain or are composed of the software.
Portions of the draft guidance to consider include the software device documentation and software risk management requirements. Software may require a basic or enhanced level of documentation, depending on risk to a patient, user, other individual, or environment. A risk assessment and risk management plan may be required.
The draft guidance can be found here.
FDA Taking Steps to Prevent Future Medical Device Shortages
According to the FDA, the medical device industry experienced significant supply chain disruptions during the COVID-19 pandemic. Such disruptions caused shortages of PPE, ventilators, diagnostic testing, and other medical devices. As Janet Woodcock, M.D., the Acting Commissioner of Food and Drugs, acknowledges in her July 21, 2021 statement:
“the pandemic has exposed great weaknesses in the medical device supply chain and its dependence on foreign medical devices.”
Woodcock also explains the steps being taken by the FDA to avoid such shortages in the future. One step includes a request for $21.6 million to fund a new Resilient Supply Chain and Shortages Prevention Program (RSCSPP). This funding request is part of the FDA’s request for $97 million to support its core safety programs. Woodcock explains “the funding will provide, for the first time, resources to establish a permanent program for U.S. supply chain resilience for medical devices.” RSCSPP’s goal is to prevent and mitigate the supply chain issues like those experienced during the pandemic while reducing dependence on foreign medical devices.
Additionally, the FDA is looking to expand its authority to prevent future shortages. The FDA seeks broader authority “to obtain supply disruption notifications for critical devices.” Broader authority has also been requested to require manufacturers to develop and share risk management plans. The FDA plans to work with Congress to ensure the FDA has the resources and authority needed to advance these initiatives.
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