FDA / EU / Regulatory Updates
There are several medical device guidance documents related to software, cybersecurity and usability (human factors engineering).
A-List: Prioritized Guidance Documents that CDRH Intends to Publish in FY2022
Final Guidance Topics
- Clinical Decision Support Software
- Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act
- Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order
- Remanufacturing of Medical Devices
- Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices
- Electronic Submission Template for Premarket Notification (510(k)) Submissions
Draft Guidance Topics
- Computer Software Assurance for Production and Quality System Software
- Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program
- Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
- Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
- Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
- Content of Premarket Submissions for Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD)
- Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers
- Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care
- Medical Device Shortages – Implementation of Section 506J of the Federal Food, Drug, and Cosmetic Act
- Clinical Considerations for Medical Device Premarket Submissions Targeting Opioid Use Disorder
B-List: Guidance Documents that CDRH Intends to Publish, as Guidance Development Resources Permit in FY2022
Final Guidance Topics
- Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices
- Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations
Draft Guidance Topics
- Questions & Answers Regarding Certificates for Devices Not Exported from the United States (CDNE)
- Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations – Premarket Notification (510(k)) Submissions
- Content of Human Factors Information in Medical Device Marketing Submissions
- Marketing Submission Recommendations for A Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions
Risk Categorization for Software as a Medical Device: FDA Interpretation, Policy, and Considerations
The De Novo request provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device. De Novo classification is a risk-based classification process.
Devices that are classified into class I or class II through a De Novo classification request (De Novo request) may be marketed and used as predicates for future premarket notification [510(k)] submissions, when applicable.
There are two options to submit a De Novo request for the FDA to make a risk-based evaluation for classification of the device into class I or II.
- Option 1: After receiving a high-level not substantially equivalent (NSE) determination (that is, no predicate, new intended use, or different technological characteristics that raise different questions of safety and effectiveness) in response to a 510(k) submission.
- Option 2: Upon the requester’s determination that there is no legally marketed device upon which to base a determination of substantial equivalence (therefore without first submitting a 510(k) and receiving a high-level NSE determination).
If the De Novo request is declined, the device remains in class III and the requester may not legally market the device until PMA application is approved.
The FDA will decline a De Novo request if:
- General controls or general and special controls are insufficient to provide reasonable assurance of safety and effectiveness of the device; or
- The data provided in the De Novo request are insufficient to determine whether general controls or general and special controls can provide a reasonable assurance of safety and effectiveness of the device; or
The probable benefits of the device do not outweigh the probable risks.
The ROSA One 3.1 Brain Application is a robotic platform that helps neurosurgeons with positioning medical instruments or implants during surgery. The device is composed of a compact robotic arm and a touch screen mounted on a stand. Different types of instruments or tools (for example, biopsy needles, stimulation or recording electrodes, endoscopes) may be attached to the end of the robotic arm, depending on the surgical procedure.
Zimmer Biomet is recalling this product due to a software error that could lead to incorrect placement of instruments during stereotactic neurosurgical procedures (for example, techniques to direct the tip of a tool using coordinates provided by medical imaging to reach a specific part of the brain). If this occurs, it could cause adverse events such as stroke, serious injury, severe disability, and death.
There have been three complaints about this device issue. There have been no deaths or injuries reported about this device issue.
Zimmer Biomet is headquartered in Warsaw, Indiana.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.