Combination Product Industry News & Guidance

Helpful Links For Software-Connected Combination Product Development

Are you developing software as a medical device (SaMD)? Below are links that can help you identify many of the regulations and considerations you must address to develop (and gain approval on) connected medical devices like wearables, digital health technologies, patient compliance monitors, sensors, patient apps, smart pills, dosing calculators, and medical devices that contain multiple software functions in one:

• Mobile Health App Interactive Tool (FDA, FTC, HIPAA)
• FDA’s Digital Health Technologies (DHTs) for Drug Development website
• FDA Draft Guidance – Regulatory Considerations for Prescription Drug-Use-Related Software
• FDA Guidance – Policy for Device Software Functions and Mobile Medical Applications Guidance (Includes some examples of software that are and are NOT regulated medical devices)
• FDA Guidance – Multiple Function Device Products: Policy and Considerations Guidance
• Cybersecurity in Medical Devices Frequently Asked Questions (FAQs)
• FDA Draft Guidance – Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
• FDA Off-The-Shelf Software Use in Medical Devices Guidance
• FDA Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act Guidance
• FDA General Wellness: Policy for Low Risk Devices Guidance
• FDA – Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices – Guidance
• FDA Guidance Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (Sept 2023) (applies to combination products when device constituent part presents cybersecurity considerations)
• MDCG 2023-4 Medical Device Software (MDSW) – Hardware combinations: Guidance on MDSW intended to work in combination with hardware or hardware components (Oct 2023) (EU)

Reach out if you need any support making sense of these resources or determining how they most appropriately apply to your project.

AUTHOR

Rita Lee, PhD, RAC, Principal Consultant, Suttons Creek, Inc. – Rita has 15+ years of regulatory affairs strategy experience in regulated medical products (combination products, medical devices, and drugs) in startups and larger companies. As global regulatory device lead for devices and combination products over 5 years, she interacted with regulatory agencies, synergized/collaborated with product teams, and championed/proposed solutions-oriented, risk-mitigating regulatory strategy to market and post-market product modifications resulting in marketing approvals/clearances. Rita’s combination products experience has centered on drug delivery. She has guided medical device and combination product regulatory strategy for numerous products, including infusion pumps (pre-filled and user-filled), bioelectronics, mobile apps (software as a medical device, SaMD), in-vitro diagnostics (IVD), and inhalation devices (nebulizers, DPI).