Pre-market Submissions for Device Software Functions

 

Software as A Medical Device (SaMD) has been shaping the MedTech industry for quite a while. Many of our clients and other developers wanting to launch and sell their products in the USA were worried about the changing US FDA guidelines. As you all know, Sales of medical devices in the European or USA medical device market are restricted by many regulatory requirements. Therefore, any manufacturer outside the country’s territory needs the support of a chain of economic operators.

 

These economic operators assist the medical device manufacturer with relevant regulatory representation. Before launching in the USA, companies must obtain a 510(k) and/or Pre-Market Approval. This submission involves a tedious process of finding substantial equivalence and other requirements.

 

For quite a long time, the MedTech industry has been awaiting information on the contents of pre-market submissions for device software functions from the US FDA (Food and Drug Administration).

 

Finally, on 14^th June 2023, the FDA published the final guidance: Content of Pre-market Submissions for Device Software Functions.

 

This guidance document is intended to provide information regarding the recommended documentation for pre-market submissions for FDA’s evaluation of the safety and effectiveness of device software functions, which are software functions that meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Developers should know that during pre-market review, FDA may request additional information that is needed to evaluate the submission.

As per he guidance, it is recommended that a reasonable assurance of safety and effectiveness for devices that use software should be accompanied with documentation related to the requirements of the Quality System Regulation (QSR) (21 CFR Part 820).

 

Some Quick pointers for software developers and manufacturers –

• Recommended Documentation:

Through this guidance, the FDA highlights some recommendations for information to be included in pre-market submissions for Basic and Enhanced Documentation Levels. Here is the Outline of Recommended Documentation:

• Documentation Level Evaluation (Section VI.A)  A statement indicating the Documentation Level and a description of the rationale for that level.
• Software Description (Section VI.B) Software description, including overview of significant software features, functions, analyses, inputs, outputs, and hardware platforms.
• Risk Management File (Section VI.C) Risk management plan, risk assessment demonstrating that risks have been appropriately mitigated, and risk management report.
• Software Requirements Specification (SRS) (Section VI.D) SRS documentation, describing the needs or expectations for a system or software, presented in an organized format, at the software system level or subsystem level, as appropriate, and with sufficient information to understand the traceability of the information with respect to the other software documentation elements (e.g., risk management file, software design specification, system and software architecture design chart, software testing).
• System and Software Architecture Design (Section VI.E) Detailed diagrams of the modules, layers, and interfaces that comprise the device, their relationships, the data inputs/outputs and flow of data, and how users or external products (including information technology (IT) infrastructure and peripherals) interact with the system and software.

For the next set of documentation, contacting Regulatory Affairs specialists/consultants is highly recommended, who can guide you with the appropriate strategy.

• Software Design Specification (SDS) (Section VI.F)
• Software Development, Configuration Management, and Maintenance Practices (Section VI.G)
• Software Testing as Part of Verification and Validation (Section VI.H)
• Software Version History (Section VI.I)
• Unresolved Software Anomalies (Section VI.J)

 

Original guidance can be found on this link - https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-premarket-submissions-device-software-functions

 

Irrespective of the guidance and development, Medical Software Developers and Manufacturers must ensure:

• Establishing a strategic pathway to achieve and maintain relevant certifications.
• Implementing a Quality Management system to ensure compliance with Quality System Regulation [QSR].
• Regular Cybersecurity audits, Component communications audits.
• Performing regular gap analysis to identify potential threats and vulnerabilities.

Experts at Med-Di-Dia support all companies in navigating all the Regulatory Requirements and acing cybersecurity per regulatory standards.

Contact our experts for complete support by sending an email to

mdd@mddltd.com or visiting this link -

 

https://mailchi.mp/cef1e53ebb00/digitalhealth

 

 

We are here to be your Regulatory Risk Partner for Medical Devices, Diagnostics and Digital Health!

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