Labeling requirements for multiple models in FDA 510(k) submissions for software

Question

We are preparing to submit FDA 510(k) clearance for multiple software models (e.g., for different diagnostic modalities) within the same software product. Are there specific labeling requirements for the models in the software application itself, or is this only relevant for the clearance documentation? For example, should the GUI explicitly display the model name (e.g., "ProductX-BW" for a bitewing modality) after clearance? Also, if the software is integrated and branded differently for customers, should these variations be included in the proposed labeling? Any experiences or advice would be appreciated.

Dr. Oliver Eidel · Accepted Answer

Assuming you're referring to an ISO 13485 QMS: ISO 13485 doesn't explicitly require KPIs, but it does require you to "monitor and measure processes" and apply suitable methods to do so. In practice, using KPIs is a common way to meet this requirement.
Some examples include:
• Processing times for QMS topics like complaints, CAPAs, or internal audit reports
• Time from issue awareness to CAPA root cause
• Number of overdue corrective actions or audit findings

It's important to decide what values are acceptable, which you may only learn after gathering some baseline data. Your KPIs are useful for trend reports and management reviews, and if you automate any part of your QMS, dashboards can make tracking easier.

Answer

We have a lot of KPIs for quality in our QMS. Some examples include:
• Timelines for processes like supplier corrective action requests (SCAR), CAPA, or health hazard evaluation determinations (HHED)
• Counts of product holds, audits, number of issue evaluations/CAPAs, audit non-conformities, complaints
• Trend analysis, such as tracking how numbers of audit findings, CAPAs closed, or complaints change over time
• Whether all employees are being trained on time

Answer

Making a device inherently safer by design (like using a lower voltage or a less sharp blade) is a good example. Information alone, like telling users to wear a helmet, is less reliable since users may ignore it. If you make a hazard physically impossible or much less severe, that's a design risk control reducing severity.

Answer

Titles like Head of Product, Tech Lead, or Head of Development are commonly used. There are no fixed rules for job titles in a QMS, as long as your documentation is consistent and clear. In some companies, the Head of Product and CTO are on the same level, but this can vary depending on team size and responsibilities.

Answer

We define roles in our QMS along with their responsibilities and keep an overview of who fulfills which role. One person can have multiple roles (like developer and purchasing), and a role can be performed by several people. This system gives enough of an organizational chart for an auditor and keeps things flexible as your team grows or changes.

Labeling requirements for multiple models in FDA 510(k) submissions for software

8 Answers

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