Medical Device Accessories: Classification and Risk-Based Approach
This guidance describes FDA's policy concerning the classification of accessories to medical devices. It explains what FDA considers an accessory and outlines the processes under Section 513(f)(6) of the FD&C Act to allow requests for risk- and regulatory control-based classification of accessories. The guidance applies to all articles that meet the definition of an accessory device, including software products that may also meet the definition of Software as a Medical Device (SaMD).
What You Need to Know? 👇
What is the FDA’s definition of a medical device accessory?
An accessory is a finished device intended to support, supplement, and/or augment the performance of one or more parent devices. It must be specifically intended for use with parent devices, not just capable of being used with them.
How does FDA classify medical device accessories under the risk-based framework?
FDA classifies accessories based on their risks when used as intended with parent devices and the regulatory controls needed for safety and effectiveness. Accessories may be classified in the same class as their parent device or separately if they have different risk profiles.
What are the two main pathways for requesting accessory classification under Section 513(f)(6)?
The two pathways are: 1) New Accessory Type requests for accessories included in PMA or 510(k) submissions that haven’t been classified distinctly, and 2) Existing Accessory Type requests for accessories already granted marketing authorization with another device.
Can software products be considered medical device accessories?
Yes, software products that meet the definition of “Software as a Medical Device (SaMD)” can be considered accessories if they support, supplement, or augment the performance of parent devices. The same risk-based classification paradigm applies to these software accessories.
What’s the difference between supporting, supplementing, and augmenting a parent device?
Supporting enables the parent device to perform its intended use. Supplementing adds new functions without changing the parent’s intended use. Augmenting enables the parent device to perform more safely, effectively, quickly, or with improved usability.
How long does FDA have to respond to different types of accessory classification requests?
For New Accessory Type requests, FDA must respond concurrently with the parent device submission decision. For Existing Accessory Type requests, FDA has 85 days. For De Novo classification requests, FDA has 120 days to make a determination.
What You Need to Do 👇
Recommended Actions
- Determine if product meets accessory definition by evaluating:
- Intended use with parent device(s)
- How it supports, supplements, or augments parent device performance
- Assess risk profile:
- Evaluate risks when used with parent device
- Identify unique risks independent of parent device
- Determine appropriate regulatory controls
- Choose appropriate classification pathway:
- New Accessory Request for accessories included in PMA/510(k)
- Existing Accessory Request for already marketed accessories
- De Novo process for new accessory types
- Prepare submission documentation:
- Clear identification of request type
- Device information and compatibility data
- Risk assessment and mitigation measures
- Proposed controls
- Performance data
- Labeling with compatibility information
- Consider Pre-Submission meeting with FDA for feedback before formal submission
- Ensure compliance with applicable regulatory controls based on classification
Key Considerations
Software
- Software products that meet the definition of an accessory will be subject to the same risk- and regulatory control-based classification paradigm
- SaMD that uses data from a medical device does not automatically become an accessory
- SaMD may be considered an accessory if it supports, supplements, and/or augments the performance of parent devices
Labelling
- Labeling and promotional materials should determine whether an article is intended for use with a parent device
- Labeling must include adequate instructions for use with parent device(s)
- Include compatibility information and relevant technical characteristics
Safety
- Risk assessment should consider:
- Risks imposed by accessory’s impact on parent device
- Unique risks of accessory independent of parent device
- Risk profile when used as intended with parent device
Other considerations
- Accessory must support, supplement, and/or augment the performance of parent device
- Classification can be different from parent device based on risk profile
- Compatibility with parent device must be demonstrated
- General controls or general and special controls must provide reasonable assurance of safety and effectiveness
Relevant Guidances 🔗
- Content of Premarket Submissions for Device Software Functions
- Clinical Evaluation of Software as a Medical Device (SaMD)
- Quality System Information Requirements for Premarket Submissions
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
- De Novo Classification Process for Novel Medical Devices Without Predicates
Related references and norms 📂
- 21 CFR 820.3: Quality System Regulation - Definitions
- 21 CFR 820.3(c): Component definition
- 21 CFR 820.3(l): Finished Device definition