The article highlights the key points associated with the concept of evidentiary expectations in the context of marketing submissions.
Table of content
The Food and Drug Administration (FDA or the Agency), the US regulating authority in healthcare products, has published a draft guidance document dedicated to evidentiary expectations for 510(k) implant devices.
Once finalised, the document will provide an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved to ensure compliance with it.
At the same time, it is essential to mention that provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations.
Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the existing legislation. It has been agreed with the authority in advance.
The present draft guidance document, issued by the FDA, outlines the Agency’s current thinking regarding submitting and evaluating premarket notifications (510(k)) for implant devices.
The guidance is intended to enhance the predictability, consistency, and transparency of the 510(k) program, particularly for implant devices. It serves as a primary resource alongside device-specific guidances addressing particular matters.
Regulatory Background
First, the document briefly describes the FDA’s efforts to modernise the 510(k) Program, a vital component of the FDA Medical Device Safety Action Plan.
This modernization aims to improve medical device safety while ensuring efficient pathways for device approval.
The document highlights the authority’s commitment to evolving and improving the 510(k) Program in response to technological advancements and public feedback, ensuring a balance between innovation and patient safety.
The guidance applies specifically to implants requiring a 510(k) submission, excluding devices subject to premarket approval or exempt from 510(k) requirements.
It defines an implant as a device intended to remain implanted for 30 days or more but also considers devices intended for shorter implantation periods due to cumulative exposure concerns.
Key Aspects
The document further describes in detail the most important aspects related to the matter, including:
- Evidentiary Expectations: According to the guidance, this concept clarifies the evidence required in 510(k) implant submissions, focusing on performance testing and other content, such as proposed labelling.
This includes addressing risks associated with implants and considerations throughout the product lifecycle. - Consensus Standards: The document references the FDA-recognized consensus standards and advises on their use in regulatory submissions, encouraging alignment with industry standards.
These standards could be used by medical device manufacturers to demonstrate compliance with the relevant regulatory requirements. - Substantial Equivalence (SE) Determination: The guidance explains the process for determining if a new device is substantially equivalent to a predicate device.
It involves comparing intended uses, technological characteristics, and safety and effectiveness. The benefit-risk profile of new devices with different technical characteristics is critical for SE determination.
The concept of substantial equivalence was introduced to reduce the regulatory burden for the parties interested in placing medical devices on the market. - Data Requirements: For implants, a combination of non-clinical and clinical data is often necessary to demonstrate safety and effectiveness.
The document also acknowledges the potential need for additional information during the review process to support SE determinations. - Transparency and Consistency: The guidance aims to enhance the transparency and predictability of the review process for implants, offering a comprehensive resource for understanding performance data requirements for SE establishment.
- Device-Specific Guidance and Standards: In this part, the document refers to various other guidances and standards that might apply to specific implant submissions, suggesting that submitters consult device-specific guidances for more detailed requirements.
- Pre-Submission Interaction: By the guidance, the authority encourages submitters to engage with the FDA through pre-submissions to discuss specific questions and clarifications regarding their device.
Conclusion
In summary, the present FDA guidance clarifies the approach to be followed concerning the evidence provided to support marketing submissions for implant devices.
The document highlights the key points to be considered by the interested parties and clarifies the critical regulatory concepts used.
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