See a news item in 6/2024 that Biomerieux has a new device for throat infections via "SPECIAL 510(k)." What is that?
NEW YORK – BioMérieux announced Wednesday that it has received special 510(k) clearance and CLIA waiver from the US Food and Drug Administration for the BioFire SpotFire Respiratory/Sore Throat (R/ST) Panel Mini test.
The SpotFire R/ST Panel Mini will be available in the US in the third quarter of 2024 and is intended to be commercialized along with the company's larger R/ST panel, the firm said in a statement.
SpotFire R/ST Panel Mini is a 15-minute syndromic PCR panel to detect and differentiate five viral and bacterial causes of respiratory or sore throat infections. Samples can be taken from a nasopharyngeal swab when a respiratory tract infection is suspected or from a throat swab when pharyngitis is suspected.....
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/special-510k-program
Chat GPT discusses.
The Special 510(k) Program offers an efficient review process for certain well-defined modifications to a manufacturer’s own legally marketed device. Here’s a summary of its key aspects and differences from the Traditional 510(k) process:
Special 510(k) Program:
Scope:
- Applicable only to modifications of a manufacturer's own legally marketed device.
- Used for certain changes where design control procedures can produce reliable results to support a substantial equivalence (SE) determination.
Submission Requirements:
- Must include a coversheet identifying the submission as a Special 510(k).
- A description of the modified device, comparison to the legally marketed device, and indications for use.
- Clean and redlined copies of updated documents.
- A concise summary of design control activities and verification/validation testing.
Evaluation Criteria:
- Changes should be supported by well-established methods, with results that can be reviewed in a summary or risk analysis format.
- No new performance data are generally needed, or if required, the data must be reviewable in a summary format.
Review Process:
- Aims for FDA review within 30 days, compared to 90 days for Traditional 510(k) submissions.
- Focuses on leveraging existing data and minimizing the need for detailed test reports.
Limitations:
- Not suitable for significant changes to intended use or fundamental scientific technology.
- Generally excludes changes needing new clinical data, significant reprocessing validations, or introducing new safety concerns.
Traditional 510(k) Program:
Scope:
- Applicable to both new devices and modifications of existing devices.
- Broader range of changes can be considered, including more complex modifications.
Submission Requirements:
- Detailed information including complete test reports, clinical data if needed, and comprehensive descriptions of the device and its intended use.
Evaluation Criteria:
- Thorough evaluation of all performance data, including new clinical or non-clinical data as required.
Review Process:
- Standard review time of 90 days.
- Requires detailed documentation and often a more extensive review process.
Flexibility:
- More flexible in terms of the types of changes that can be evaluated.
- Suitable for significant modifications or when new safety and efficacy data are needed.
Key Differences:
- Review Time: Special 510(k) aims for a quicker 30-day review versus the Traditional 510(k)’s 90 days.
- Data Requirements: Special 510(k) relies on existing data and well-established methods, whereas Traditional 510(k) often requires new, detailed performance data.
- Scope of Changes: Special 510(k) is limited to specific modifications, primarily within the same intended use and technological framework. Traditional 510(k) can handle more substantial changes.
The Special 510(k) process is designed to streamline the review of minor changes to an already cleared device, leveraging the manufacturer’s existing design controls and previous FDA evaluations to ensure that the device modifications are safe and effective without needing extensive new testing or data submission.
For more detailed information on the Special 510(k) Program, you can refer to the FDA guidance document uploaded titled "2019 FDA SPECIAL 510K PROGRAM guidance.pdf".
Yes, there are ways to update a 510(k) device without specifically using the Special 510(k) pathway. The primary methods are:
Traditional 510(k)
- Traditional 510(k): This is the most common pathway and is used for new devices or significant changes to existing devices. It requires a comprehensive submission, including detailed descriptions, performance data, and sometimes clinical data. This pathway can be used for any modifications to a device, regardless of their scope.
Abbreviated 510(k)
- Abbreviated 510(k): This pathway relies on conformity to FDA-recognized consensus standards, special controls, and/or FDA guidance documents. If a device modification conforms to these standards, the submission can reference the standards and provide summary reports, reducing the amount of data that needs to be submitted. This pathway can be used to demonstrate substantial equivalence through a reliance on established standards.
Special 510(k)
- Special 510(k): As mentioned before, this is for minor modifications to a manufacturer’s own legally marketed device. It leverages design control activities and relies on well-established methods for evaluation, aiming for a quicker review process.
Deciding When to Submit a 510(k) for a Change to an Existing Device
- The FDA provides guidance on deciding when a new 510(k) is necessary for changes to an existing device. Not all modifications require a new 510(k) submission. The key is to determine whether the change could significantly affect the safety or effectiveness of the device.
Key Considerations:
Risk-Based Assessment: Manufacturers should perform a risk-based assessment to decide if a new 510(k) is needed. Minor changes that do not significantly affect the device's performance or safety might not require a new submission.
Documentation: Even if a new 510(k) is not needed, manufacturers must document the changes, rationale, and any testing conducted to ensure continued compliance with FDA regulations.
Changes That Generally Do Not Require a New 510(k):
- Editorial changes to the labeling that do not alter the indications for use.
- Changes in manufacturing processes or facilities that do not affect the device's safety or effectiveness.
- Minor changes in design, such as software updates that do not affect the intended use or performance.
Changes That May Require a New 510(k):
- Changes in indications for use.
- Changes in design that affect the device’s safety or effectiveness.
- Changes in materials that could affect biocompatibility.
- Changes requiring clinical data to demonstrate substantial equivalence.
21 CFR 807.81(a)(3):
- According to 21 CFR 807.81(a)(3), a new 510(k) submission is required for any change or modification that could significantly affect the safety or effectiveness of the device, including changes to the indications for use.
Guidance Documents:
- The FDA has issued guidance documents such as “Deciding When to Submit a 510(k) for a Change to an Existing Device” which provides a flowchart and detailed explanations to help manufacturers determine if a new submission is necessary.
Summary:
- Special 510(k) is just one pathway, specifically designed for minor changes with a streamlined review process.
- Traditional and Abbreviated 510(k) pathways are available for more significant changes or when leveraging recognized standards.
- Not all changes require a new 510(k); manufacturers should perform a risk-based assessment and consult FDA guidance to determine the appropriate action.
These options provide flexibility for manufacturers to update and modify their devices while ensuring continued compliance with FDA regulations and maintaining device safety and effectiveness.
The main differences between the Abbreviated 510(k) and Special 510(k) pathways lie in their requirements, purpose, and the types of modifications they address. Here's a comparison of the two:
Abbreviated 510(k):
Purpose:
- Utilized to streamline the submission process by relying on conformance with FDA-recognized consensus standards, special controls, and FDA guidance documents.
Submission Requirements:
- Requires the submitter to provide summary reports and declarations of conformity to recognized standards.
- May include less detailed information compared to a Traditional 510(k), focusing on demonstrating conformance to applicable standards and controls.
Scope:
- Suitable for new devices or modifications that are covered by existing consensus standards and special controls.
- Often used when well-established standards exist for the device type or specific aspects of its performance.
Evaluation Criteria:
- The FDA evaluates whether the device conforms to recognized standards and special controls.
- Reduced emphasis on providing detailed performance data, as the focus is on conformity to standards.
Review Process:
- Aims to streamline the review process by leveraging standards and guidance documents.
- The review time can vary but is generally intended to be more efficient due to reliance on established standards.
Special 510(k):
Purpose:
- Intended for modifications to a manufacturer's own legally marketed device.
- Designed to streamline the submission and review process for well-defined, minor changes.
Submission Requirements:
- Requires a coversheet identifying it as a Special 510(k).
- A detailed description of the change(s), comparison to the cleared device, updated labeling, and a concise summary of design control activities and verification/validation testing.
- Performance data should be reviewable in a summary or risk analysis format without complete test reports.
Scope:
- Suitable for minor modifications to an existing device that are well-defined and where the design control procedures produce reliable results.
- Not appropriate for significant changes to intended use, fundamental scientific technology, or those requiring new clinical data.
Evaluation Criteria:
- Focuses on whether the modification can be supported by well-established methods and if the results can be reviewed in a summary or risk analysis format.
- Emphasizes leveraging previous FDA reviews and existing design control documentation.
Review Process:
- Aims for a quicker review time, typically within 30 days.
- If the submission is not appropriate for a Special 510(k), the FDA may convert it to a Traditional 510(k), potentially extending the review time.
Key Differences:
Purpose and Focus:
- Abbreviated 510(k) relies on conformance with recognized standards and is suitable for both new devices and modifications.
- Special 510(k) is specifically for minor modifications to an existing device by the same manufacturer.
Submission Content:
- Abbreviated 510(k) requires summary reports and declarations of conformity.
- Special 510(k) requires detailed descriptions of changes, summaries of design control activities, and performance data in summary format.
Scope and Appropriateness:
- Abbreviated 510(k) can be used for a broader range of devices and modifications covered by standards.
- Special 510(k) is limited to specific, well-defined modifications that can be supported by existing design controls and well-established methods.
Review Time:
- Special 510(k) generally aims for a quicker 30-day review.
- Abbreviated 510(k) review time varies but is intended to be efficient through the use of standards.
Both pathways offer streamlined alternatives to the Traditional 510(k) process but serve different purposes and types of device modifications.
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