Special 510k is used for submission, review, and clearance when modifications are made to an existing legally marketed predicate device of the same manufacturer that is already authorized for commercial distribution.
The types of changes that are accepted under Special 510(k) are:
- Some changes to Indications for Use
- Certain types of changes to technological characteristics.
- Labeling or design change to a legally marketed device if
- The manufacturer legally authorized to market the predicate device submits the proposal
- Performance data may or may not be necessary. If necessary, established methods should be in place to evaluate changes made
- Substantial equivalency can be supported using the required performance data reviewed in summary or risk analysis format.
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What are the conditions on which software as a medical device can submit a special 510k?
If the raw material of a 510k approved medical device is changed require a special or new 510k?
If the Traditional 510(k) submitted initially can identify the software verification and validation approaches, subsequent software changes can be included under a Special 510(k). To remain appropriate for review as a Special 510(k), all test methods used to support the 510(k) should be well-established.
The Special 510(k) can be chosen if:
– Changes are made only to strengthen cyber security
– Changes made only to return the system to the specification of the most recently cleared device
– If new risks are not introduced or existing risks are not modified to result in harm
– If clinical functionality or performance specifications associated with intended use are not affected
– If new risk control measures or modification to existing risk control measures that result in harm are not needed
Please refer https://www.fda.gov/media/99785/download for more details on 510(k) for software change to existing device.
Raw material supplier changes that only modify the reference number or brand name of raw materials and do not change the raw material itself can go for a Special 510(k). But, a new 510(k) is needed if the raw material itself is changed.
Please refer https://www.fda.gov/media/99812/download for more details regarding 510(k) for change to existing device.
The Special 510 (K) defines an optional pathway for manufacturers to make certain well defined modifications to their own legally marketed device. For some changes to a device like software design changes, compliance with the quality system regulation which can assure safety and effectiveness of the modified device.
Software modifications may be identified like bug fix, hot fix, patch, software change, code change, or tweak but not limited to….
The Special 510(k) can be considered when
• Change in the cybersecurity which implemented to strengthen the security of a system, protect information and to reduce the disruption in service.
• Modifications done to software mainly to restore the device to the most recently cleared devices specifications that improves safety and effectiveness of the device.
• As a result of software change a new risk is not created or identified, or any existing risk is not modified
• The software change could not affect clinical functionality or performance specifications that are related with the intended use of the device
If the change in raw material like only supplier change which only modifies the reference number or brand name of raw material but no change in the raw material itself. Then special 510k will be considered. In these situations we need to update the existing assessment or a new assessment should be documented.
The decision on to submit special 510((K) when software changes to the existing device is based on several factors. The some of the factors are listed below.
1. If the change made solely to strengthen cybersecurity and does not have any other impact on the software or device.
2. If the change made solely to return the system into the specification of the most recently cleared device.
3. The changes do not create or necessitate a new risk control measure or a modification
of an existing risk control measure.
4. The changes do not significantly affect clinical functionality or performance specifications that are directly associated with the intended use.
5. The type of software.
The decision on the requirement of special 510(K) for a change in raw material of an existing device is based on several factors. some examples are Change in material type, formulation, chemical composition, or the material’s processing, the type of contact with the body, biocompatibility concerns, and effect performance specification by considering all these requirements one can decide whether a new 510(K) required.
I agree with the previous comments.
Subsequent software changes can be included under a Special 510(k), if the Traditional 510(k) submitted initially can identify the software verification and validation approaches. For the submission to be suitable for review as a Special 510(k), all test methods used to support the 510(k) should be well-established.
Please refer https://www.fda.gov/media/99785/download for more details on 510(k) for software change to existing device.
Raw material supplier changes that only modify the reference number or brand name of raw materials and do not change the raw material itself can go for a Special 510(k). But, a new 510(k) is needed if the raw material itself is changed.
Please refer https://www.fda.gov/media/99812/download for more details regarding 510(k) for change to existing device.