Hi all...

We are considering (very preliminary at this point) making a formulation change to an existing 510k registered product. The potential change would be a concentration of the formulation. Based on the reading I am doing I would consider this to be a significant change even if the indications and product specifications remain the same. I am leaning towards filing a special 510k as the user would have significantly different instructions (resulting in a package insert and instrument change) and the associated risk factors may vary. Can anyone either support or refute this decision based on their knowledge or experiences? Thanks in advance for all of your help! I would really appreciate any feedback.

Sarah

Hi all...

We are considering (very preliminary at this point) making a formulation change to an existing 510k registered product. The potential change would be a concentration of the formulation. Based on the reading I am doing I would consider this to be a significant change even if the indications and product specifications remain the same. I am leaning towards filing a special 510k as the user would have significantly different instructions (resulting in a package insert and instrument change) and the associated risk factors may vary. Can anyone either support or refute this decision based on their knowledge or experiences? Thanks in advance for all of your help! I would really appreciate any feedback.

SarahHave you gone through the flow charts (http://elsmar.com/Forums/attachment.php?attachmentid=2234&d=1086891677)? I believe a performance change requires a 510(k) if you need clinical data to establish safety & efficacy.

Hi all...

We are considering (very preliminary at this point) making a formulation change to an existing 510k registered product. The potential change would be a concentration of the formulation. Based on the reading I am doing I would consider this to be a significant change even if the indications and product specifications remain the same. I am leaning towards filing a special 510k as the user would have significantly different instructions (resulting in a package insert and instrument change) and the associated risk factors may vary. Can anyone either support or refute this decision based on their knowledge or experiences? Thanks in advance for all of your help! I would really appreciate any feedback.

Sarah

Hi Sarah,

Welcome to the Cove. :bigwave:

Regarding your query, a special 510(k) may be acceptable. However, the change can only be addressed in a special 510(k) if certain requirements are met. For eg., a change in formulation in a material or a change to a type of material that has been used in other legally marketed devices within the same classification regulation for the same intended use could be reviewed as a Special 510(k). This should be true for both non-contacting devices as well as implants and devices that contact body tissues or fluids.11

Also if you refer http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=320.21 , it clearly states the following -

(c) Any person submitting a supplemental application to FDA shall include in the supplemental application the evidence or information set forth in paragraphs (a) and (b) of this section if the supplemental application proposes any of the following changes:

(1) A change in the manufacturing site or a change in the manufacturing process, including a change in product formulation or dosage strength, beyond the variations provided for in the approved application.

(2) A change in the labeling to provide for a new indication for use of the drug product, if clinical studies are required to support the new indication for use.

(3) A change in the labeling to provide for a new dosage regimen or for an additional dosage regimen for a special patient population, e.g., infants, if clinical studies are required to support the new or additional dosage regimen.

Hope this helps.

Thanks Al and Quality,

I have read both of the suggested documents and I still feel like I am in the "gray" area. The potential change doesn't quite fit into any of the categories described and when I use the flow chart I feel like there are big judgement calls that could go either way. I think this probably means I need to go ahead and file the special 510(k). Thanks again for your suggestions.

Sarah