Regulatory Open Forum

• Sterilisation cycle optimisation & validation - no phase separation
• Leachables/extractables
• Drug product stability - minimum 6 months long term/accelerated, assuming highly stable, would enable maintaining current shelf-life of 24 months at a push with extra data provision during review.

• Sterilisation cycle optimisation & validation - no phase separation
• Leachables/extractables
• Drug product stability - minimum 6 months long term/accelerated, assuming highly stable, would enable maintaining current shelf-life of 24 months at a push with extra data provision during review.

Dear Roy,

You do not mention any important functions of the syringe/applicator, other than the Primary Packaging function for which you have identified testing to assess impact.  The determination of these functions (e.g. deliverable dose or dose accuracy) could provide important testing to verify that no impact on performance. Also, an assessment on the impact of the change on the usability could be required (particularly if the ergonomics/forces change) or patient risk would be prudent, which may identify additional required testing.  You also do not mention whether the applicator is the part that fulfills any functional role on providing for a safe or effective application and/or whether this is part of the change (or a separate product).  If separate, certainly impact on deliverable dose, attachment force and possible leakage are elements that could be assessed/compared.

Overall the delivery function of this product must meet the Essential Requirements of Annex 1 of the MDD now, and/or the General Safety and Performance Requirements (GSPR) in Annex 1 of the MDR after May 2021.  Information supporting compliance must be in your technical file (or dossier).  If before May 2021, an assessment of the products conformance with applicable requirements (e.g. ER Checklist) will be need to be submitted.  After May 2021, a notified body opinion as to the conformance with the GSPR will need to be submitted.

It is my recommendation to identify the functions performed by this product and assess compliance of the modified product with the above mentioned requirements.  This exercise is critical for identifying and ensuring the impact of any change is properly evaluated and justified as acceptable.  

If this product has been on the market for a while, it is possible that none of this was done on this product or information provided to support the original submission. In that case, it will not be comparative, but a fully required exercise before submission. 

Lee Leichter

President

P/L Biomedical

10882 Stonington Avenue

Fort Myers, FL 33913 USA

Office: +1-239-244-1448

Cell: +1-239-994-6488

Email: leichter@plbiomedical.com