Regulatory Open Forum

Hi I am explaining to my RD/Quality team that there is a high probability that our polymer coating supplier we are sourcing our polymer for a class III combination product (drug eluting device) will likely be audited by FDA as part of the Pre-approval inspection.

Several reasons:

1. We have never submitted a PMA as a manufacturer

2. it is a new novel polymer developed by a supplier that the FDA has not visited before

3. the top coating is most likely considered non-compendial expcipient since it the portion (coating) that assist in the drug elution 

4.this supplier does not have a MAF and they are providing us the documentation for the manufacturing section of the PMA; however, based on above, I do believe that this supplier is critical and will most likely be audited, based on what I provided here

5.. this supplier is not registered with the FDA, they are very small. (yes , this might be another issue)

I could really use some assistance in examples or where in the regulation it states this supplier would be subject to an audit once the documentation was reviewed within the PMA manufacturing section (assuming we receive the documentation and that the review proceeds to a PAI).

I also think that our team is putting the cart before the horse in that we have other priorities on development and documentation without worrying about something maybe 2 years down the road, but I want to make sure I answer this question now since it keeps coming up.

The MAF guidance suggest the supplier could be audited since they are creating two different polymer coating for us- base and topcoat and of they had a MAF or a product that would require one, they could be subject to an audit. 

Of course the Supplier controls and purchasing controls must be followed; however, since this is a new business, and a new polymer developed for us and they do not have a MAF for either base coat(existing) or top coat; my thinking is they will be audited by the FDA assuming the documentation submitted in the PMA is sufficient.

"Good Manufacturing Practice Regulations for Medical Devices

Organizations or persons who submit IDEs, 510(k)s, or PMAs, or other device-related submissions to FDA may use contract manufacturers, sterilizers, packagers, etc., in the manufacture of their devices. The latter, for trade secret or confidentiality purposes, may submit a description of its facilities, manufacturing procedures and processes, and quality control procedures in an MAF rather than provide this information directly to the client for inclusion in its submission.

In their evaluation of the client's submission, FDA may inspect the MAF holder's facilities and manufacturing operations. When the MAF holder's operation is subject to the Good Manufacturing Practice (GMP) regulations for medical devices (21 CFR 820), the MAF must address all appropriate GMP requirements applicable to the MAF holder's operation. A client's submission may be adversely affected if the MAF is incomplete or inaccurate. This is especially true in the case of a PMA because of the statutory requirement that a PMA contain a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and when relevant, packing and installation of the device. "

Plus the drug eluting stent guidance also suggest the polymer (excipient)supplier could be audited. I have been using this guidance as well as the new combination guidance as a resource even though we are not developing a DES, but our product does elute a drug and has a polymer base and top coat so it has a lot of good information

Does anyone have any links/ideas that would assist me in providing a stronger response to my team.?

your assistance is appreciated.
Regards

Hi I am explaining to my RD/Quality team that there is a high probability that our polymer coating supplier we are sourcing our polymer for a class III combination product (drug eluting device) will likely be audited by FDA as part of the Pre-approval inspection.

Several reasons:

1. We have never submitted a PMA as a manufacturer

2. it is a new novel polymer developed by a supplier that the FDA has not visited before

3. the top coating is most likely considered non-compendial expcipient since it the portion (coating) that assist in the drug elution 

4.this supplier does not have a MAF and they are providing us the documentation for the manufacturing section of the PMA; however, based on above, I do believe that this supplier is critical and will most likely be audited, based on what I provided here

5.. this supplier is not registered with the FDA, they are very small. (yes , this might be another issue)

I could really use some assistance in examples or where in the regulation it states this supplier would be subject to an audit once the documentation was reviewed within the PMA manufacturing section (assuming we receive the documentation and that the review proceeds to a PAI).

I also think that our team is putting the cart before the horse in that we have other priorities on development and documentation without worrying about something maybe 2 years down the road, but I want to make sure I answer this question now since it keeps coming up.

The MAF guidance suggest the supplier could be audited since they are creating two different polymer coating for us- base and topcoat and of they had a MAF or a product that would require one, they could be subject to an audit. 

Of course the Supplier controls and purchasing controls must be followed; however, since this is a new business, and a new polymer developed for us and they do not have a MAF for either base coat(existing) or top coat; my thinking is they will be audited by the FDA assuming the documentation submitted in the PMA is sufficient.

"Good Manufacturing Practice Regulations for Medical Devices

Organizations or persons who submit IDEs, 510(k)s, or PMAs, or other device-related submissions to FDA may use contract manufacturers, sterilizers, packagers, etc., in the manufacture of their devices. The latter, for trade secret or confidentiality purposes, may submit a description of its facilities, manufacturing procedures and processes, and quality control procedures in an MAF rather than provide this information directly to the client for inclusion in its submission.

In their evaluation of the client's submission, FDA may inspect the MAF holder's facilities and manufacturing operations. When the MAF holder's operation is subject to the Good Manufacturing Practice (GMP) regulations for medical devices (21 CFR 820), the MAF must address all appropriate GMP requirements applicable to the MAF holder's operation. A client's submission may be adversely affected if the MAF is incomplete or inaccurate. This is especially true in the case of a PMA because of the statutory requirement that a PMA contain a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and when relevant, packing and installation of the device. "

Plus the drug eluting stent guidance also suggest the polymer (excipient)supplier could be audited. I have been using this guidance as well as the new combination guidance as a resource even though we are not developing a DES, but our product does elute a drug and has a polymer base and top coat so it has a lot of good information

Does anyone have any links/ideas that would assist me in providing a stronger response to my team.?

your assistance is appreciated.
Regards