Medical Device Import Entry Review Process

Hello!

The device industry in the US continues to wonder what will become of the 510(k) process.  Senator John Kerry of Massachusetts has written a letter to FDA Commissioner Dr. Margaret Hamburg raising concerns that the medical device industry has over potential changes to the 510(k) process.  You can read more about his letter here: http://tinurl.com/3wyoqsw

FDA raised more concerns and sowed seeds of confusion in the medical device industry by publishing a letter about the import entry review process. (see http://tinyurl.com/4rqlg3r)  I too was confused and so contacted the Center for Device and Radiologic Health (CDRH) for clarification.  Turns out there is nothing new about the process and all that CDRH wanted to say is that imported devices can clear FDA’s border inspections faster if the paperwork includes the A of C code for the medical device being imported.

When importing a medical device into the US, the accompanying entry information should identify the product and include appropriate information to demonstrate that the product is in compliance with FDA regulations. When importing devices you must provide the following information:

1. Foreign manufacturer number (obtained from FDA when the manufacturer registers with FDA)
2. Listing information (Listing of the devices the company manufactures—this is done in conjunction with the registration process.)
3. Identity of the initial importer
4. The 510(k) or PMA number for the device

All of this information is communicated by the A of C codes and FDA’s March letter was simply trying to convey that the AofC codes are very helpful to the agency—so what is an AofC code?

AofC stands for ‘Affirmation of Compliance’.  Use of the code conveys the information listed in 1-4 above but goes further—the importer is pledging, affirming, swearing, that the product meets all FDA requirements specific to each code. So the good news is that you may be able to expedite entry of your devices into the US.  The bad news is that there are some devices that do not have AofC codes.  The codes can be found at the end of FDA’s letter.

My associates and I hope that your product is successful whether you are importing your device or manufacturing it in the US.  Contact us with your regulatory needs be it registration, listing or 510(k) or PMA submissions.

Learn more about the services we offer at www.BioTransApp.com.

Regards,

Evelyn

Liquid and Semi-solid Foods and Dietary Supplements

On March 3, 2011 FDA published a final rule that amended 21CFR 113, which regulates ‘thermally processed low acid canned foods in hermetically sealed containers” to allow the use of ‘temperature indicator devices’ other than mercury filled glass thermometers.  So why am I telling you about this?  Partly because what the agency calls ‘canned foods’, which brings to mind metal containers and possibly glass jars, also refers to other aseptically processed foods and beverages. But I tell you about this mostly because this modernization from mercury filled glass thermometers is not the agency’s only recent alertness to this general sector of regulations. You see, the sister regulations for ‘thermally processed low acid canned foods’ are regulations covering the production of ‘acidified foods’-- foods which are not aseptically processed because their pH is low enough to prevent spoilage.

So what?  Well, you and I and FDA have noticed many more liquid dietary supplements in the marketplace.  Most contain acid ingredients and therefore are acidified foods. However, not all manufacturers comply with the regulations of 21CFR114, which require that they register their facilities as acid food producers and file the processes by which they assure that the product will not spoil and cause public harm. This registration is separate from the more generic food facility registration. I wrote about this once before in November of 2010 but I am raising the issue again because I continue to see liquid dietary supplements that have acidic components added to them but whose processes have not be filed with FDA.  Because this regulation is important for ensuring the safety of public health, any violation could cause your company to have to cease production until FDA approves your process and your entire Good Manufacturing Practices (GMP) program. 

I am also concerned about these sister regulations because I have seen a number of liquid ‘alkalinizing’ products on the market—they too would fall under one of these sets of regulations.  The guidance documents for these regulations are really hard to find on the FDA website and an FDA staffer in the office of Low Acid Canned Foods agreed that the regulations are difficult to understand; none the less, if you are producing a liquid or semi-solid product that is preserved in any way, you probably need to pay attention to this. 

If you have any doubt about which regulations apply to your products, contact us by leaving a comment. We are here help.

If you know what regulations apply to your product but need help complying with them—let us know.