Regulatory Requirement Updates? Medical Device Contract Manufacturer

cubix rube

Involved In Discussions
We just completed our stage 2 for 13485, and were recommended for certification with 9 very minor non-conformances. I should start by saying that we are not a registered medical device OEM, but rather, a contract manufacturer that makes components for OEM customers. As such, any regulatory requirements not having been communicated to us by our customers, tend to go unnoticed here.

For example, our auditor pointed out that in our Q2 Management review, it was noted that "there are no new regulatory requirements that would affect our business." Our auditor mentioned some recent directive by the FDA pushing for the OEMs to exert more control over their contract manufacturers, and that this could very well affect our business. Now, the FDA may very well indeed notify the OEMs of such changes, but that rarely trickles down to us.

We are a very small company (25 employees), and do not have any sort of dedicated compliance officer, or anything like that.

Is there some sort of service to which we can subscribe, or something along those lines, that would notify us of any changes to regulatory requirements when they occur, so we're not left to just randomly pore through CFRs at some regular frequency looking for changes?

Any ideas would be greatly appreciated. Thanks!
 

pkost

Trusted Information Resource
I am in a similar situation and have not come across any service that will notify me of relevant changes to regulations - (we do use a service to alert us to changes with relevant standards). I'm not sure how google alerts would work but may look into it.

I find that the best way to be aware of changes to regulations is read industry magazines and maintain a good relationship with our suppliers, customers and other friends in the industry - that way you can get a heads up!

I would be tempted to point out to the auditor that the FDA regulations have not changed and that the directive is just a drive to encourage control that should already be in place!
 

somashekar

Leader
Admin
We just completed our stage 2 for 13485, and were recommended for certification with 9 very minor non-conformances. I should start by saying that we are not a registered medical device OEM, but rather, a contract manufacturer that makes components for OEM customers. As such, any regulatory requirements not having been communicated to us by our customers, tend to go unnoticed here.

For example, our auditor pointed out that in our Q2 Management review, it was noted that "there are no new regulatory requirements that would affect our business." Our auditor mentioned some recent directive by the FDA pushing for the OEMs to exert more control over their contract manufacturers, and that this could very well affect our business. Now, the FDA may very well indeed notify the OEMs of such changes, but that rarely trickles down to us.

We are a very small company (25 employees), and do not have any sort of dedicated compliance officer, or anything like that.

Is there some sort of service to which we can subscribe, or something along those lines, that would notify us of any changes to regulatory requirements when they occur, so we're not left to just randomly pore through CFRs at some regular frequency looking for changes?

Any ideas would be greatly appreciated. Thanks!
I would request you to see THIS thread and find more details in the attachment, and hope this gets you to have fuller awareness about cGMP requirements.
Wishing you well ~~~
 
M

MIREGMGR

For example, our auditor pointed out that in our Q2 Management review, it was noted that "there are no new regulatory requirements that would affect our business." Our auditor mentioned some recent directive by the FDA pushing for the OEMs to exert more control over their contract manufacturers, and that this could very well affect our business.

A brief daily visit to this website/forum may be the best way of keeping up-to-date with new rules, directives and other mandated actions.

Your problem, in a sense, is that you aren't directly subject to 99% of such rules and directives because of your business model.

You might want to adopt a practice of carefully wording your management review statements so that instead of referring to "no new regulatory requirements that would affect our business", you state "no new rules or guidances that are applicable to our company or that we anticipate will affect our business interactions with present and future customers". The FDA's regulatory requirement change and announcement process is relatively well publicized and not all that frequent. The 13485 world is a little bit more complicated because guidances come from a variety of EU organizations, but it's still manageable.

Our auditor mentioned some recent directive by the FDA pushing for the OEMs to exert more control over their contract manufacturers

As noted above, your auditor should be aware that this was only a statement or "suggestion", not a guidance. An FDA guidance is a formally developed, formally issued document.
 
D

DavidP

I am new to the 13485 standard as well. We are/will be a contract manufacturer of medical device components. I have been doing alot of research to be sure I have covered the bases. I did find a way to get updates. If you go to the FDA home page there is a link on the top right of the page to get e-mail updates. When you click on the link you need to create a profile and provide your e-mail. You will then get a list of topics you would like to get updates on. I selected Guidance Documents and Regulations, Laws and Standards. When you click on the Regulations, Laws and Standards you get a second menu where you should select FDA Data Standards. I have not received any updates yet which means nothing has changed. Hope this helps!
 
M

MIREGMGR

This is a good point...the FDA offers a number of subscriptions.

The most relevant to contract manufacturers, I think, is the one for Device Warning Letters. Regulation changes affecting contract manufacturers are likely to be in regard to interpretation, application, and inspection policy...none of which involve anything "new".

The most recent significant change regarding contract manufacturers was a year or so ago, when the FDA stated in a Warning Letter that when a contract manufacturer should have known (in the FDA's judgement) that their customer was not properly handling regulatorily required actions, the FDA will hold the contract manufacturer co-responsible for that shortfall. In the cited instance, the contract manufacturer "should have known" because they also made the same product for sale by themselves, and were a registered establishment and had listed the device toward that end. As far as I can tell, this was an evolved interpretation of the relevant rules, which in a plain reading doesn't say any such thing.

In another Warning Letter, the FDA stated that inspectors would conduct a QSIT inspection of a non-registered-establishment contract manufacturer, and hold that contract manufacturer co-responsible for any discovered shortcomings within the scope of their manufacturing task i.e. manufacturing record-keeping, having proper controls, etc., if a QSIT inspection of the contract manufacturer's customer indicates that they are not properly controlling the contract manufacturer and the product may post a risk to users. As far as I can tell, that was new policy based solely on an evolved interpretation, too.
 
Top Bottom