The FDA has issued a total of 24 warning letters to the medical device industry for the fiscal year 2018. That is two WLs per month. WOW, that is AMAZING. With hundreds of inspections being conducted by the FDA, worldwide, such low number of warning letters would make one believe that the MEDICAL DEVICE industry has finally understood what it means to comply with the QSR/cGMPs. Further, it would appear that the FDA could reduce their manpower resources since the consumer protection is now being provided by the industry itself. This is what the mission of the FDA was to start with and it appears to have been achieved.
Or has it? In 46 years of FDA regulatory history, I have seen the FDA change regulatory policies multi-times. If you are familiar with the FDA, changing the laws and regulations is a very daunting task, needing Congressional approval and/or Federal Register announcements and industry comments. However, changing the FDA’s policies on how they enforce the regulations can change on a “DIME” (the dime is used because it is the smallest American coin).
Usually, the Congress (House of Representatives) provides the FDA’s oversight. They set the policy on how the FDA should regulate the industry. The Party in power takes the lead in the oversight committee and sets the agenda.
Many times over the years, we have seen major shifts in the FDA regulatory policies depending on which party was in the majority at the time. For example, in 2009, there was a new FDA Commissioner and the Democrats were in charge of the FDA oversight committee.
The then FDA Commissioner, Dr. Hamburg, stated that the FDA would expect full compliance in 15 days after an FDA-483 is issued. Companies had to show how they had addressed all inspectional observations within 15 days after receiving the 483. Prior to this change in policy, a company could provide a response to the FDA on how they were going to assure compliance in a reasonable time frame. This “new” FDA policy was impractical because there were many situations where it was impossible for a company to achieve compliance in three weeks. You may remember the number of warning letters at that time more than doubled and hit a new high of almost 200 by 2013. That is almost 10X the number issued in 2018.
So, has the industry finally seen the light and brought themselves into compliance in 2018? Or is it that the Republican-controlled oversight changed FDA policy accepting the industry’s voluntary compliance? The latter is probably a more reasonable assumption.
Is the consumer safety in jeopardy because of this new policy?
Another interesting development is the FDA accepting the MDSAP audits for companies in lieu of an FDA inspection. (MDSAP stands for Medical Device Single Audit Program).
This MDSAP program is a new auditing program that was trying to reduce the inspectional time for companies by having one audit performed by a certified body, that would include the quality system requirements of 5 countries, Canada, Brazil, Japan, Australia and the USA (still in draft). The EU is now looking to accept the MDSAP audit as well. The MDSAP audit is basically the ISO13485 plus each country’s special requirement. So, there would be one annual audit that covers all the regulations for all the listed countries, instead of having 5 separate audits (though Canada, Australia, and the EU were previously covered under the ISO13485 (CMDCAS audit already). As of now, Canada is the only country making the MDSAP audit mandatory by 2019.
I have been involved with both ISO audits and now the MDSAP audit and they are nothing like what an FDA audit used to be. The ISO audits were mainly documentation audits not device safety-related audits typically covered in the FDA inspection. Now applying 5 countries requirements to on audit is basically a JOKE when it comes to what is expected for a “Traditional” FDA QSR/cGMP audit.
So now, the FDA is asking companies if they have had or going to have an MDSAP audit. If you had this audit and you send this info to the Agency, the FDA will forego the FDA inspection. Is this consumer protection?
So, what is the FDA’s mission now? Does the FDA really believe that the industry does not need to be regulated? Does the FDA really believe that the MDSAP audit is a good substitute of a true FDA QSR/cGMP audit?
We have spoken to some FDA investigators during recent FDA audits, and that is not the feelings of the FDA’ers. The lack of issuance of warning letters makes them feel that they are not doing their job and they are concerned with the ultimate outcome of this policy. Their feeling about the MDSAP, all I could get is little snicker.
It used to be that when a company told an FDA investigator they were ISO13485 certified, the FDA would know where to look. In the FDA eyes, being ISO certified was not at the level of the QSR compliance requirements, especially as it related to the Design controls, complaint handling, and CAPAs.
So, where is the current state of things headed to? From the chart below, you will see that the number of warning letters issued to the industry has been falling off from the height in 2013. The regulatory pendulum swings back and forth as the changes in the oversight committee control take place. The problem is that the pendulum never seems to fall in the middle. You can be sure this current FDA policy of “voluntary” compliance is only temporary. Either, one of two things will happen: 1. there will be some major health-related incident that will cause the Congress to demand that the FDA tighten up their policies or 2. a change in Congressional makeup and regulatory policy will change for stronger FDA actions. This is not if but when. The industry will know when this will happen but the change in the FDA policy can change on the proverbial Dime, and the industry should not be surprised.
|Fiscal Year||No of Warning Letter|