Folks, this week’s guidance is being typed out at 35,000 feet as Dr. D travels to Miami, on Memorial Day (remember freedom is never free). In this edition of DG, the doctor is going to provide a brief parody on the little differences and nuances between FDA and your friendly notified bodies. Now the doctor will be the first to admit he is an old guy. That being said, I have fond memories of one of my favorite comedians, the late George Carlin. Years ago, for those that can remember that far back, old George did a very creative comparison between football stadiums and baseball parks. It was hilarious.  Although medical device regulatory and quality compliance is often a dry topic, I will attempt to make the comparison between FDA and the notified bodies entertaining. For the notified bodies and members of the agency, please do not take offense with this week’s DG as it is just the doctor’s attempt at humor. In general, Dr. D hopes the readers are “sentient” and appreciative of the doctor’s humor. Enjoy and let the comparisons begin.

Viva la difference

The FDA performs inspections for the purpose of determining compliance to federal regulations; and if necessary, collects evidence that could be used in court. Can you say Form 483 observation? Notified bodies perform audits, identify opportunities for improvement, and issue non-conformances to drive corrective action.

If a device manufacturer fails to respond to a Form 483 observation, a warning letter is issued. If a device manufacturer fails to respond to a nonconformance, a courtesy telephone call and subsequent email is sent by the notified body.

If a device manufacturer fails to address the warning letter concerns, FDA can use the Department of Justice and the Federal Courts to drive compliance. Can you say Consent Decree? Can you name your Chief Jailable Officer (CJO)? If a device manufacture fails to respond to their notified body’s request for corrective action, their certificates are suspended and/or revoked. However, kissing and making up with the notified body, including a group hug and a verse of Cumbia, is considerably more forgiving then a smooch with FDA. The agency is far-less forgiving.

FDA investigators carry a badge and a few are licensed to carry firearms. The notified body auditor carries a business card.

FDA inspections are paid courtesy of the American taxpayer and establishment registration fees. Device manufacturers contract with and pay their notified bodies for the performance of their audits and sometimes, the subsequent pain.

The FDA charges an arm and a leg for the review of Pre-Market Approval (PMA) submissions (Class III devices) and a relatively tidy sum for 510(k) submission reviews (Class II devices). In comparison, the notified body review fees are reasonable for Design Dossiers (Class III) devices.

Once clearance is received for a Class II or Class III device in the US, it is basically on the market for the life of the device, providing the device continues to be safe and effective and is not racking up the MDRs. In Europe, depending on the notified body, Class III devices must be renewed every three to five years. These reviews are not free. If the devices sold in Europe are racking up the vigilance reports, the Competent Authorities, from impacted Member States, will get involved.

Note: the Competent Authorities are starting to bare their teeth and show some fangs. So many more comparisons are possible but the doctor has so little time as the intercom of the Boeing 777 blares out; “Ladies and gentlemen it is time to turn-off and stow your electronic devices.”

Takeaways

In closing, the doctor hopes you have found this week’s brief guidance to be entertaining. If device manufacturers are doing the right things in regards to compliance, then a visit from FDA should never be feared but always respected. As for the notified bodies, they should always be respected; however, if you are not pleased with your notified body, you are always free to change to another.

In closing, thank you again for joining Dr. D and I hope you find value in the guidance provided. Until the next installment of DG – cheers from Dr. D. and best wishes for continued professional success. 

References: 

1. Code of Federal Regulation. (2012, April). Title 21 Part 820: Quality system regulation.  Washington, D.C.: U. S. Government Printing Office.
2. Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
3. Devine, C. (2012). Devine guidance for complying with the 93/42/EEC – the European Medical Device Directive. Charleston, SC: Amazon.