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.”
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.
- Code of Federal Regulation. (2012, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U. S. Government Printing Office.
- Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
- Devine, C. (2012). Devine guidance for complying with the 93/42/EEC – the European Medical Device Directive. Charleston, SC: Amazon.
there are ZERO FDA Inspectors licenses to carry guns. That is a complete hoax for many years now. This is due to the fact, that the U.S. Public Health Service (i.e. one of the 6 uniformed military our country has) work through FDA which gives this appearance, somehow, of holding firearms.
The U.S. Marshals, when required for FDA to fulfill their duties under different circumstances, WILL carry the firearms for the FDA Inspectors.
Just wanted to clear that up, as a former FDA Inspector myself, who gets asked this questions from various medical device companies from around the World. Completely untrue.