In a perfect world, there are no taxes, Cuban cigars are legal, good bourbon is always free, and the San Jose Sharks finally win Lord Stanley’s Cup. Unfortunately, this world is far from perfect and the medical device industry even more so.
There’s just one takeaway for this week: be meticulous and thorough in the preparation of the PMA. FDA considers PMA devices high risk, and as such, expect an entirely new level of detail versus the 510(k) process.
FDA premises device classification based on risk: Low-risk devices are Class I and high-risk devices are Class III. Then, just maybe, Class II is medium-risk? Well, sort of.
Although the regulatory burden is greatly reduced for Class I devices, manufacturers of Class I devices are still required to register their establishment with FDA, list their device(s) in the FURLS, and maintain general controls.
Although the regulatory burden is greatly reduced for Class I devices, manufacturers of Class I devices are still required to register their establishment with FDA, list their device(s) in the FURLS, and maintain general controls.
In FDA speak, the phrase “failure to define” is code for “your organization has screwed up and missed something!”
In FDA speak, the phrase “failure to define” is code for “your organization has screwed up and missed something!”
The seizure process is just a tiny bit more complex than having U.S. Marshalls kicking in the doors and backing up and loading the proverbial turn-up truck. However, seizure is one of the more powerful tools in FDA’s compliance tool chest.
The seizure process is just a tiny bit more complex than having U.S. Marshalls kicking in the doors and backing up and loading the proverbial turn-up truck. However, seizure is one of the more powerful tools in FDA’s compliance tool chest.
The concept of detention, employed by FDA, is not unlike the pain associated with the after school detention of this doctor’s wayward youth.
The concept of detention, employed by FDA, is not unlike the pain associated with the after school detention of this doctor’s wayward youth.
This is the 21 st Century and if a device manufacturer has not figured out that gauges need to be calibrated and traceable to a national standard, e.g. NIST, then the device manufacturer is probably in the wrong business.
This is the 21 st Century and if a device manufacturer has not figured out that gauges need to be calibrated and traceable to a national standard, e.g. NIST, then the device manufacturer is probably in the wrong business.
When your friends from the agency stop by for that friendly cup of coffee and an inspection, they will ask to see DMRs and, eventually, review DHRs to verify finished medical devices are being properly manufactured.
When your friends from the agency stop by for that friendly cup of coffee and an inspection, they will ask to see DMRs and, eventually, review DHRs to verify finished medical devices are being properly manufactured.
Instead of attempting to rationalize why your current approach to identification and traceability is acceptable, just bite the bullet and script a high-level SOP.
Instead of attempting to rationalize why your current approach to identification and traceability is acceptable, just bite the bullet and script a high-level SOP.
