Question
If you receive an NSE letter from the FDA, you have four options for correcting the problems and resubmitting your device to the FDA. However, you want to avoid receiving a second NSE letter for the same FDA.There are four causes for receiving an NSE...
If you ask “how much less documentation is required for the design of a Class 1 device compared with a Class 2 device?” you get a very different answer. Instead of 0% (Yes a DHF is required) of 100% (No DHF required), the answer is that you need 33% ...
Most regulatory experts work on medical device OR in vitro diagnostics--not both. Making the switch from one type of 510(k) to another is not that hard.First, the submission content and format requirements are the same. There are still 20 sections, a...
A year ago, the panel of medical and academic experts at the US Policy Network’s annual meeting said that the fast-moving medical technology innovations are threatened by established interests and government regulations .The challenges of getting inn...
Hello everyone,What's the content of your DoCs? According to the EU Official Journal published in 2008, the required content are: "1. No xxxxxx (unique identification of the product): 2.Name and address of the manufacturer and/or his authorised repre...
After few years since the release of 2013/473/EU Commission Recommendation, I have the impression that the Unannounced audits are really becoming more and more frequent. Still, I haven't been able to find any publication discussing percentage of cove...
When writing a Hazard Analysis or FMEA, how much "pre-mitigated" control and design work can be assumed? The pre-mitigated risk level, which is used to drive design decisions, needs to be based on some "baseline" level of risk. But that "baseline" co...
The worst time to submit a pre-submission request is after you already started your verification and validation (V&V) testing. It’s too late because you are already committed to a testing plan. It takes 75-90 days for the FDA to schedule a pre-su...
3D medtech printing conference Maastricht presentation discussing 3D medtech printing under EU Medical Devices Directive and under future Medical Devices Regulation3D medtech printing under EU Medical Devices Directive and under future Medical Device...
Most countries have some kind of database for gathering adverse event data for medical devices, but most of these databases are not open to the public. The most common question I am asked is, “How do you access the Eudamed database?” for reporting of...
