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The FDA occasionally says something about the benefits of harmonization with EU MDD, but I'm not aware of any efforts to harmonize the medical device classification systems. Anyone else know of activity in that direction?
I'm mostly writing this post out of frustration. We have thousands of different drape-and-cover, patient positioning and fluid capture products, and I'm working on a major project to verify that our internal regulatory-compliance stance for each project is of course properly compliant with FDA and EU MDD requirements, but also does not exceed those requirements in ways that result in significant additional costs. This of course is driven by increased pressure to be cost-competitive. I'm frustrated at the inefficiency of having two disparate systems, each of which has some obviously justified advantages, many of which we cannot take advantage of because we must comply to both systems.
The FDA often categorizes procedural accessories per the classification of the primary procedural device or modality, which often results in irrational patient protection and product costs. Thus an equipment-contamination-prevention sterile disposable equipment drape used in an invasive-procedure sterile field, but well characterized as having no direct or indirect patient contact, nonetheless is a Class II MMP or KKX requiring an expensive 510(k) and sometimes requiring proof of an acceptably low degree of laser-ignitability even when the device's intended use precludes proximity to lasers. On the other hand, a body-cavity-invasive sterile disposable camera cover is a Class I FTT/FTH/KQM/FWE/FWD/FWC/FWB/FWI/FWH and receives essentially no oversight even though it theoretically should require a greater-than-minimum degree of ISO10993 biocompatibility compliance.
But, to its credit, the FDA sometimes (albeit inconsistently) utilizes Class I designations and GMP exemptions to focus heightened regulatory documentation requirements on devices with greater risk, which at least conceptually are grouped into Class II.
The EU, on the other hand, groups practically all medical drape & cover, patient positioning and fluid capture devices into Class I, irrespective of significant and well-known differences in their degree of risk. And, there are no exemptions. Everything requires the same degree of compliance...which is good in that they don't irrationally exempt a few riskier devices, but bad in that their requirements impose far more regulatory compliance costs for hundreds of low-risk products compared to the FDA...which in many instances prevents us from taking advantage of the FDA's lower-cost requirements.
Grrrrrrr.


I'm mostly writing this post out of frustration. We have thousands of different drape-and-cover, patient positioning and fluid capture products, and I'm working on a major project to verify that our internal regulatory-compliance stance for each project is of course properly compliant with FDA and EU MDD requirements, but also does not exceed those requirements in ways that result in significant additional costs. This of course is driven by increased pressure to be cost-competitive. I'm frustrated at the inefficiency of having two disparate systems, each of which has some obviously justified advantages, many of which we cannot take advantage of because we must comply to both systems.
The FDA often categorizes procedural accessories per the classification of the primary procedural device or modality, which often results in irrational patient protection and product costs. Thus an equipment-contamination-prevention sterile disposable equipment drape used in an invasive-procedure sterile field, but well characterized as having no direct or indirect patient contact, nonetheless is a Class II MMP or KKX requiring an expensive 510(k) and sometimes requiring proof of an acceptably low degree of laser-ignitability even when the device's intended use precludes proximity to lasers. On the other hand, a body-cavity-invasive sterile disposable camera cover is a Class I FTT/FTH/KQM/FWE/FWD/FWC/FWB/FWI/FWH and receives essentially no oversight even though it theoretically should require a greater-than-minimum degree of ISO10993 biocompatibility compliance.
But, to its credit, the FDA sometimes (albeit inconsistently) utilizes Class I designations and GMP exemptions to focus heightened regulatory documentation requirements on devices with greater risk, which at least conceptually are grouped into Class II.
The EU, on the other hand, groups practically all medical drape & cover, patient positioning and fluid capture devices into Class I, irrespective of significant and well-known differences in their degree of risk. And, there are no exemptions. Everything requires the same degree of compliance...which is good in that they don't irrationally exempt a few riskier devices, but bad in that their requirements impose far more regulatory compliance costs for hundreds of low-risk products compared to the FDA...which in many instances prevents us from taking advantage of the FDA's lower-cost requirements.
Grrrrrrr.


