Op Ed: Comments on How to Fix FDA, Per IOM’s 510(k) Review

Add a product review that requires design controls for Class II and Class III devices. The review should examine the following:

FDA can manage criteria for the technical file review using its guidance, but the risk management system should carry the greatest weight. This would allow the GHTF approach (which is already widely used by industry for international markets) to be used for FDA clearance, standardizing the review process across all departments.

Allow submission of audit reports to FDA for review, and let this be used as a NEW framework to replace 510(k) clearance.

Refocus FDA Inspectors to solely investigate postmarket incidences and Medwatch reports, in cooperation with other countries. FDA needs help and cooperation with other countries on enforcement. This would give FDA visibility into all manufacturers worldwide (allowing native speaking auditors to perform audits to inspection criteria the FDA helped draft at GHTF and ISO). Reports would have to be translated into English.

Continue and improve border control to ensure imported devices are coming from registered firms. The registration numbers (issued to registered companies) should be tied to labeling requirements (UDI), so border control can allow it quick entry into the market and facilitate handling post market activities

Make establishment registration easier, and free—otherwise all other countries will reciprocate with registration fees. FDA could begin to use, the newly available global accreditation system for ISO 13485 under IAF oversight and accreditation. ANSI/ANAB would liaise with FDA and other IAF Accreditation Bodies worldwide to monitor and improve the entire surveillance system worldwide. FDA establishment registration should be free and simple. Other countries reciprocate to FDA and if all countries followed the FDA “Establishment Registration” model, many smaller companies would be forced to pay for what could amount to a 100 different registrations.

Asking a company to tell you where it is and what it makes should be simple and inexpensive. It’s no more costly than submitting information to the Internet and it is where all FDA risk based priority assessments must begin. Encouraging registration helps FDA set its priorities. The focus needs to be on protecting the public, not funding FDA by taxing $1000 out of a medical device instrument manufacturer. Allowing more medical device firms to compete supports innovation. Who wants to pay $1000 for a blue ray player? Where quality is sufficient, price becomes the feature that spreads innovation.

Only charge a fee for clearance of new Class II or higher devices, since this will require more FDA Office of Device Evaluation resources. ISO 14155 for clinical investigations should be used and improved as necessary.

Use a primary standard to meet essential principles ISO 16142. FDA should put its resources into further development and use of ISO 16142, which should become the foremost medical device standard for showing how to meet GHTF essential principles using other standards. It needs more work to make provisions for using other standards (e.g. allow use of FDA recognized standards, where applicable).

Continue to consider substantial equivalence. Many so-called new medical devices are incremental improvements on older devices. The car we drive today is not that much different than 50 years ago. Despite the rancor about how to clear emerging technologies, truly innovative technologies account, at best, for only 2% of the devices entering the market each year. As such, substantial equivalence is a valuable tool. Which would you trust more, a device that is like one you have used for the last 10 years, or one that is a radical departure? In reality, we all know that substantial equivalence is a reasonable tool. Europe applies it through risk management assessments under ISO 14971. Postmarket information from existing devices is used as a basis for establishing low probabilities of occurrence of harm and to substantiate the safety of similar features in new products. Making newer devices based on older successes is commonplace. Adding feature creep toward improvements in performance and lower costs should not be penalized by ignoring the importance of substantial equivalence.

Embrace subtle innovations. Subtle leaps in innovation are where companies and FDA should focus attention. For devices in which the risk to health is low, the burden for proving the innovation’s worth should not be too onerous. Subtle innovations can often be assessed with some in-vitro (lab testing) studies and certainly should not require more costly clinical studies. Involving reviews of the innovations by clinicians, and some hands on testing can often be used successfully to substantiate the value and safety of many innovations.

Global Medical Device Nomenclature(GMDN) Code Overhaul and Use

If risk classifications were applied from GHTF (A, B, C, D) to each GMDN code, it would make the codes far more valuable, and industry and regulators would be more willing to use them. Risk classifications should also be periodically revised, to account for experience gained from post market data.

FDA got some things right. FDA product code is an ideal example the rest of the world should follow. In fact Canada and Japan have followed in the FDA’s footsteps. Product codes are free, and traceable to well-considered risk classifications.

Recognizing the cost of recognized standard. FDA has allowed some standards to be recognized without weighing the cost to industry. For example, removing IEC 60601-1 2nd edition and replacing it with IEC 60601-1 3rd edition seems like a minor, incremental change from reading the cover. It is however going to cost 10’s of thousands of dollars more, if the FDA suggests that it should be used to assess the general safety of electrically powered medical devices.

It is ironic that the FDA offers a $3000 fee reduction for a 510(k) review for small business, but an ODE reviewer may ask for a test reports to certain standards that can add up to $50,000. Even though the ODE reviewer has no concept of what is required to meet the standard. Some of these standards now appear in FDA Guidance for 510(k), and imply they must be met. The cost of meeting one standard, is now as high as employing someone.

In affect, we are seeing misunderstood (ill considered) standards, with very high costs, taking a huge toll on small and medium size companies, leading to losses in jobs and innovation. This is one of the most costly, abused and excused approaches used by the FDA.

Note that small and medium size companies are not involved in standards development. Many standards that are developed are intended to resolve issues with high risk devices, which account for only 10% of the medical devices on the market.
 

The ideas expressed in this opinion are not necessarily those of MD+DI or UBM Canon.