H.R. 3580 Proposals

Originally Published MDDI July 2002

DEVICE REGULATION

COMBINATION PRODUCTS

The bill addresses, once again, the problem of combination products—something SMDA tried to fix over a decade ago. The problem this time is that the new answer is not much different from the current system. The FDA Ombudsman's office (reporting to the commissioner) currently has the responsibility to designate lead centers for combination products—in addition to playing referee between industry and the agency.

The new bill simply creates a separate office for such designation with slightly more responsibility for coordination and advocacy of these product applications. I don't believe this proposed system will improve things. What is needed is a conceptually simple process, and clear assignment of responsibilities and resources.

Amongst all the FDA centers, CDRH deals with the most multidisciplinary products. CDRH culture and the laws it enforces have a greater degree of flexibility than the others handled by FDA. The centers for drugs and biologics both have excellent scientific core competencies in their areas of authority. But the key technical core competencies in CDRH are broader and more varied. In addition to the traditional device-related competencies such as engineering, materials, software, etc., CDRH core competencies include some of the scientific disciplines that underpin drugs and biologics, particularly in the Office of Science and Technology.

CDRH director David Feigel has a strong drug and biologics background. CDRH, therefore, is the appropriate home for an Office of Combination Products. It should be given a direct line of responsibilities for all combination products other than two specific cases: new biologics or chemical entities that could be stand-alone products, or cases when a well-proven device, such as a syringe, is involved with a drug (e.g., prefilled drugs in syringes).

Another area that requires attention is those products sold as stand-alone devices (e.g., blood bags or blood collection or processing equipment), but are used with blood or biologics. While the device laws are applicable to these products, they have been administratively assigned to the biologics center. The same is true of some in vitro diagnostic assays. These products are clearly medical devices and belong in CDRH so that interpretation of the laws and regulations for these devices can be the same as that for other devices.

STRENGTHENING THIRD-PARTY REVIEW

The proposal in H.R. 3580 to allow third-party review of all 510(k) applications is an appropriate one. If FDA has concerns about a certain device, the proposal allows it to exempt that device from third-party review so it can perform that review itself.

So that FDA's direct resources may be leveraged more effectively, however, it would be useful for the agency to issue more review guidelines on the performance of individual types of products and their validation. This would ensure that third-party review can truly become an extension of the agency. Given the right kind of performance by third-party reviewers, this system can be extended beyond 510(k)s as well. Therefore, additional provisions related to third-party reviews should also include the following:

AUGMENTING RESOURCES

Device fellowships are a great idea now, just as they were 25 years ago, when FDA borrowed the Staff Fellowship Program from NIH. As one who benefited from the program (I was the first senior staff fellow in FDA), I am surprised that new legislation is required for this purpose. Perhaps resources may be easier to obtain if Congress highlighted this program.

Retaining external experts and having accredited persons conduct third-party inspections are also great ideas. The proposal would require FDA to audit the performance of accredited persons on a regular basis. It may be useful for Congress to require FDA to issue reports along the lines of the annual report of FDA's Office of Device Evaluation, in which the cost and performance metrics of these third-party reviewers, whether for product approvals or plant inspection, is made available to help device companies choose appropriate reviewers.

BREAKTHROUGH TECHNOLOGIES

The emphasis on breakthrough technologies in the bill is laudable; the proposed remedy is weak. Once again, this is an issue revisited. FDAMA included a "fast track" for products that addressed unmet clinical needs for serious or life-threatening conditions. Nevertheless, the need for a mechanism to get quick access to breakthrough technologies remains unmet.

Unfortunately, the mechanisms proposed in H.R. 3580 to address breakthrough technologies are also designed for failure. The proposal, if enacted, would reduce the statutory time frames for review of breakthrough technologies from the current 180 days to a proposed 120 days. Even if one had faith in actual review times being the same or less than statutory time frames, this is not likely to result in time savings. H.R. 3580 would introduce another front-end bureaucratic process—designating a device for "priority" status.

This front-end process will be an added burden and, if experience with a similar triaging process currently in place for combination devices is any indication, it may take months. Though the request for designation could be made early on, even before the clinical investigation begins, it is unlikely that early submissions will be possible. Generally a product becomes a breakthrough product when there is some clinical evidence that it has some remarkable effectiveness against some serious condition.

Rather than have an unnecessary upfront process to examine individual products for a "breakthrough" category, FDA should be required to publish periodical lists of device types that would automatically achieve this status.

FDA, on its own or in response to citizen petitions, would keep adding to this list. FDA could have a general policy that the first, or the first two, PMAs of a totally new device type should be automatically classified as breakthrough. In addition, if a company requests it, FDA would grant or deny priority status at the time of a decision on the IDE for a product—without asking for additional information. This process would serve as a classification process for these breakthrough technologies.

In his strategic vision for CDRH, Feigal has proposed an FDA involvement in the entire product cycle, from concept to manufacturing and commercial use. If there ever was a place for FDA's involvement in the entire product cycle, it is for breakthrough technologies and products.

In the original amendments of 1976, there was a mechanism called the product development protocol. With this protocol, there was supposed to be close communication between the applicant and the agency from the early stages of product development to launch. Unfortunately, the mechanism never really got institutionalized, partly because of FDA's discomfort about too close a partnership with manufacturers.

Aggressive use of some such mechanism would be a good way to address breakthrough technologies. A collaborative program under the Collaborative Research and Development Agreement (CRADA) with organizations like the Office of Science and Technology in CDRH during the early states of the development process could also be useful. Congress could provide incentives for such collaboration through direct funding of collaborative R&D programs between FDA and industry. These would be used to develop some of the underpinning testing and validation methodology for breakthrough products.

OTHER REQUIREMENTS

Additional requirements in the proposed bill represent a potpourri of cleanup items, as follows:

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