Industry Takes Aim At Several Proposals In FDA’s 510(k) Report – Comments

Article preview from "The Gray Sheet" - October 6, 2010

Device manufacturers are lining up against a number of FDA's proposed reforms to its 510(k) pre-market notification process, saying they could harm, not help, the agency’s public health mission.

Industry Takes Aim At Several Proposals In FDA’s 510(k) Report – Comments

By Jessica Bylander

Device manufacturers are lining up against a number of FDA's proposed reforms to its 510(k) pre-market notification process, saying they could harm, not help, the agency’s public health mission.

FDA's device center released preliminary reports in August on reforming the 510(k) program and incorporating new science into regulatory decision-making. Comments were due Oct. 4.

Combined, the reports offered more than 50 recommended changes to the 510(k) process, and industry comments take aim, in part, at the sheer volume of the proposed changes.

"It's not in the best interest of patients to implement so many changes that it would likely overwhelm the agency and the industry," Stephen Ubl, president and CEO of AdvaMed, said in Oct. 5 comments.

Device makers support a few of the concepts in FDA's report – namely, improving review training to make device reviews more consistent, publishing more timely guidance documents, and establishing a new Center Science Council to ensure consistency in device reviews and provide expertise on challenging scientific questions.

But manufacturers take issue with other FDA proposals to consolidate the pre-market terminology "intended use" and "indications for use" into one broad concept, to consider off-label uses of devices when determining the actual "intended use" of a product, to conduct pre-clearance manufacturing inspections as part of 510(k) reviews, and to limit the number of predicate devices a manufacturer may rely on in a single 510(k) submission.

Intended Indications

Rather than lump the terms "intended use" and "indications for use" together, AdvaMed recommends revising guidance to clarify the meaning of each term, and training reviewers on how to distinguish between them.

The Medical Imaging and Technology Alliance agrees that the concepts are fundamentally different and should not be combined. "These terms have different meanings," MITA writes in Oct. 4 comments. "The intended use of a system describes the general use for which a system was developed. The indications for use of a system refer to the more specific clinical applications of a device."

Off-Label Uses

The trade associations and various individual firms also agreed that FDA does not have the right to consider off-label uses as the primary intended use for a device, or to change pre-market requirements accordingly.

In cases where FDA believes the primary use of a cleared device would be an off-label use, the agency is proposing to consider the off-label use in its 510(k) review and not the use proposed by the sponsor.

According to the Medical Device Manufacturers Association, "such a modification would improperly extend FDA's authority into the regulation of the practice of medicine."

Strict laws against off-label promotion by device manufacturers and even physicians provide enough safeguards against the practice, according to the National Venture Capital Association in Oct. 4 comments.

Allowing FDA reviewers, rather than manufacturers, to decide the intended use of a product "would make the 510(k) process completely unpredictable," NVCA states. "Every reviewer would be allowed to speculate on potential off-label uses for a device."

Other Issues: Class IIb, Predicates

In separate comments, AdvaMed raised concerns about FDA's proposal to divide the current Class II device category in two, with added pre- and post-market requirements for higher-risk, so-called "Class IIb" devices. AdvaMed and orthopedic device maker Biomet support the general idea of singling out some Class II devices for additional requirements, but without creating the formal Class IIb category described by FDA.

MDMA, however, said FDA should continue making decisions on which Class II devices require more clinical or manufacturing data on a case-by-case basis.

FDA and manufacturers are also butting heads on the appropriate use of multiple predicates.

The agency is proposing to limit the number of predicates a manufacturer could use in a single 510(k) submission, and to completely forbid the use of "split" predicates in a submission – that is, the use of one predicate with a similar intended use, and another predicate with similar technological characteristics.

Device makers say the proposed limits would be too restrictive. Multiple predicates are "absolutely essential to innovation," MDMA writes. And, there has been no data to suggest they lead to patient harm, the group maintains.

After reviewing the comments on the two reports, FDA says it will decide which proposals to move forward and provide additional information and opportunities to comment.

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