Device industry: Purpose of 510(k) changes remains unclear

After consumer groups weighed in with their concerns over the FDA's proposed changes to the 510(k) process, it's now the industry's turn. In formal comments to the agency, trade association AdvaMed said the FDA hasn't made clear why the current guidance for evaluating substantial equivalence needs changing in the first place.

"Before proceeding, FDA should disclose the public health concerns associated with the existing guidance documents that the draft is intended to address," AdvaMed wrote in its comment, reported by MD+DI. Without knowing that, there's no way stakeholders can determine whether the new guidance is necessary and, if approved, whether it's effective.

The 510(k) process is designed to determine whether a new device is substantially equivalent to one already on the market, allowing for speedier approval. However, according to Johnson & Johnson ($JNJ), the FDA's proposed changes could result in prolonged review times and more rejections for candidate devices. AdvaMed also urges the FDA to conduct an economic analysis of the possible effect of the draft before proceeding.

All of that is in stark contrast to the views of consumer group Public Citizen, which last week claimed that the proposed 510(k) guidance will allow devicemakers to avoid efficacy-based trials for follow-on devices if regulators deem the changes minor, which could put unvetted products on the market.

- read MD+DI's report

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