Clarifying Medical Device Clearance

The FDA issued an update for certain documents governing the clearance of Class II medical devices and scheduled a public workshop on clinical trials.

The agency revised documentation for newly issued "special controls" guidance documents for the 510(k) market pathway for Class II devices in December 2008.

That move created confusion in the medical device industry, so the FDA is attempting to clarify its position on the binding nature of special controls guidance documents.

Special controls include "special labeling requirements, mandatory performance standards and post-market surveillance," according to the FDA's website. "In order to comply with the special controls guidance, manufacturers must address each identified risk to health presented in the guidance for the Class II device by either meeting the recommendations of the guidance or by some other means that provides equivalent assurances of safety and effectiveness," the FDA said.

The latest changes include clarifying the statement of the special controls guidance document's effect by replacing the standard language: "The firm must show that its device addresses the issues of safety and effectiveness identified in this guidance, either by meeting the recommendations of this guidance or by some other means that provides equivalent assurances of safety and effectiveness.".

The agency also announced plans for a public workshop on its clinical trial requirements.

The FDA designed the workshop, co-sponsored by the Society of Clinical Research Associates, to educate researchers on the FDA's role in clinical trials.

The two-day workshop is slated to include panels with FDA representatives on the relationships between FDA and clinical trial staff and institutional review boards, according to the agency.