LDT, BioCompatibility Final Guidance Make AdvaMed’s Priority List

March 27, 2015

The U.S. FDA should finalize guidance documents on premarket and postmarket data collection, the proposed laboratory-developed tests framework and adverse event reporting, and biocompatibility standards before attacking other priorities, AdvaMed says.

The suggestions come in response to a recent device center document listing priorities in guidance development (IDDM, Jan 9). The agency divided planned guidances into “A” and “B” lists in the report.

In comments posted recently to regulations.gov, AdvaMed urged the FDA to finalize all existing draft guidance for which the comment periods have closed as quickly as possible, but singled out the four documents on the center’s “A” list as particularly important to devicemakers. They are:

  • Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval;
  • Framework for Regulatory Oversight of Laboratory Developed Tests;
  • FDA Notification and Medical Device Reporting for Laboratory Developed Tests; and
  • Use of ISO 10993-1, Biological Evaluation of Medical Devices Part I: Evaluation and Testing (Biocompatibility).

The letter also asks the FDA to prioritize final guidance on human factors testing, exempting certain devices from 510(k) clearance, expediting access for devices intended to treat unmet needs and reprocessing devices in healthcare settings.

AdvaMed deemed most of the draft guidance the FDA plans to issue this year of medium priority, with the exception of one calling for the use of symbols in device labeling, which the group considers more important.

In addition, several documents not mentioned in the report should be considered high priority, the group said. These include updates to guidance on premarket approval modifications and manufacturing site changes, and device-specific guidance on codevelopment and nonmolecular types of multimarker panels. AdvaMed also wants to see an update of 2013 guidance on presenting risk-benefit information in space-limited internet platforms such as Twitter.

Eleven older guidances should also be reviewed and updated, AdvaMed said.

View AdvaMed’s comment at www.fdanews.com/03-30-13-advamed.pdf. — Elizabeth Orr