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In Case You Missed It: Top 10 Gray Sheet Stories In April

This article was originally published in The Gray Sheet

Executive Summary

A podcast interview and a feature story delving into the recent international ISO 13485 quality systems standard revision were the most popular items at TheGraySheet.com last month. Our continuing coverage of off-label communication questions in the courts and the laboratory-developed test debate attracted attention, along with a piece on biocompatibility testing tips from FDA officials. Also: popular Gray Sheet podcasts from April.

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FDA Biocompatibility Tips: Multiple Absorbability, Allergenicity Testing Methods To Choose From

An FDA device reviewer and an agency toxicologist talk to The Gray Sheet about key industry considerations for biocompatibility testing, emphasizing a growing focus on testing absorbable implants and testing for allergens in devices.

Don't Finalize LDT Guidance, House Appropriators Tell FDA

FDA should "suspend further efforts to finalize the laboratory-developed test guidance" and instead work with Congress on a new regulatory pathway for LDTs, House appropriators told the agency in an FY 2017 spending bill, which also adds $10 million to fight the Zika virus.

Lab Group Urges FDA To Wait For Congress On LDT Issue

Jeff Shuren recently spoke at the annual American Clinical Laboratory Association industry meeting where the device center director was grilled on FDA's plans to regulate lab-developed tests. While ACLA President Alan Mertz appreciates Shuren's willingness to engage, his group continues to push back hard against the agency's plan to move forward with a final LDT plan before Congress has a chance to act.

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