Devices & Diagnostics Letter

CDRH Friday released two guidances aimed at clarifying the center’s appeals process and bringing it in line with last summer’s FDA Safety & Innovation Act.

The FDA has stepped up its inspections of devicemakers over the last four years, resulting in a steep increase in warning letters, a new report finds.

Goldman Sachs last week announced plans to invest about $20 million in Indian devicemaker BPL Medical Technologies, marking one of the largest medtech investments made to date in an emerging market.

A new warning letter to Hospira’s Lake Forest, Ill., facility cites 12 findings related to its infusion pump manufacturing.

Healthcare providers experience the most frequent battery problems with large-volume infusion pumps and would like manufacturers to add green, yellow and red LED lights that change color when the battery status changes.

Oral arguments in a case challenging the SEC’s conflict minerals rule have been delayed after a ruling in a separate case showed the challenge needed to be moved to the U.S. District Court for the District of Columbia.

The China Food and Drug Administration (CFDA) has drafted two measures aimed at expediting approval processes for medical devices.

Australia’s Therapeutic Goods Administration is recommending to move forward with a proposal that would increase the number of mandatory audits for high-risk devices, make transparent all device regulatory decisions and allow all but Class IV in vitro diagnostic devicemakers to use non-TGA conformity assessments.

The FDA has approved Roche’s Cobas EGFR mutation test as the first companion diagnostic to spot epidermal growth factor receptor gene mutations.

Devicemakers may focus on developing products with stronger payer appeal in light of ongoing U.S. healthcare reforms, a recent survey suggests.