Medical Devices Today

FDA Long-Term Globalization Strategy Under Development

Article preview from "The Gray Sheet" - February 14, 2011

Coping with an increasingly global device and drug industry will require a paradigm shift that relies less on FDA's own staff and more on data and resource sharing with other countries, the agency says.

"FDA Posts Criteria For Targeting Individual Execs As "Responsible Officers"

Article preview from "The Gray Sheet" - February 7, 2011

Almost a year after signaling its intent to target more executives with misdemeanor prosecutions when their companies have broken the law, FDA has published its criteria for pursuing such cases.

FDA 510(k) Reform Plan Yields Mixed Readings

Article preview from "The Gray Sheet" - January 24, 2011

Readings were mixed on what the ultimate impact will be on the medical device industry and on patient safety from FDA's 510(k) reform plan announced Jan. 19.

Industry Meets With FDA On Mobile Health Regulatory Plan

Article preview from "The Gray Sheet" - January 12, 2011

Members of the mHealth Regulatory Coalition representing the medical device, wireless communication and software industries met Jan. 10 with more than a dozen FDA staffers to discuss next steps for creating agency guidance on mobile health devices.

FDA's UDI Marching Orders: Don't Wait For The Regulation

Article preview from "The Gray Sheet" - December 6, 2010

The hoped-for regulation on FDA's unique device identification framework will not come out until the first part of 2011, but companies should start taking steps to implement UDI now, an agency official says.

Device Firms Weigh Pros And Cons Of FDA-CMS Parallel Review

Article preview from "The Gray Sheet" - November 22, 2010

As FDA and CMS edge closer to a joint program for pre-market review and reimbursement decision-making, device and diagnostic firms are expressing wariness about participating.

FDA Says Mela Sciences Device Needs New Study For Melanoma Detection

Article preview from "The Gray Sheet" - November 17, 2010

Mela Sciences should conduct a new study of its MelaFind melanoma detection system since the current data have not demonstrated "any true additive value" for its intended use, and the device "may potentially cause more harm than good," according to FDA reviewers.

FDA Recommends CT Scanner Changes To Prevent Radiation Overdoses

Article preview from "The Gray Sheet" - November 10, 2010

FDA wants makers of computed tomography scanners to revamp user information materials and training programs and tweak some software/hardware components to reduce the chance of radiation overdoses to patients.

Will Republican Takeover Of House Slow 510(k) Reforms?

Article preview from "The Gray Sheet" - November 8, 2010

The shift to Republican leadership in the House following the Nov. 2 election means the device industry will find a more sympathetic ear in Congress on 510(k) reforms and reauthorization of medical device user fees, device policy insiders say.

UDI By December? FDA Confident On Year-End Release Of Proposed Rule

Article preview from "The Gray Sheet" - November 1, 2010

FDA expects to lay out a proposed framework for mandatory unique device identification in December, though a final rule is at least a year away, according to Jay Crowley, senior advisor for patient safety at FDA.