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Medical Devices

March 06, 2018 | Daily News

FDA Commissioner Scott Gottlieb on Tuesday (March 6) spotlighted the agency’s efforts to reform the premarket review process for diagnostic tests, and he previewed next steps, which include qualifying third-party reviewers and third-party databases to help with reviews and approvals, reducing regulatory burden on next generation sequencing (NGS) developers, and providing flexibility in clinical analysis and validation.

March 06, 2018 | Daily News

FDA on Tuesday (March 6) granted marketing authorization -- with special controls -- for the first time for a direct-to-consumer (DTC) genetic health report detecting whether users are at risk of developing breast and ovarian cancer.

February 22, 2018 | Daily News

Presented with compelling evidence, FDA will allow device sponsors to sidestep a requirement that companies demonstrate their clinical investigations -- conducted both inside and outside the United States -- followed good clinical practices (GCPs), including human subjects protections, the agency announced in a final rule released Tuesday (Feb. 20).

February 13, 2018 | Daily News

The head of Blue Cross Blue Shield Association's clinical evaluation, innovation and policy shop questions whether FDA's proposed software precertification program -- which would allow certain companies to take new medical software to market more easily -- will offer adequate clinical evaluations of safety and effectiveness.

February 13, 2018 | Daily News

Should the president's budget hike for FDA get ratified, the agency would spend the extra $400 million dollars on: creating Centers of Excellence for compounding and digital health, researching continuous manufacturing, standing up third-party certification of medical device quality, advancing near-real-time evaluation of real-world evidence, expanding the digital health precertification program, conducting natural history studies for rare disease, and creating new internal agency systems for knowledge management and generic drug submission, according to FDA Commissioner Scott Gottlieb.

February 13, 2018 | Daily News

The head of the Blue Cross Blue Shield Association questions whether FDA's proposed software precertification program -- which would allow certain companies to take new medical software to market more easily -- will offer adequate clinical evaluations of safety and effectiveness.

February 12, 2018 | Daily News

Advocates for robust funding of FDA were pleased the president's fiscal 2019 budget released Monday (Feb. 12) calls for a 13 percent increase over fiscal 2018 continuing resolution levels.

February 08, 2018 | Daily News

FDA, working with the Nuclear Regulatory Commission, approved NorthStar Medical Radioisotopes' RadioGenix System, a “novel manufacturing system” to produce a non-uranium version of radioisotope technetium-99m (Tc-99m), a diagnostic agent used in nuclear imaging studies to detect cancer and coronary artery disease, FDA and Commissioner Scott Gottlieb announced in simultaneous press statements on Thursday (Feb. 8).

February 02, 2018 | Daily News

The nine major medical device and technology companies selected by FDA last fall to be a part of the agency's digital health pre-cert pilot program praised the agency and the program at a two-day public workshop held this week at the National Institutes of Health.

January 29, 2018 | Daily News

An FDA expert panel rejected Philip Morris International’s claim that its smokeless tobacco product, IQOS, could reduce users’ risk of tobacco-related disease, but the experts did approve of the company's claim that the product would reduce a user's exposure to harmful chemicals.

January 26, 2018 | Daily News

CMS tells Inside Health Policy it is exploring new ways to provide patients timely access to emerging technologies after axing a proposed rule that had been sitting at the White House budget office since April.

January 12, 2018 | Daily News

FDA announced on Friday (Jan. 12) that it will continue to delay until further notice a controversial regulatory measure that would factor “the totality of the evidence” into agency decisions regarding a drug or device manufacturer's intended use of a product and communications about such uses.

January 12, 2018 | Daily News

FDA Friday (Jan. 12) significantly delayed the date by which class I and unclassified devices must bear a unique device identifier (UDI).

January 11, 2018 | Daily News

In 2018, FDA will focus on making the process for developing and approving biosimilar drugs more efficient, modernizing its own internal processes and technologies, and developing a comprehensive plan to encourage development of healthy foods, the agency announced in its 2018 Strategic Policy Roadmap released on Thursday (Jan. 11).

January 11, 2018 | Daily News

In 2018, FDA will focus on making the process for developing and approving biosimilar drugs more efficient, modernizing its own internal processes and technologies, and developing a comprehensive plan to encourage development of healthy foods, the agency announced in its 2018 Strategic Policy Roadmap released on Thursday (Jan. 11).

January 04, 2018 | Daily News

The National Health Information Sharing and Analysis Center's Threat Intelligence Committee has alerted the healthcare sector to two new cybersecurity threats, the NH-ISAC TIC announced Thursday.

December 29, 2017 | Daily News

Legal experts representing the clinical decision support (CDS) software industry take strong issue with FDA's draft guidance on CDS software, published Dec. 7.

December 28, 2017 | Daily News

FDA from 2008 to 2014 saw a roughly 500 percent increase in the number of premarket submissions that include patient-reported outcome (PRO) measures, but there are still challenges the agency needs to tackle when it comes to incorporating PROs into device approvals, including enhancing training, transparency and expertise, and reducing sponsor uncertainty, according to the agency's first PRO report released Dec. 12.

December 21, 2017 | Daily News

FDA is seeking nominations for patient advocates to participate in a Patient Engagement Collaborative (PEC), which will bring FDA and the patient community together to discuss patient engagement in medical product development and other regulatory issues, the agency announced in the Federal Register on Wednesday (Dec. 20).

December 14, 2017 | Daily News

FDA is planning a number of deregulatory moves in 2018, including expanding access to some drugs currently requiring prescriptions without the intervention of a health care provider, so long as they are coupled with safe guards to aid in self-selection and safe use, the agency announced in the White House Office of Management and Budget's Fall 2017 Unified Agenda released Thursday (Dec. 14).

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