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Medical Devices

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Legal experts representing the clinical decision support (CDS) software industry take strong issue with FDA's draft guidance on CDS software, published Dec. 7.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

December 14, 2017 | Daily News

FDA Commissioner Scott Gottlieb on Monday (Dec. 4) announced the agency will establish a regulatory framework for how it regulates nontraditional manufacturers of 3D-printed medical devices.

December 07, 2017 | Daily News

FDA and CMS will increasingly work together on simultaneous diagnostic test reviews, a move that FDA Commissioner Scott Gottlieb told lawmakers Thursday (Dec. 7) could serve as “a powerful incentive” for more sponsors of diagnostic tests to voluntarily go through the FDA approval process.

December 07, 2017 | Daily News

FDA on Thursday (Dec. 7) took steps to fulfill the digital health provisions in the 21st Century Cures Act by issuing a suite of guidances that reveal which clinical decision support (CDS) tools won't be considered devices.

December 07, 2017 | Daily News

FDA last week approved the first medical device cleared for use with the Apple Watch following a 19-month review process largely due to the complexity and potential risk of the product's software, which can interpret diagnostic tests without any physician involvement.

December 05, 2017 | Daily News

FDA published final guidance Monday (Dec. 4) aimed at helping CMS determine which investigational devices to cover by streamlining the categorization of investigational device exemption (IDE) products -- completing a process launched in 2015 through a Memorandum of Understanding (MOU) between FDA's device center and CMS' Coverage and Analysis group (CAG).

November 30, 2017 | Daily News

CMS on Thursday (Nov. 30) canceled the Episode Payment Models and the Cardiac Rehabilitation Incentive pay model, and it shrunk the mandatory Comprehensive Care for Joint Replacement demonstration after about half of hospitals participating in that mandatory model earned payments from CMS when preliminary data showed they were below benchmark spending for the model's first year.

November 30, 2017 | Daily News

For the second time, CMS agreed to cover a companion diagnostic on the day FDA approved it.

November 28, 2017 | Daily News

FDA Commissioner Scott Gottlieb and National Institutes of Health (NIH) Director Francis Collins will testify in front of the Senate health committee on Thursday (Dec. 7) regarding progress being made by FDA and NIH in implementing the 21st Century Cures Act.

November 27, 2017 | Daily News

The House Energy & Commerce health subcommittee will examine FDA and the National Institutes of Health's implementation of the 21st Century Cures Act at a hearing Thursday (Nov. 30) where the heads of both agencies will testify.

November 21, 2017 | Daily News

The White House is asking Congress to appropriate $7.6 million in additional FDA funding for hurricane recovery, namely to pay for repair of the agency's offices in hurricane-affected areas.

November 21, 2017 | Daily News

Amsterdam was chosen Monday (Nov. 20) as the new seat of the European Medicines Agency in the wake of the United Kingdom's earlier vote to exit the European Union.

November 15, 2017 | Daily News

FDA has approved marketing approval of a device -- the first of its kind -- that can help provide patients with relief from opioid withdrawal systems, the agency announced Wednesday (Nov. 15).

November 15, 2017 | Daily News

FDA may withdrawal a regulation related to drug irradiation and requirements that certain medical device submissions be submitted via paper copy, HHS Associate Deputy Secretary Charles Keckler told a House Oversight subcommittee during a Tuesday (Nov. 14) regulatory reform hearing.

November 08, 2017 | Daily News

A coalition of patient advocacy, research and surgeon groups penned letters to House and Senate leaders on Wednesday (Nov. 8) urging them to permanently repeal the medical device excise tax, which is set to go back into effect in January 2018.

November 08, 2017 | Daily News

FDA has significantly reworked portions of its guidelines relating to medical device manufacturers' sharing of patient-specific information with individual patients upon their request.

November 06, 2017 | Daily News

FDA announced Monday (Nov. 6) that the agency would exempt from premarket review all in vitro tests marketed to consumers for detecting genetic risk of developing a disease, so long as manufacturers have received a first-time FDA marketing authorization for their systems.