Devices
Three CDRH staff members are using a JAMA Dermatology editorial to give dermatologists an understanding of each of the different types of PMA (premarket approval) applications for new and modified Class 3 medical devices affecting dermatology. The article notes that with the increased awareness of skin conditions and demand for
Devices
A 1/10 CDRH Webinar reviewed three changes that were made between a draft and final guidance on technical considerations for additive manufactured medical devices (3D printing). CDRH Additive Manufacturing Working Group member Matthew Di Prima said the changes were made in response to 294 comments from 29 commenters on
Devices
A continuing resolution (see earlier story) that ended the government shutdown and sent FDA staff back to work also included a two-year suspension of the medical device excise tax. The tax was the brainchild of the Obama Administration and was intended to help offset Obamacare healthcare expenses. “This suspension
Devices
The International Medical Device Regulators Forum, which includes FDA, has issued a proposed document, “Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices,” to harmonize the documentation and procedures that are used to assess whether a medical device conforms to the regulations that apply in each
Devices
FDA has cleared a Techlab 510(k) for the Campylobacter Quik Chek and the Campylobacter Chek tests to aid diagnosis of campylobacteriosis, one of the most common causes of diarrheal illness in the U.S. According to Techlab, the Quik Chek is a rapid diagnostic test that detects Campylobacter jejuni
Devices
FDA has cleared a Diazyme Laboratories 510(k) to market its EZ Vitamin D Assay for clinical chemistry analyzers. This liquid-stable, ready-to-use two reagent system measures total 25-hydroxy Vitamin D (25-OH Vitamin D2 plus 25-OH Vitamin D3) levels. The assay enables clinical laboratories of
Devices
FDA has cleared a Medrobotics Corp. 510(k) for expanding the use of the Flex Robotic System for robot-assisted visualization in general surgical, gynecological and thoracic procedures. “This clearance is a vital step in our commitment to minimize the impact of surgery by offering less invasive procedures through a
Devices
FDA has cleared a Surmodics 510(k) for its Telemark .014 inch coronary and peripheral support microcatheter, intended for use in complex coronary and peripheral lesions. The microcatheter combines Surmodics’ Xtreme composite shaft technology with a high-performance Pristyne hydrophilic coating to provide improved deliverability, kink resistance and lesion crossing,
Devices
FDA has approved a Qiagen PMA supplement extending the indications for use of the company’s Therascreen EGFR companion diagnostic to guide the use of Boehringer Ingelheim’s targeted therapy Gilotrif (afatinib) for first-line treatment of metastatic non-small cell lung cancer (NSCLC) with non-resistant epidermal growth factor
Devices
FDA has issued a draft guidance, Laser Products—Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56), describing the agency’s proposed approach regarding compliance with its performance standards for laser products. “Because conformance to certain comparable portions of IEC
Devices
FDA has cleared a Centric Medical 510(k) for the Cannulated Screw Internal Fixation System for use in foot and ankle reconstruction procedures. The company says the streamlined multi-component system is made of titanium alloy and comes in a variety of diameters and lengths (2.0, 2.5, and
FDA Policy/General
FDA has issued a draft guidance, Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C, to assist and provide recommendations about the use, content, and circumstances for issuing public warnings and public notifications for firm-initiated or FDA-requested recalls under 21 CFR Part 7, Subpart
Drugs
FDA says it believes the public would benefit from having recall information about FDA-regulated products as soon as possible, even if more agency evaluation and classification of a recall remains to be done. Office of Enforcement and Import Operations director Douglas Stearn writes in an FDA Voice blog post
Drugs
HHS and 15 other federal agencies say they are delaying for six months from 1/19 to 7/19 the general compliance date for 2018 revisions to the Federal Policy for the Protection of Human Subjects that is in a final rule published 1/19/17. A Federal Register notice
Devices
FDA has cleared an International Biophysics 510(k) for the FloPump 32 centrifugal disposable heart pump. The company says the single-use device is one of the smallest centrifugal pumps in the world at 32ml prime, and it is intended to be used in conjunction with the Maquet RotaFlow console.
Devices
FDA has cleared a Medtronic 510(k) for the Riptide Aspiration System for use in retrieving blood clots through the Arc catheter and restoring blood flow in patients experiencing blockage of an artery in the brain (ischemic stroke). The procedure involves inserting a catheter through an incision in the leg
Drugs
Three FDAers say many researchers are unaware of FDA regulatory science research opportunities and the need for collaboration. Writing in Trends in Pharmaceutical Sciences, the three say the agency has “multiple avenues for collaborative research including participation in public-private partnerships, working with consortia, implementation of research collaboration agreements with
Devices
An FDA safety alert is warning health professionals about Zoll Medical’s Zoll LifeVest 4000 Wearable Cardioverter Defibrillator due to concerns that the device may fail to deliver treatment to the patient if the device is not replaced soon after displaying a “call for service” message code 102. Failure to
Devices
The Government Accountability Office (GAO) says FDA should develop and use performance metrics to evaluate its implementation of the requirement that it consider the least burdensome means of evaluating a medical device. FDA commissioner Scott Gottlieb says he agrees with the findings of the GAO report. The report describes (1)
Devices
CDRH says its strategic priorities for 2018-2020 are (1) employee engagement, opportunity, and success; (2) simplicity; and (3) collaborative communities. The Center’s strategic priorities document says the employee priority recognizes the connection between taking care of Center employees and achieving the Center’s vision. Simplicity is about how
Devices
The Department of Justice (DoJ) says a second individual has pleaded guilty in connection with a scheme to defraud consumers by selling laser devices as a treatment for more than 200 different diseases and disorders. A department news statement says Irina Kossovskaia, of Ontario, Canada, pleaded guilty in South Dakota
Devices
Sens. Edward Markey and Elizabeth Warren (both D-MA) have reintroduced legislation (S. 2287) to eliminate the 2.3% excise tax on medical devices. The tax first took effect 1/2013 as part of the Affordable Care Act. Congress suspended it for 2016 and 2017, but it was reinstated 1/