The Center for Devices and Radiological Health (CDRH) recently issued its fiscal 2017 regulatory science priorities. The list repeats some of the points highlighted in its 2016 list, while surfacing some new issues for consideration.
Topics: CDRH, Regulatory Science Priorities, FY 2017
The Food and Drug Administration (FDA) has been working closely with Industry negotiators and other stakeholders for years to establish a National Evaluation System for medical devices. The goal of establishing such an infrastructure is to generate real world evidence to efficiently monitor the long-term safety and effectiveness of medical devices. In the FDA’s Center for Devices and Radiological Health (CDRH) strategic priorities report for 2016-2017, establishing a National Evaluation System for medical devices is a priority, however according to the CDHR Director, Dr. Jeffrey Shuren the system may not be ready until fiscal year 2023, if the agency cannot secure funding.
According to an article in The Gray Sheet, it mentioned that Dr. Shuren received assurance from the FDA’s Commissioner, Dr. Robert Califf that the agency will provide the initial funding for a coordinating center that would help build the system. However, the money will only be provided if additional funding is forthcoming from Congress or increased user fees, which are being negotiated in the Medical Device User Fee Act (MDUFA IV).
Topics: CDRH, NEST, National Evaluation System
There are many stakeholders involved in conducting a clinical trial today; however, there can be many challenges to the infrastructure of running a clinical trial. Challenges that are seen with running medical device trials can vary anywhere from securing funding to lacking
Topics: FDA, CDRH, Robert Califf, Clinical Research Associate
The number of original PMAs for completely high-risk devices and panel track supplements for major new updates approved by the FDA, was at its highest level since 2001. Approvals increased to 56% in 2015 compared to the previous year and almost double the 2013 total.
Topics: FDA, CDRH, William Maisel, User Fee, Paul LaViolette
On April 1st, the FDA issued a draft guidance that provides more comprehensive information for industry and CDRH on the processes associated with panel device meetings. The new draft guidance document, Procedures for Meetings of the Medical Devices Advisory Committee, pertains to the to 17 of the 18 Medical Devices Advisory Committee (MDAC) panels overseen by FDA's Center for Devices and Radiological Health (CDRH), the FDA center in charge of regulating medical devices.
Once finalized, the updated guidelines will replace a 2000 CDRH guidance document on the panel process and a 1991 blue book memo. Thus, the guideline clarifies the circumstances in which the CDRH consults with a device advisory panel, the conduct of panel meetings and the expected timelines to prepare for a panel meeting.
Topics: Medical Devices, Draft Guidance, FDA, CDRH
The Center for Devices and Radiological Health (CDRH) recently released an update on its 2014-2015 Strategic Priorities. This document summarizes the areas that CDRH is focusing on to ensure patients in the US have access to high-quality, safe, and effective medical devices. The current strategic priorities are: to strengthen the clinical trial enterprise, to strike the right balance between premarket and postmarket data collection, and to provide excellent customer service.
Topics: Medical Devices, Strategic Priorities, CDRH
The FDA’s device center (CDRH) has established time based performance standards to help ensure draft guidance documents do not remain in an unresolved state for too long. The following draft performance goals have been outlined:
Topics: FDA, CDRH, Performance Goals, Draft Guidances, Bradley Merrill Thompson
We ran across an interview with Owen Faris in The Gray Sheet, acting clinical trials director for CDRH. The position was established to help implement the several CDRH strategic priorities in 2014-15 that were announced in February focusing on speeding up the IDE review process and encouraging more IDE trials in the U.S.
Topics: CDRH, Clinical Research, IDE Approvals, Owen Faris
Why in 2013 was there
Topics: Medical Device Manufacturers, FDA, CDRH, Product Recalls
One of the results from the recent two-week government shutdown is a backlog of government submissions. Although during the shutdown, the FDA continued to review device submissions that were submitted prior to October 1st, the agency was prevented from accepting any new fiscal year 2014 user-fee funded device submissions, including PMAs and 510(k)s.
Topics: Government Shutdown, FDA Backlog, CDRH, Medical Device Industry
It is critical that the group of patients enrolled in a study represent the population that may receive the device once it is on the market. Certain medical devices could elicit different responses depending on gender, according to the federal watchdog agency. Basic differences such as genetics, hormones, body size, diet and socio-cultural issues may play a role in the efficacy of medical devices in patients, according to FDA.
Topics: Medical Devices, Health of Women Program, FDA, CDRH
Just released on FDA’s website concerning The Center for Devices and Radiological Health (CDRH) is a posting that reads “Data Standards and Terminology Standards for Information Submitted to CDRH” which is intended to benefit device manufacturers, hospitals, and clinical investigators. But what exactly are the benefits to data and terminology standards?
Topics: Standardized Terminology, FDA, CDRH
For quite some time we’ve watched the blame for slow review times pass between industry and FDA. One side claims the pathway to approval lacks transparency and predictability, the other claims the submissions are of poor quality. But could this coming year be the start of a new relationship between FDA and industry?
Topics: Medical Device Review Process, FDA, CDRH, MD+DI
With this year coming to an end it’s time to look back and review the past year and start making the “to-do” list for the upcoming year. FDA has already taken this initiative and recently posted their Strategic Priorities for 2013. We’ve summarized the priorities and the planned steps to complete these proposals.
Topics: Strategic Top Priorities, 2013, FDA, CDRH
For quite some time we’ve watched the blame for slow review times pass between industry and FDA. One side claims the pathway to approval lacks transparency and predictability, the other claims the submissions are of poor quality. But could this coming year be the start of a new relationship between FDA and industry? According to a new report on FDA’s website, the plan implemented in January 2011 aimed to modernize and improve the premarket review of medical devices is working. This development seems promising as the speed and predictability of medical device review has improved for the first time in almost a decade- according to FDA’s report.
Topics: Device Review, FDA, CDRH, 510(k)
In order to better understand the CDRH’s review of submissions that were found to be Not Substantially Equivalent (NSE), FDA published on its website the initial results of 510(k) audit as part of the Action Plan implemented in January 2011. The determination of NSE not only is an inefficient use of FDA’s time and resources, but can also be a costly delay for industry. With this information and analysis now available, the goal is for sponsors to understand the reasons the NSE determination resulted, as well add some clarification to the process.
