PDFs of presentations from the September 14, 2016 RAPID Think Tank are now available.
The Food and Drug Administration (FDA) joins the Medical Device Single Audit Program’s Regulatory Authority Council in encouraging medical device manufacturers to participate in the Medical Device Single Audit Program (MDSAP) Pilot. The Medical Device Single Audit Program is expected to begin transition to full implementation on January 1, 2017.
What is Medical Device Single Audit Program (MDSAP)?
As envisioned by the International Medical Device Regulators Forum (IMDRF), the FDA developed MDSAP in collaboration with regulatory authorities from Australia, Brazil, Canada, and Japan. IMDRF recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale.
MDSAP enables medical device manufacturers to contract with an MDSAP-authorized Auditing Organization (AO) to conduct a single audit against the relevant medical device regulatory requirements of all fully participating regulatory authorities. For more information about the Medical Device Single Audit Program, please visit the FDA MDSAP Pilot Webpage.
In an effort to help inform the medical device manufacturing community about MDSAP, the FDA posted ten new medical device education modules to the CDRH Learn Program website: Postmarket Activities | Inspections – Global Harmonization.
See also Endovascular Today
For immediate release August 24, 2016
The RAPID group included members from academia, industry, and the U.S. Food and Drug Administration.
MDEpiNet PPP was formed in 2013 to find new approaches to health information infrastructure and analytic methodologies that could promote better clinical and regulatory science. The Duke Clinical Research Institute (DCRI) serves as the coordinating center for MDEPiNet PPP, which includes representatives from academia, patient groups, payers, industry, government, and professional societies. The DCRI’s Mitchell Krucoff, MD, serves as principal investigator of the Coordinating Center.
“The primary focus of MDEpiNet is to facilitate dialogue across stakeholders in disease-specific and device-specific working groups,” Krucoff said. “These groups facilitate identification of unmet needs and priorities for particular patient groups and devices, together with novel, pragmatic, approaches to developing solutions.”
One of MDEpiNet’s most active working groups is the Registry Assessment of Peripheral Interventional Devices (RAPID), which is focused on devices used to treat PAD. Patients with PAD, a disease in which atherosclerotic plaque builds up in the arteries supplying the legs, initially experience pain with walking, but more severe disease can lead to limb loss. The condition can be treated with a number of different methods, including combinations of medical therapy, invasive catheter-based procedures, and surgical bypass grafting. There are many kinds of interventional devices used, such as balloons, stents and atherectomy systems (to remove plaque), not all of which are approved by the U.S. Food and Drug Administration (FDA) for PAD treatment.
“There is a real lack of knowledge,” said the DCRI’s James Tcheng, MD, chair of RAPID’s Informatics Working Group. “There is no uniform clinical description of the myriad ways in which patients can manifest PAD. There is no common lexicon among device manufacturers. And the fact that PAD treatment often involves three different kinds of physicians—interventional cardiologists, interventional radiologists, and vascular surgeons—makes things even more complicated.”
With co-chairs from academia, industry, and the FDA, the RAPID working group was tasked in Phase I of the project to develop a minimum core data set related to evaluation of the devices used to treat PAD patients. In Phase II of the RAPID program, the core data set will be implemented in several of the nation’s largest electronic health record and professional society registries in PAD. In Phase III this structured data content and access will be utilized in a prospective clinical trial.
“This has been a very inclusive process,” said Robert Thatcher, co-chair of the RAPID project. “All of us from industry who focus on PAD solutions have been invited to participate in the design and development of RAPID. Most are involved and those who are not at this point are still invited to join. Our goal from the beginning is to advance the science behind the treatment of PAD while making sure all voices have been heard. By doing this we end up in the best possible place to effectively treat PAD over time.”
Identifying and defining a minimum set of core data elements to be publicly shared involved a blend of clinical and informatics expertise. Leading the effort to define these data elements was RAPID’s Clinical Work Group, chaired by the DCRI’s W. Schuyler Jones, MD. Working from a list of more than 4,000 existing data elements complied from pivotal device trials and national registries case report forms, the Working Group distilled and vetted a final list of around 100 unique PAD device data elements.
With the data elements identified and defined, the Informatics Work Group added the parameters and attributes needed by computer systems to make them interoperable and interchangeable between information technologies such as electronic health records (EHRs) and clinical data registries. This work will also facilitate the long-term follow-up of patients treated with these devices and lead to improvements in treatments of PAD across the lifecycle of interventional devices.
A third group, the Unique Device Identifier (UDI) group chaired by Terrie Reed, the senior advisor for UDI Adoption in the FDA’s Center for Devices and Radiological Health (CDRH). This group develops methods to extract information from the FDA’s Global Unique Device Identification Database (GUDID) so that registries, EHRs, and others can leverage the FDA’s reference source of device information.
“The RAPID project has helped all participants to better see the value of working together to integrate UDI data from GUDID into device registries,” Reed said. “It is very rewarding to see the result of effective teamwork.”
“RAPID is a unique example of non-competitive collaboration by multiple medical specialties and device manufacturers that is critical for our patients,” Jack Cronenwett, MD, of the Society for Vascular Surgery/Vascular Quality Initiative. “It will lead to much more efficient vascular device evaluation using multiple sources of real world data, consistent with the FDA vision.”
CDRH Director Jeff Shuren, MD, JD, added, “This is an important step toward establishing the National Evaluation System for Health Technology.”
When finalized, this draft document will clarify for industry, FDA-accredited issuing agencies, and FDA staff the requirements under 21 CFR 801.40. Specifically, this draft guidance defines the expected content and forms of the Unique Device Identifier (UDI), to assist both labelers, as defined under 21 CFR 801.3, and FDA-accredited issuing agencies, as defined under 21 CFR 830.3, to better ensure the UDIs developed under systems for the issuance of UDIs are in compliance with the Unique Device Identification System Rule, 78 FR 58786 (September 24, 2013) (UDI Rule).
Today, the U.S. Food and Drug Administration released a draft guidance document on the Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. This draft guidance clarifies how the FDA determines that real-world data may be sufficient for use in premarket and postmarket regulatory decisions, without changing the evidentiary standards we use to make those decisions. It clarifies how we plan to evaluate real-world data to determine whether it may be sufficiently relevant and reliable for various regulatory decisions, and it also clarifies when an Investigational Device Exemption (IDE) may be needed to prospectively collect and use real-world data for purposes of determining the safety and effectiveness of a device.
Real-world data, which are collected from sources outside of traditional clinical trials, can provide powerful insight into the benefits and risks of medical devices, including how they are used by health care providers and patients. The draft guidance gives generalized examples taken from actual uses of real-world data as valid scientific evidence for various regulatory decisions.
This draft guidance is a cornerstone of our strategic priority of creating a national evaluation system for medical devices. That system would build on and leverage the vast amount of data and information collected during the treatment and management of patients.
We welcome comments regarding this draft guidance. The notice of availability will be published in the Federal Register on 7/27/16, and the docket for receiving comments will be open for 90 days from that date.
If you have general questions about this guidance, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2041, 301-796-7100 or firstname.lastname@example.org.