Weekly Device Summaries for June 28 - July 2, 2010

FDA to Publish Reform Plans Soon.  In the coming weeks, FDA intends to issue two long-awaited reports on reforming the medical device review and approval process.  The agency plans to issue a proposal for reforming the 510(k) premarket notification process and a proposal for reforming the way science is used in FDA regulatory decision-making.  The device industry is anxiously anticipating both reports, as industry representatives noted at a recent meeting with FDA leadership.  The proposals aim to make the medical device review and approval process more predictable, in response to industry concerns.  Additionally, FDA seeks to identify optimal methods for reviewing and approving devices of increasing complexity.                                                                                                                                      

Agencies Seek to Streamline the Marketing and Reimbursement Review.  FDA and the Centers for Medicare and Medicaid Services (“CMS”) have agreed to share information in an effort to aid companies seeking marketing approval from FDA and reimbursement for their devices from CMS.  Currently, FDA and CMS make the decisions separately.  Under the new agreement, however, CMS may begin assessing reimbursement for a device while it is still undergoing premarket review at FDA.  The agreement moves closer toward a parallel review process, whereby new devices would be reviewed for marketing approval and reimbursement simultaneously. 

New Regulatory Path Proposed for Novel Devices.  A group of venture capitalists has proposed a new FDA premarket review pathway for novel devices.  Under the proposal, FDA would formally define a “novel” device, and companies could submit requests to have their devices designated as novel.  FDA would be required to decide each request within 30 days, and novel devices would be reviewed in an expedited fashion by a team of experts.  Resources expended on the expedited review would be paid for by the company in the form of an extra user fee to the agency. 

Industry Input Sought for FDA Regulatory Science Initiative.  The drug and device industry should play a role in FDA’s efforts to improve regulatory science at the agency, according to FDA Commissioner Margaret Hamburg.  In a recent speech, Hamburg said industry should have a seat at the table as FDA and NIH work together to identify new methods and tools for reviewing medical products.  According to Hamburg, improving regulatory science at FDA will make premarket reviews more efficient and predictable. 

Weekly Device Summaries for June 21 - 25, 2010

IOM Holds Second Meeting to Discuss 510(k) Program.  The Institute of Medicine (“IOM”) recently held its second of three public meetings to evaluate FDA’s premarket notification (“510k”) program.  FDA has asked the IOM to assess whether the 510(k) program continues to protect and promote public health, amidst concerns that the program allows medical devices to reach the market too easily.  At the meeting, discussion focused on FDA’s enforcement capabilities for products cleared for marketing through the 510(k) pathway.  Some attendees claimed that FDA’s ability to address safety issues with 510(k) devices is limited, because FDA cannot revoke 510(k) clearance decisions.  The IOM will host its final meeting on the 510(k) program in July and intends to publish a report of its findings next summer.

Industry Questions FDA Requirement for Pediatric Data.  A rule instituted in March that requires device companies to provide FDA with information on pediatric use of their devices exceeds FDA’s authority, according to industry trade group AdvaMed.  In comments on the rule, AdvaMed contends that the law authorizing the rule only requires information on known pediatric uses of a device.  However, the March rule requires device companies to provide FDA with information on potential or possible pediatric uses of their devices, as well as the number of pediatric patients who might be treated with the device.  AdvaMed claims that the request for information on potential pediatric use oversteps FDA’s authority under the law, and is requesting that FDA withdraw the rule.  

FDA Devising Plan for Oversight of Laboratory Developed Tests.  FDA may have a regulatory framework in place soon for laboratory-developed tests (“LDTs”), though the agency previously did not engage in oversight of the tests.  LDTs are tests provided as a service by the same laboratory in which the test was created.  As such, FDA typically has not regulated the tests, relying instead on certification of the laboratories under the Clinical Laboratory Improvement Amendments to ensure the adequacy of the tests.  However, FDA claims to have authority to regulate the tests, and now intends to generate guidance documents outlining a risk-based approach for regulating LDTs.  As part of this effort, the agency will hold a public meeting on the topic in late July.

Weekly Device Summaries for June 14 - 18, 2010

FDA Exerts Authority over Genetic Tests.  FDA recently sent letters to firms making direct-to-consumer genetic tests, asking the companies to submit evidence of the tests’ accuracy, though the tests are already being marketed.  The companies argue that FDA has no authority to regulate the tests because they are laboratory-developed tests subject only to government oversight through the Clinical Laboratory Improvement Amendments.  FDA disagrees, however, claiming that the agency can require the tests to undergo premarket review because the tests are not developed and used by a single laboratory.  Direct-to-consumer genetic tests have come under heightened scrutiny in recent months, with leaders in Congress and the National Institutes of Health seeking increased oversight of the tests.

Industry Seeks to Improve Safety of Radiation Therapy Devices.  In conjunction with an FDA meeting on the topic, device firms have unveiled an industry-wide effort to prevent treatment errors during radiation therapy.  Under the “Radiation Therapy Readiness Check Initiative,” a working group from the industry trade group AdvaMed and the Medical Imaging & Technology Alliance would develop safeguards to help clinical staff use radiation therapy devices correctly.  Additionally, the Initiative would utilize three steps to ensure the correct dose of radiation is administered: pre-treatment quality verification checks, beam modification checks, and confirmation of correct patient positioning.  In the future, the Initiative may seek to build software-based checklists into certain radiation therapy devices. 

Medical Innovation Advocacy Group Issues New Report.  The Council for American Medical Innovation (“CAMI”) issued a report on June 10, 2010 that outlines a breakdown in the process of converting innovative medical research into marketed treatments and technologies.  As a result, the group is initiating a large-scale lobbying effort to improve federal activity related to medical innovations.  As part of this effort, the group seeks to enhance the predictability of the FDA regulatory process and improve FDA regulatory policy.  CAMI is also seeking increased funding for FDA and a federal office dedicated to medical innovation.  CAMI also hopes to increase private investment in medical innovation through tax incentives.

Weekly Device Summaries for June 7 - 11, 2010

FDA, NIH Discuss Synchronizing Clinical Trial Requirements.  In conjunction with the National Institutes of Health (“NIH”), FDA hosted a public meeting on June 2, 2010, to discuss how the two agencies could better communicate on issues of clinical trial design.  FDA and NIH are currently seeking to establish a joint leadership council, which would be tasked with speeding up the process of turning clinical research into new medical treatments.  In this regard, attendees at the meeting said that FDA and NIH need to harmonize their approach to clinical trials, such that research funded by NIH can be used to support swift drug and device approvals.  

Regulators Continue to Seek Improvement in Infusion Pumps.  As FDA proceeds with its initiative to improve the safety of external infusion pumps, the agency told manufacturers at a recent workshop that companies should focus on the user interface when designing the pumps.  According to FDA, user error in operating infusion pumps often is connected to the design of the user interface.  As a result, the agency is urging device makers to make the interfaces more user-friendly, suggesting that firms focus on the pump controls, the graphics displayed to the user, and the alarms on the pumps.  In addition to FDA’s initiative, representatives from international regulatory agencies noted at the workshop that similar problems have been found with infusion pumps outside the United States.  As a result, these regulators called for international harmonization of regulatory rules and postmarket surveillance for the pumps. 

FDA Publishing Decision Memos on Device Approvals.  As part of FDA’s new transparency initiative, the agency’s Center for Devices and Radiological Health (“CDRH”) has begun publishing summaries of agency decisions on devices recently approved for marketing.  Specifically, CDRH has posted on its website summaries of internal agency review memos for certain types of devices and approval applications.  Agency leaders have said that CDRH intends to soon begin posting decision memos for 510(k) premarket notifications.

Weekly Device Summaries for May 31 - June 4, 2010

Government Turns to Devices to Meet Public Health Need.  FDA, along with numerous other government agencies, has created a council dedicated to eliminating persistent public health problems through innovation in medical device development.  The Council on Medical Device Innovation is seeking to identify the most important unmet public health needs and the hurdles to developing new devices to meet these needs.  Then, the Council hopes to address any government barriers that are preventing such innovation.  The Council will hold its first public meeting on June 24, 2010 and will be accepting public comments until July 23, 2010. 

FDA Conducts Workshop on Infusion Pumps.  After announcing an initiative to improve the safety of external infusion pumps last month, FDA held a public workshop to obtain input on the initiative from the device industry and clinicians.  At the meeting, industry representatives noted that FDA’s new pre-market requirements for the pumps could improve safety but also hinder innovation by making it harder for improved designs to get to market.  Meanwhile, FDA urged hospitals and device makers to be more candid in reporting adverse events, to improve safety assessments for infusion pumps.  Additionally, FDA noted that this initiative may be a guide for future efforts to improve the safety of other device types. 

Group Says Radiation Equipment Should be Harmonized.  The Society for Radiation Oncology Administrators is asking FDA to require device manufacturers to share information, in order to increase the compatibility of radiation equipment.  The professional society, which is composed of hospital and oncology practice administrators, submitted comments to FDA on its effort to assess the safety of radiation therapy.  The Society said that hospitals utilizing equipment from different manufacturers often have to apply a “work around,” because proprietary concerns render the devices incompatible with one another.  FDA will seek industry input on the issue during a meeting with industry representatives on June 9, 2010. 

FDA Meeting Prompts Discussion of Wireless Home-Use Devices.  As part of FDA’s effort to improve regulation of medical devices used in the home, the agency held a public meeting to discuss upcoming FDA guidance on the topic.  Discussion at the meeting focused on the role of wireless devices, such as smart phones, that may communicate health information and are used in the home.  While some attendees questioned whether such devices are subject to FDA regulation, FDA representatives noted that if a malfunction of these devices would pose a risk to patients, the agency may get involved.  Other attendees noted that FDA regulation of wireless devices could pose challenging for the agency, as it would need to keep abreast of rapid developments in device technology.