Medical Device Blog – QA & Regulatory Updates from Emergo Group

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That\'s why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you. No fluff, just straight to the point. We hope you\'ll enjoy the content.

CDRH 2012 Strategic Priorities: Familiar Themes

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has published its 2012 Strategic Priorities, which include improvements to pre- and post-market processes, internal and external communications, and efforts to support innovative product development.

First, the regulator plans to complete implementation of its “Total Product Lifecycle Approach,” which entails taking into account “all of the relevant information available to the Center, at any stage of a product’s life cycle to assure the safety, effectiveness, and quality of medical devices,” according to the CDRH. This goal includes the following efforts:

Improving premarket reviews by better managing premarket review workloads; issuing proposed rules for when the CDRH could utilize clinical studies conducted in non-US markets; finalizing all guidances related to improving premarket programs; and evaluating CDRH staffing, infrastructure and policies related to medical software.
Addressing globalization challenges by participating in the first meeting of Global Harmonization Task Force successor the International Medical Device Regulators Forum, and by taking part in at least two harmonization efforts with non-US regulatory authorities this year.
Improve compliance capability by implementing “business-case-for-quality” initiatives such as best-quality manufacturing practices and determining further actions for 2013 as well.

Second, the CDRH plans to improve communication and transparency both among its internal staff and with various constituencies—patients, industry groups and health care providers.

Externally, the CRDH will enhance information exchange capabilities, improve feedback gathering and also establish a national forum for discussions with constituents.
Internally, standard operating procedures for information sharing among staff will be established.

Third, the CDRH intends to improve its workforce in terms of both employee education and satisfaction. For example, the division plans to launch its Experiential Learning Program (ELP) to improve staff knowledge of device design and manufacture, as well as its CDRH Leadership Enhancement and Development Program (LEAD) to improve managers’ and supervisors’ performance.

Fourth, the regulator plans to boost innovation to better meet public health needs as well as improve regulatory science.

Supporting innovative device development through initiatives including the Entrepreneurs in Residence program and Innovation Pathway 2.0 this year.
Developing personalized medicine programs by issuing guidance on Companion Diagnostics and co-development of drugs and devices.
Improving regulatory science via establishment of public-private partnerships between FDA, industry and academia, and through expansion of computer modeling and simulation to support device development and regulation.

Markets: USATags: 510(k), 510k, CDRH, Center for Devices and Radiological Health, FDA, medical device, Premarket Review

Author: Stewart EisenhartDate: January 26, 2012

FDA Orders Post-market Studies of Metal-On-Metal Hip Replacement Devices

The US Food and Drug Administration has ordered all manufacturers of “metal-on-metal” artificial hip devices to conduct post-market studies to see whether the implants are malfunctioning or causing health problems in patients.

According to a New York Times report, the FDA’s Center for Devices and Radiological Health (CDRH) issued letters May 6 to roughly 20 manufacturers notifying them of the order. Firms will have 30 days to develop their own post-market study proposals and submit them to the regulator; manufacturers will be required to collect data from patients using their devices as well as determine the frequency of device failures. Companies targeted by the order include Johnson & Johnson’s DePuy unit, Biomet, Stryker, Wright Medical and Zimmer.

In the Times article, Dr. William Maisel, deputy director for science at the CDRH, says the action constitutes the largest order of its kind for an approved class of devices. The agency’s move follows increasing reports over the last two years of metal-on-metal hip device failures as well as health problems such as soft tissue damage due to shedding of metallic debris.

Markets: USATags: Artificial Hip, Biomet, CDRH, Center for Devices and Radiological Health, DePuy, FDA, hip replacement, Johnson & Johnson, Metal-on-metal hip, Stryker, Wright Medical, Zimmer

Author: Stewart EisenhartDate: May 11, 2011

FDA Weighs Classifying EHRs as Medical Devices

The US Food and Drug Administration (FDA) is considering whether to regulate electronic health records (EHRs) as medical devices as it develops new rules targeting software, according to Center for Devices and Radiological Health (CDRH) director Dr. Jeffrey Shuren.

Healthcare Informatix reports that Shuren discussed the agency’s deliberations on EHRs April 7 at the PharmEHR Summit in Philadelphia. Given that the FDA has already begun regulating some software products as well as mobile medical applications, extending its reach to EHRs should at least be considered, argued the director.

If EHRs ultimately do fall under the CDRH’s purview, that could entail regulatory reviews of EHR providers’ manufacturing processes and design controls plus verification testing. As these products become more sophisticated and interface with more and more devices already under FDA regulation, Shuren said, EHR interoperability issues will have to be addressed and integration standards set regardless of whether the CDRH or some other regulator ends up overseeing them.

Markets: USACategories: Regulatory ComplianceTags: CDRH, Center for Devices and Radiological Health, EHR, EHRs, Electronic Health Record, FDA

Author: Stewart EisenhartDate: April 12, 2011

CDRH Updates Import Entry Review Process for Medical Devices

The US FDA’s Center for Devices and Radiological Health (CDRH) has issued recommendations to improve medical device import entry review processes to expedite entry of foreign-made products into the US.

In a March 24 Letter to Industry, CDRH director of compliance Steven Silverman noted agency concerns about the number of imported medical devices lacking adequate entry data necessary for timely admission into the US by the FDA.

“These recommendations will directly impact your company’s ability to import medical devices, electronic product components, parts and finished products into the US,” writes Silverman.

The agency is seeking to speed up admittance of submissions with correct Affirmation of Compliance (AofC) data—and persuade more medical device importers to ensure that their shipments adhere to AofC requirements to avoid the need for extended FDA entry reviews.

Failure to provide adequate AofC data, Silverman advises, often results in manual reviews of product entries, causing significant delays.

Accordingly, the FDA has published new and revised AofC codes for use in transmission of medical device import entries. All entries should include AofC codes for Device Foreign Manufacturer (DEV) or Device Foreign Exporter (DFE), Device Listing (DL), Device Initial Importer (DII) and Premarket Application (PMA), which can also be a Humanitarian Device Exemption (HDE), Product Development Protocol (PDP) number, Premarket Notification Number (PMN) or Investigational Device Exemption (IDE).

Although use of the afore-mentioned codes remains voluntary, the CDRH emphasizes that their use will result in more efficient and faster reviews of imported devices.

Silverman also notes that a separate letter addressing import entry filing processes for products subject to both medical device and electronic product radiation requirements is forthcoming from the agency.

The letter advises that questions regarding the FDA’s import entry review process be sent to the CDRH’s Office of Compliance Import/Export Safety Staff at cdrhocimport@fda.hhs.gov.