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 Draft Guidance Identifies Benefit-Risk Factors Used for Premarket Reviews

The US Food and Drug Administration has published draft guidance on the factors agency reviewers use to make benefit-risk decisions for premarket approval (PMA) medical device applications.

In making these factors public, the regulator hopes to improve predictability, consistency and transparency of its PMA process (as well as some 510(k) reviews).

First, the FDA considers measures for effectiveness of devices. Under this category, reviewers measure the type, magnitude and probability of benefits provided by a device, as well as the duration of those benefits for the patient.

Second, the agency considers measures for safety of devices. These include device-related serious and non-serious adverse events, procedure-related or indirect harms stemming from the device under consideration, and probability and duration of harmful events. Risks from false-positive or false-negative results produced by diagnostic devices also fall under this category of factors.

Additional factors the FDA lists in the guidance include uncertainty in terms of reviewers’ ability to determine reasonable assurances of safety and effectiveness; characterization of the disease or condition a device is designed to diagnose or treat; patient tolerance for risk, which can be affected by issues such as disease severity and chronicity; availability of alternative treatments; use of risk mitigations such as warning labelsto minimize the likelihood of harmful events; and novelty of technology used in a particular device.

The guidance also includes examples of how FDA reviewers use multiple combinations of factors to evaluate benefits and risks of particular medical devices. The FDA has also provided a draft of a Worksheet for Benefit-Risk Determinations in order to maintain more consistency in the PMA process, especially for devices requiring reviews across different agency divisions.

Markets: USACategories: Regulatory ComplianceTags: 510(k), FDA, medical device, PMA, Premarket Review

Author: Stewart EisenhartDate: August 15, 2011

FDA Publishes Changes to Premarket Review Standards

Effective March 8, the US FDA has issued modifications to the list of standards used by the agency in its premarket review process for medical devices.

The FDA’s move is intended to help device manufacturers that declare conformity with nationally and internationally developed consensus standards comply with associated requirements, according to the regulator’s Federal Register notice.

Changes to these standards will affect the following medical device product groups:

Anesthesia
Biocompatibility
Cardiovascular
Dental/ENT
General hospital/plastic surgery
IVD
Materials
OB-GYN/gastroenterology
Orthopedics
Physical medicine
Radiology
Software
Sterility

Updated consensus standards will be added to the FDA’s searchable database. Although the new changes have already gone into effect, the agency is accepting comments on an ongoing basis.

Medical device manufacturers whose products fall under any of the 13 categories listed above should familiarize themselves with how the FDA’s modifications may impact premarket reviews of their applications.

Markets: USACategories: Regulatory ComplianceTags: 510(k), consensus standards, FDA, Federal Register, Premarket Review

Author: Stewart EisenhartDate: March 16, 2011