4.2 Regulatory Basics - Updates

Update: 7/16/14

FDA distributes National Medical Device Curriculum
A new learning tool for academic institutions and science and technology innovators to advance their knowledge of FDA medical device regulatory science processes.  The curriculum provides students with core knowledge on necessary expertise to design, test and clinically evaluate devices, identify the root causes of adverse events and device malfunctions, develop iterative device designs, and navigate the regulatory process.  The curriculum comprises a series of four fictional case studies based on real-world medical device scenarios in a format similar to Harvard Business School Case Studies.

Update: 10/4/11

FDA Piloting Plan to Involve Outside Experts in Device Review Process
The FDA's Center for Device and Radiological Health (CDRH) has initiated a 12-week pilot program designed to test the idea of using outside scientific experts to provide specialized knowledge about emerging medical device technologies.  The goal of the program is to help speed up regulatory reviews and make the process more predictable and transparent.  According to the proposal, the role of the new "Network of Experts" is to provide information and input to FDA regulators, not to make policy recommendations.  The pilot program will run through December 30, 2011. The agency is also soliciting public comments through October 28, 2011.  Visit the FDA website for more information.

Update: 2/15/11

New Regulatory Videos Available on eBiodesign
The Stanford University Biodesign team has developed a series of video briefs that address important information about medtech regulatory processes and requirements in the U.S. The videos, which were funded by the Kauffman Foundation, feature regulatory experts Su-Mien Chong and Howard Holstein.  They are intended to reinforce and expand upon the regulatory content covered in the Biodesign text. The videos present content on regulatory basics, fundamental regulatory strategies, and several short case studies on medtech companies and their interactions with the FDA.

Update: 2/8/11

CDRH Announces New Medical Device Innovation Program
In an effort to speed the review of breakthrough medical devices, the FDA’s Center for Devices and Radiological Health proposed a priority review program for breakthrough medical devices. Through the initiative, CDRH hopes to reduce premarket review time for qualified products to 150 days. The new Innovation Pathway will be piloted using a brain-controlled, upper-extremity prosthetic developed by the Defense Advanced Research Projects Agency (DARPA).

According to Jeff Shuren, director of CDRH, the center will select a small number of applications each year for the innovation pathway through a new Center Science Council made up of senior managers and experienced staff. A case manager will work with the company to develop a roadmap and timeline for device development, assessment, and regulatory review. The company and case manager will also collaborate on defining clinical trial protocols through an interactive process that allows for repeat testing and redesign, as needed. “By front-loading our resources, we can reduce unnecessary delays and review these devices for approval in roughly half the time it takes for the typical premarket approval, or PMA, application,” said Shuren. To be eligible, a device must demonstrate the potential to revolutionize disease treatment, diagnosis, or health care delivery and/or target unmet medical needs. Shuren also emphasized that any device that utilizes the Innovation Pathway must still adhere to defined regulatory standards for new applications.

CDRH has set up a public docket to solicit public comment on the Innovation Initiative and will host a public meeting on the topic on March 15, 2011 at the Center’s White Oak campus. More information is available on the FDA website.

Update: 1/20/11

FDA Announces Changes to 510(k) Process
The FDA announced 25 changes it plans to make to the 510(k) process this year, including streamlining the review process for some low-risk devices, clarifying when clinical data is required to support 510(k) submissions, and establishing a council of agency experts to work on making reviews more timely.  However, the agency delayed the implementation of some of its other proposed changes, at least until the Institute of Medicine releases its guidance this summer.   After the FDA's 510(k) recommendations were released in August 2010, industry representatives provided extensive feedback to the agency indicating they could be detrimental to U.S.-based medical device innovation.  The decision to postpone the implementation of additional changes was generally viewed positively by medtech associations and companies.

Update: 12/27/10

New Medical Device Standards Announced in China
China’s State Food & Drug Administration (SFDA) released 96 new industry standards related to medical device regulation in China. Approximately one-third of the new standards are mandatory (labeled YY); the others are recommended (labeled YY/T).  SFDA will begin enforcing the mandatory standards effective June 1, 2012.  A listing of the new industry standards is available on the SFDA website (although only in Chinese at present).

Update: 9/21/10

Two new FDA web resources now available
As part of its efforts to improve transparency at the FDA, the agency launched two new web-based resources. The first is a site called FDA Basics (www.fda.gov/fdabasics), which seeks to provide information about how the agency performs its works.  The second is a program performance tracking site called FDA-TRACK (www.fda.gov/fdatrack) where the agency posts metrics regarding the workload and results of more than 100 FDA offices.  More information about the sites and the FDA’s transparency initiative can be found in a New England Journal of Medicine article  by Afia K. Asamoah and Joshua M. Sharfstein (see http://www.nejm.org/doi/pdf/10.1056/NEJMp1005202).

Update: 8/4/10

CDRH Releases Preliminary Recommendations Regarding Changes to Medical Device Regulation
On August 4, 2010, the Center for Devices and Radiological Health (CDRH) released a series of recommendations developed to support three key objectives: “fostering medical device innovation, enhancing regulatory predictability, and improving patient safety.”  The recommendations stem from two inter-related reports issued by the 510(k) Working Group and the Task Force on Utilization of Science in Regulatory Decision Making, which were established in September 2009.  The full reports from these working groups can be found online.

In a foreword (pdf) to the reports, CDRH Director Jeffrey Shuren highlighted 10 specific recommendations.  Among the most important were the following:

  • Streamlining and clarifying the de novo review process for lower-risk devices that are automatically classified at Class III because no suitable predicates exist.
  • Defining guidelines for a subset of moderate-risk Class II devices, called Class IIb, for which clinical or manufacturing data typically would be required to support a substantial equivalence determination.
  • Revising regulations to explicitly require all 510(k) applicants to provide a summary of all scientific information known (or that should be reasonably known) regarding the safety and effectiveness of a new device.

FDA is now collecting public input on the recommendations, which can be submitted online ( through October 4, 2010 -- reference Docket No. FDA-2010-N-0348).

Shuren also announced that the CDRH has established a Council on Medical Device Innovation, which is chartered with identifying unmet public health needs and facilitating the design (or redesign) of devices to address them.  Furthermore, he said, the FDA signed a memo of understanding with the Centers for Medicare and Medicaid Services (CMS) to share information and coordinate efforts to streamline the process of bringing safe and effective new medical technologies to patients.

Update: 6/8/10

Tillman Steps Down from ODE Leadership
Donna Bea Tillman has announced her resignation as head of the Office of Device Evaluation in order to take a position as Microsoft's director of regulations and policy for in their health information unit.

Update: 4/26/10

FDA Modifies Advisory Panel Rules for Devices on PMA Pathway
Effective May 1, 2010, the U.S. Food and Drug Administration is changing the rules that govern the expert panels that review medical devices under consideration for premarket approval from the agency.  The new guidelines were prompted by the growing number of panels being conducted each year and are designed to facilitate more focused panel discussions and improved decision making.  Under the new rules, panel members will vote on the safety, effectiveness, and risk versus benefit of a device (rather than on its approvability). According to CDRH Director Jeffrey Shuren, "By making this change in voting procedure, panel members will address key scientific issues during their discussions, which will be reflected in their votes.  The change also will allow panel members to address issues related to their area of expertise instead of regulatory issues that may be unfamiliar to them."  Additionally, votes will now be collected via individual ballots (that are publicly tallied) instead of by a show of hands to prevent panel members from being influenced by the way others are voting.  More information the about new rules is available.


New Regulatory Process Flows Available for 10 Major Device Markets
Emergo Group,  a medical and IVD device consulting firm focused on regulatory affairs, quality system compliance, and clinical trial consulting, has developed a set of charts that summarize the regulatory processes of 10 major medical device markets around the world.  The process flow diagrams include Australia, Brazil, Canada, China, Europe, Japan, Korea, Mexico, Russia, and the United States.


MHRA Answers Common Questions About Device Registration in the UK
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has added a new “frequently asked questions” section to its website to address common questions about the registration of medical devices. Useful information about forms, fees, and documentation is available.


John Dalli Confirmed as the EU’s New Commissioner for Health and Consumer Policy
With the European Parliament’s approval of the new European Commission, John Dalli became Commissioner for Health and Consumer Policy. In this role, he will oversee the regulation of the medtech and pharmaceutical industries in the EU through October 2014.  More information is available.


FDA Releases Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials
The FDA has introduced new guidance regarding the use of Bayesian statistical methods in the design and analysis of medical device clinical trials. According to the agency, this approach may make it possible for companies to combine data collected in previous studies with the data from a more current trial to justify a smaller-sized or shorter-duration pivotal trial. Read the complete FDA guidance document.


Shuren becomes CDRH's Director
Margaret Hamburg, commissioner of the FDA, announced that Dr. Jeffrey Shuren would become the permanent director of the agency’s Center for Devices and Radiological Health (CDRH). Shuren had been serving as the center’s acting director since September 2009, following the resignation of Daniel Schultz. According to an SNM SmartBrief story, he is expected to oversee changes at the CDRH, including efforts to make product reviews more rigorous and ensure more transparent decision-making processes. See Advamed's SmartBrief.


More Device Regulation Changes May Be Looming at the FDA
According to a recent article (Alicia Mundy and Jared A. Favole, “Doctors’ Spat Exposes FDA Loophole,” Wall Street Journal, December 29, 2009), the FDA may issue revised guidance requiring device manufactures to notify the agency of any modifications made to approved products before they are used in humans. This potential change stems from a dispute at Northwestern University involving a heart device called a Myxo mitral-valve ring. A well-known heart surgeon, Dr. Patrick McCarthy, modified a valve that was already on the market and implanted the new variation in more than 150 patients. The company manufacturing device, Edwards Lifesciences Corporation, did not seek FDA permission before the modified device was used in patients under a current FDA guidance document issued in 1997. This document permits the sale of certain new devices without the need for regulatory approval if the device is a version of an FDA-approved product from the same company. However, Dr. McCarthy has been accused of using an experimental device without patient consent. As a result of the controversy surrounding the dispute at Northwestern, the FDA has acknowledged that the existing guidance document is “not entirely clear.” A review of the guidelines is currently underway. Brad Zuckerman, director of the FDA’s Division of Cardiovascular Devices, indicated that companies may be required to contact the agency in advance if they plan to change approved devices.

update 12/12/09

Internal and External CDRH Reviews Underway
In response to recent controversy over the 510(k) clearance process of the FDA’s Center for Devices and Radiological Health (CDRH), the Institute of Medicine is convening a panel to review the 510(k) pathway and make a recommendation (due in 2011). The agency also has initiated an internal review by setting up a "working group" to evaluate its processes.  As part of this review, the FDA will be seeking public and industry input.  According to at least one editorial, “The challenge for the FDA is to strengthen its process without stifling new products and putting an undue regulatory burden on device companies, which are struggling to find venture capital in today's economy and potentially face a hefty new tax to fund health reform.”

update 11/2/09

China to Streamline Regulation for Medical Devices
According to Ralph Ives, executive vice president of global strategy and analysis for AdvaMed, the Chinese government recently announced measures that will “save medical device manufacturers hundreds of millions of dollars of potential costs related to doing business in China.”  Among other changes, China’s State Food and Drug Administration (SFDA) indicated that it will not automatically require clinical trials conducted in China for certain classes of devices, but will instead adopt a risk-based approach and consider the results of studies conducted outside the country. It also implemented an exemption from testing product samples in Chinese test labs prior to regulatory approval, as long as device manufacturers had strong scientific evidence and could demonstrate compliance with international standards.  Additionally, the SFDA indicated that it would seek to adopt other requirements and rules that are aligned with guidance by the Global Harmonization Task Force and the Asia Harmonization Working Party.  More information can be found at the DeviceLink website.

Update: 9/14/09

FDA Moves to Silver  Spring, MD
The FDA's Center for Devices and Radiological Health (CDRH), the division that oversees most device-related regulatory submissions, moved to the agency's new headquarters in Rockville, Maryland.  The new address is 10903 New Hampshire Ave., Silver Spring, MD 20993.

Update: 9/11/09

Schultz Resigns, Shuren Appointed Acting Head for CDRH
Daniel Schultz, head of the FDA’s Center for Devices and Radiological Health (CDRH) resigned per an agreement with FDA Commissioner Margaret Hamburg (who was appointed by President Obama in May).  Schultz had served as director of the CDRH for the last five years. Jeff Shuren, the agency’s current associate commissioner for policy and planning, was appointed to lead the CDRH on an acting basis.

Update: 10/6/09

FDA to Expedite Public Notification of Regulatory Decisions
The Food and Drug Administration (FDA) announced that it will expedite public notification of medical device-related regulatory decisions and make the information more accessible by posting it to the agency’s website.  Previously, this information was published through the Federal Register.  The new listings will include monthly listings of premarket notification [510(k)] and premarket approval (PMA) decisions, information on humanitarian device exemption (HDE) approvals, searchable databases of devices previously approved for marketing or declared substantially equivalent to a legally marketed device, and frequently asked questions about recently approved devices.

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