UPDATES

The medtech field is evolving rapidly as new ideas, products, and companies expand the realm of the possible and the healthcare system responds.  To help innovators stay current, this portion of the website will be dedicated to capturing important changes related to medtech regulation, reimbursement, IP protection, and other requirements (update icon).  It will also be used to address errata as they are discovered within the textbook (Errata Icon).

Update:

7/17/14 - 4.2 Regulatory Basics

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: 7/3/12 - 4.1 Intellectual Property Basics

USPTO to Open Four Satellite Offices
The United States Patent and Trademark Office (USPTO) announced plans to open new satellite offices in San Jose, Denver, Dallas, and Detroit. The new office locations are part the agency's efforts to expand and modernize under the Leahy-Smith America Invents Act of 2011. The move is intended to help the USPTO attract talent, reduce its backlog of unexamined patents, and speed up the overall process. The Detroit office is scheduled to open on July 13, 2012 (no other dates have been announced.) More information is available in a press release from the agency.

Errata10/18/11 - 6.1 Operating Plan and Financial Model

Figure 6.15 in the textbook is labeled as a bottom up market model, the caption should read "A sample top down market model."

Update: 10/4/11 - 4.2 Regulatory Basics

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:

9/28/11 - 4.1 Intellectual Property Basics

Prioritized Patent Examination Could Benefit Start-Ups

Under the new Leahy-Smith Act, individuals and companies may apply for a prioritized examination of their patent applications effective 9/26/11. 

The goal this process is to provide a final disposition within an average of twelve months from the time prioritized status is granted.  A maximum of 10,000 requests will be granted per fiscal year, with large entities paying $4,800 for prioritized examination and small entities paying $2,400. 

According to some observers, prioritized examination could be a benefit to small medical device companies, particularly as they seek funding.  The ability of start-ups to more rapidly protect their intellectual property is likely to be viewed positively by prospective investors.  For more information, please read the full article.

Update:

9/9/11 - 4.1 Intellectual Property Basics

Patent Reform Bill Signed Into Law

On September 16, President Obama signed the patent reform bill known as the Leahy-Smith America Invents Act into law, enacting the first major overhaul to the U.S. patent system in almost 60 years.

Three main changes are at the heart of the reform bill: (1) transitioning the U.S. from a “first to invent” to a “first to file” system for assigning patent rights; (2) giving the patent office a mechanism to tap into the revenue it generates to address the under-funding problem that has resulted in an enormous patent application backlog; and (3) creating a post-grant review process intended to reduce the number of time consuming, expensive patent disputes that go to court.

Importantly, many of the provisions in the new law related to patent litigation take effect immediately (and some are retroactive).  For an overview of the legislation, check out this Client Alert [pdf] from law firm Morrison & Foerster.

Update:

9/9/11 - 4.1 Intellectual Property Basics

Patent Reform Bill Poised to Become Law

On September 8, the Senate voted to adopt the House version of the patent reform bill known as the Leahy-Smith America Invents Act. President Obama is expected to sign the bill into law within the next 1-2 weeks.

Three main changes are at the heart of the reform bill: (1) transitioning the U.S. from a “first to invent” to a “first to file” system for assigning patent rights; (2) giving the patent office a mechanism to tap into the revenue it generates to address the under-funding problem that has resulted in an enormous patent application backlog; and (3) creating a post-grant review process intended to reduce the number of time consuming, expensive patent disputes that go to court. When it passes, the law will mark the first major overhaul to the U.S. patent system in almost 60 years.

Update:

7/1/11

Biodesign Innovation Textbook Now for Sale in Electronic Form
ebooks.com is now selling the textbook in electronic form.  Please see their website for further information on pricing and downloading.

Update:

4/5/11 - 4.1 Intellectual Property Basics

USPTO Begins Accepting “Track One” Patent Applications
In February 2011, the United States Patent and Trademark Office (USPTO) announced details regarding its new “Three Track” patent program.  For an additional $4,000 fee, Track One applications receive prioritized examination, including a first Office Action on patentability in four months and final disposition in 12 months of the filing date.  Track Two refers to regular examination.  Track Three allows requests for up to 30 months’ delay  before an application is added to the docket for examination.


According to Gary Locke, U.S. Commerce Secretary, “This new system will bring the most valuable patents, as determined by inventors, to market faster and will help shrink the backlog by catering to the business needs of America’s innovators.”  The USPTO will begin accepting Track One applications effective May 4, 2011.  To ensure it can meet the 12-month goal, the office intends to limit the number of Track One applications to 10,000 in the program’s first year. The USPTO intends to implement Track Three by the end of September 2011.

Update:

3/8/11 - 4.1 Intellectual Property Basics

Senate Passes Bill to Overhaul U.S. Patent System
In an effort to reduce the backlog of pending patent applications and improve the overall competitiveness of the U.S. patent system relative to other countries, the Senate passed a bill to reform key policies at the U.S. Patent and Trademark Office (USPTO).  Most notably, under the measure, the U.S. would transition from a “first to invent” to a “first to file” system for assigning patent rights.  This move, which is intended to reduce patent litigation costs, would bring the U.S. into alignment with most other major patent systems around the world.  However, as the Wall Street Journal points out, it could negatively affect innovators and small companies who lack the funds and expertise to rush their patent applications to USPTO. The bill will be considered by the House in the coming weeks.

Update: 2/15/11 - 4.2 Regulatory Basics and 5.4 Regulatory Strategy

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 - 4.2 Regulatory Basics

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 - 4.2 Regulatory Basics

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 - 4.2 Regulatory Basics

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: 10/19/10 - Instructor Resources

Needs from Biodesign Innovation Course now Available

Each year the Biodesign Innovation Fellows at Stanford spend several weeks in the hospital collecting needs.  These needs are then filtered using several criteria to a manageable number for use by the Biodesign Innovation class and the fellows themselves.  After this process several needs are still remaining which, when solved, could prove to have valuable solutions.  The Biodesign faculty are now providing these unused needs to the medtech academic community for use in their respective classes.  Please check under INSTRUCTOR RESOURCES [requires login] for the list of needs from the 2010 Biodesign Innovation class.

Update: 9/21/10 - 4.2 Regulatory Basics and 5.4 Regulatory Strategy

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 - 4.2 Regulatory Basics and 5.4 Regulatory Strategy

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: 4/26/10 - 4.2 Regulatory Basics

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.

Update: 4/21/10 – Conflicts of Interest

CMSS Announces New Code to Govern Interactions Between Specialty Societies and For-Profit Companies
The Council of Medical Specialty Societies (CMSS) released the “CMSS Code for Interactions with Companies,” which provides detailed guidance to medical specialty societies on appropriate interactions with for-profit companies in the health care sector (e.g., pharmaceutical and device manufacturers).  The Council developed this voluntary code to promote independence, transparency, and the highest ethical standards across its 32 professional society members. The code outlines seven core principles, which address topics such as conflicts of interest, financial disclosure, independent program development, and independent leadership.  Detailed guidance is also provided on implementation.  According to an article by AP medical writer Marilynn Marchione, one of the code’s most controversial rules is “requiring top leaders of any medical society and top editors of its journals to have no consulting deals or financial ties to industry.”  Read the full CMSS code to see a access a list of societies that have adopted it.  The Marchione article is also available.

Update:4/6/10 - Instructor Resources

Revised Winter Quarter Exam posted
We have revised the winter quarter exam that is available in the instructor resources part of the site.  The new exam features modifications based on feedback from students as to a few questions that were confusing.  You will need instructor privileges (registration with indication of course) and login to the site to download the new exam.

Update:3/4/10 - 4.2 Regulatory Basics

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.

Update:2/22/10 - 4.2 Regulatory Basics

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.

Update:2/9/10 - 4.2 Regulatory Basics

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.

Update:2/5/10 - 4.2 Regulatory Basics

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.

Update:1/20/10 – 4.2 Regulatory Basics

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.

Update:1/19/10 – 4.1 Intellectual Property Basics

Difference of Opinions Regarding Writing Your Own Provisional Patent Applications
In chapter 4.1 (page 220), we provide the following recommendations regarding the creation of a provisional patent application:

“Many medtech inventors choose to write their own provisional patents. This is a reasonable approach, provided that the application is thorough and sufficiently detailed to communicate the basic invention and support the claims of a later utility patent. However, it bears repeating that it is wise to have a patent attorney review the application prior to filing, if at all possible. There is no required format for the provisional application. The application should, however, include descriptions of (1) the need or problem that the invention addresses; (2) shortcomings of current solutions; (3) motivation for the new invention; (4) description of the invention (in enough detail that someone skilled in the field would know how to make it); and (5) advantages of this solution to the problem, including why it is strategically valuable.”

After reading this section, Vadim Gordin, a patent agent, law student, and biomedical engineering major, contacted us by email with the following concerns and suggestions:
“I submit to you the items 1, 2, 3, and 5 are not just superfluous to an application, but dangerous if included by an unsophisticated draftsman. Improper characterizations of the invention, its purpose, or the prior art by an inventor will, in almost all cases, foreclose breadth of patent rights later on in the future. When patent agents or attorneys include such language in applications, it is with very careful and specific wordings designed not to foreclose such rights. If you look to the USPTO provisional application guidelines, you will see that ALL that is required for the content of a provisional application is (1) a written description of the invention; and (2) drawings. Office actions (and not the application) are the proper place to convince the PTO of an invention’s novelty, non-obviousness, and utility (only when those questions arise). A patent application should include ONLY a detailed description of the invention, how it is made, and how it is used.”

In response to this feedback, we consulted with Jim Shay, a prominent patent attorney and partner with Shay Glenn LLP. Jim, who contributed to the development of this chapter, replied:
“Your student correspondent has a point, but I think the way we stated it in the book is completely correct. While there is some risk that by following our process the provisional will say unfortunate and limiting things, there also would be some risk that following his sparser approach the inventor would omit good information that would be helpful in pinning down an effective filing date for the invention. In the balance, I still recommend the approach we published.”

This dialog highlights the complex and exacting nature of preparing any patent application. Readers are advised to exercise appropriate caution in such matters and to seek the assistance of a qualified patent attorney before making a submission to the USPTO. Vadim added, “Most solo patent practitioners and some small firms will review applications that inventors have drafted for a fee that is a tiny fraction of the cost of drafting an application from scratch,” which can save innovators money while helping them avoid these common pitfalls. Our thanks go to both Vadim and Jim for sharing their thoughts.

update12/29/09 – 4.2 Regulatory Basics

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.

update12/12/09 – 4.2 Regulatory Basics

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.”

Errata12/9/09 - 5.4 Regulatory Strategy

Under step 1 in the Getting Started section for chapter 5.4, we mistakenly refer readers to section 510(g) of the Food, Drug and Cosmetic Act for more information about requesting device classification information from the FDA.  Requests for designations (or RFDs as they are known within the agency) are actually authorized under section 513(g) of the Act.  Guidance about when and how to submit an RFD can be found in CFR Title 21, Section 3.7. A useful document called “How to Write a Request for Designation (RFD)” is also available on the FDA website.

update11/4/09 – 5.7 Marketing and Stakeholder Strategy

New “Sunshine” Disclosure Law for Stakeholder Conflict of Interest
The healthcare reform bill under consideration in the U.S. House of Representatives and one of two health bills under review by the U.S. Senate would require pharmaceutical companies, medical devices manufacturers, and makers of medical supplies to produce annual reports for the government about their financial affiliations with physicians.  This legislation would also require companies to publish the information via a searchable, online public database.  While the “sunshine” provisions being considered by the Senate would be focused on the financial ties of payments made only to doctors and teaching hospitals, the provisions in the House would cover payments to all types of health care providers, including medical researchers, medical institutions, professional medical associations, industry-sponsored foundations, and disease advocacy groups.  According to an article in the New York Times, AdvaMed, a professional association in the medical device field, is supportive of the Senate version of a sunshine law.  More information can be found in the Times article.

update 11/2/09 – 4.2 Regulatory Basics

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 10/22/09 - 2.1 Disease State Fundamentals and 2.2 Treatment Options

Medical Librarians as a Valuable Resource for Disease and Treatment Research
When conducting disease and treatment research, another valuable source of information are the medical librarians who work in university, corporate, and medical center libraries, government agencies, and research centers and foundations.  Medical librarians are experts on finding and validating clinical information.  They can help save innovators significant time in identifying and summarizing disease state and treatment information, and also can help ensure that the most complete and up-to-date sources are used.  Many thanks to Alexander Feng, senior information specialist at Ethicon Endo-Surgery, Inc., a Johnson & Johnson company, who submitted this suggestion.  Feng is secretary of the Pharmaceutical & Health Technology Division of the Special Libraries Association.

Update Icon10/21/09 - 6.1 Operating Plan and Financial Model

Device Makers Face Downward Pricing Pressure
According to the Wall Street Journal, “While hospitals grapple with the economic downturn and the potential effects of health-care reform, they are pushing their financial troubles onto big medical-device companies” (see “Hospitals Ramp Up Pressure On Medical-Device Prices,”  Wall Street Journal, October 21, 2009.) In the article, executives at Johnson & Johnson, Boston Scientific, and St. Jude Medical all reported that they were facing increasing downward pricing pressure in their device businesses.  Innovators should watch this trend carefully and make appropriate adjustments when developing and/or maintaining their market models as part of a company financial plan.

Update Icon10/6/09 - 4.2 Regulatory Basics

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.

Update Icon8/15/09 - 4.1 Intellectual Property Basics

Number of Patents Awaiting Approval Triples in a Decade
According to an August 2009 posting by This e-mail address is being protected from spambots. You need JavaScript enabled to view it and This e-mail address is being protected from spambots. You need JavaScript enabled to view it of the Journal Sentinel Online, there are more than 1.2 million patent applications awaiting approval in the U.S.—nearly triple the number from a decade earlier. Moreover, patent analysis performed by the Journal Sentinel showed that the U.S Patent and Trademark office took an average of 3.5 years for each patent it issued in 2008—more than twice the agency's benchmark of 18 months.  The complete article can be found at the Journal Sentinal Website.

errata icon 8/26/09 - 1.2 Observation and Problem Identification

The photograph in Figure 1.2.4 should be attributed to Acclarent.  Our apologies for this error.

Update Icon8/14/09 - 4.2 Regulatory Basics

CDRH 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 Icon8/11/09 - 4.2 Regulatory Basics

Schultz Resigns, Shuren Appointed Acting Head of 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.


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