One of the missions of the Medical Device Manufacturers Association is to ensure that patients have timely access to safe and effective medical technologies. Part of that means keeping an ever-watchful eye on the regulatory and legislative hurdles the industry must face.
In 2002, Congress passed the Medical Device User Fee and Modernization Act, or MDUFMA. The five- year user fee program imposed a series of fees upon manufacturers based on the types of device applications being submitted to the agency – premarket approval applications (PMAs) or 510(k)s, for example. The law also required additional funding from Congress.
MDMA was successful in advocating for a two tiered user fee structure in 2002 to provide greater fee relief for smaller companies. In 2005, MDMA successfully lobbied to increase the small business threshold to $100M in annual sales and also lobbied to cap annual fee increases to 8.5%.
What is MDMA Doing?
MDMA continues to work with FDA and the Hill to ensure that patients have timely access to safe and effective products. This includes addressing premarket and postmarket issues, fully implementing the interactive review process outlined under the FDA Amendment Act (FDAAA) of 2007 and working to improve coordination and interaction with the Agency. MDMA also continues to push for additional congressional appropriations so that FDA has the resources to meet the growing challenges of the agency and not rely on the industry for more user fees
2009
Senate Confirms Hamburg as FDA Commissioner
May 18, 2009 - The United States Senate confirmed Dr. Margaret Hamburg as the 21st Commissioner of the FDA. Hamburg replaces Acting Commissioner Josh Sharfstein, who will now take the role of Deputy Commissioner. Hamburg received widespread support in the Senate and was approved by voice vote.
The Medical Device Manufacturers Association looks forward to working with Commissioner Hamburg to ensure that patients have timely access to innovative medical technologies.
Panel Examines Device Preemption Bill
May 13, 2009 - A Capitol Hill hearing held yesterday examined the Medical Device Safety Act (MDSA) of 2009, a bill that would overturn a 2008 Supreme Court decision Riegel v. Medtronic, which bars common-law claims challenging the safety and effectiveness of PMA approved medical devices. The Medical Device Manufacturers Association has concerns that the MDSA would significantly stifle innovation in the industry and limit patient access to medical technologies. Wall Street Journal Article
Senate Panel Confirms Hamburg Nomination
May 8, 2009 - The Senate Health, Education, Labor and Pensions (HELP) Committee reviewed the nomination of Dr. Margaret Hamburg to be Commissioner of the Food and Drug Administration (FDA). Hamburg was asked a broad range of questions by Committee Members ranging from the Agency’s ability to handle food recalls to the regulation of tobacco. Hamburg was also asked about her role at the Agency, citing speculation the current Deputy Commissioner, Josh Sharfstein, would be responsible for drug and device regulation while Dr. Hamburg would oversee food regulation. Hamburg stated that the speculation was inaccurate and there would be shared responsibility across the agency.
The Committee voted to confirm Dr. Hamburg. It is speculated that she will be confirmed before the full Senate prior to the Memorial Day recess.
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Administration Releases FY 2010 Budget Proposal
May 7, 2009 - President Obama released the Administration’s Fiscal Year 2010 budget proposal this week. The budget request for the Food and Drug Administration totals $2.35 billion, nearly $300 million more than in FY 2009. This figure, however, does not account for the additional revenue generated by user fees of the industries the Agency regulates. Including all user fees, President Obama’s total budget request for FDA is $3.2 billion.
MDMA is reviewing the budget in greater detail and will provide members an analysis during the next FDA Working Group meeting.
Read more
FDA Will Review 25 Pre-amendment Class III Product Categories
April 9, 2009 - FDA published an Order in the Federal Register requiring manufacturers of twenty-five (25) Class III pre-amendment devices to submit to FDA a summary of, and citation to, any known, or otherwise available, safety or efficacy information, including that information which has not been submitted under section 519 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360i). See (74 FR 16214). The twenty-five (25) devices identified are those Class III pre-amendment devices for which a final regulation requiring the submission of a PMA has yet to be issued. See section 501(f)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 351).
The action follows a January 2009 report by the Government Accountability Office recommending that the Agency work quickly to reclassify these products.
Required Submission of Safety and Effectiveness Information
New FDA Commissioner and Principal Deputy Announced
March 19, 2009 - President Obama announced the nomination of Dr. Margaret Hamburg to be the Commissioner of the Food and Drug Administration. Dr. Hamburg has held a number of positions within the Federal government including serving as Assistant Director of the National Institute of Allergy and Infectious Diseases of the National Institutes of Health as well as serving as the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services. Dr. Hamburg will undergo the Senate confirmation process before the Health, Education, Labor and Pensions Committee.
In addition, President Obama also announced the appointment of Dr. Joshua Sharfstein as Principal Deputy Commissioner for the FDA. Dr. Sharfstein is currently the Commissioner of Health for the City of Baltimore. In addition, Dr. Sharfstein spent time on Capitol Hill as a staff member of Congress Henry Waxman. He will not have to undergo Senate Confirmation.
It is widely speculated that Dr. Hamburg will primarily oversee food responsibilities of the agency and Dr. Sharfstein will oversee the drug, device and cosmetic offices. Dr. Sharfstein is currently Acting Commissioner for the Agency while Hamburg awaits Senate confirmation.
Lawmakers Propose FDA Inspections Bill
January 31, 2009 - This week lawmakers proposed legislation this week which would overhaul the FDA inspection process for food, drug, device and cosmetic manufacturing facilities abroad. The bill, the Food and Drug Administration Globalization Act (FDAGA), would require device manufacturers to pay a new annual fee to fund inspections. The legislation is silent on the actual amount of the fees. The bill does include improvements from last year’s bill.
MDMA has met with Hill staff expressing concerns with industry funding the inspection process, especially in light of recent increases in the fees associated with the FDA review process. Further, MDMA stressed that any funding for such obligations should stem from Congressional appropriations, and not the industry. Read More
GAO Releases Report Validating Current 510(k) Review Process
January 15, 2009 -The Government Accountability Office (GAO) published a report on FDA’s 510(k) review process. The report validates the current 510(k) review process. However, the GAO recommended that FDA review the small number of Class III products currently using the 510(k) premarket review pathway and either reclassify the products or require them to be reviewed via the PMA process. MDMA agrees that this is the appropriate approach versus modifying the underlying 510(k) process. To read the report click here 
2008
FDA to Open First Overseas Inspections Office in China
November 18, 2009 - The Food and Drug Administration (FDA) opened its first international office in China in November. The opening of the office comes in light of increased scrutiny of the overseas inspection process conducted by the FDA. The China office is the first of several planned international offices to station permanent food, drug and device inspectors.
More information
FDA Releases Final Rule Clarifying Device Labeling Changes
October 1, 2008 - The Food and Drug Administration recently released a final rule regarding the parameters in which a device manufacturer can modify label changes to a product. Specifically, manufacturers can add or strengthen the contraindications, warnings, precautions or adverse reactions sections of labeling via a PMA supplement without prior FDA approval only when such modifications are based on newly acquired information and evidence of a causal association between the product and a safety signal is present. The rule also provides clarification as to what the Agency considers to be new information to be incorporated into a label change. Specifically, new information “must reveal risks of a different type or greater severity or frequency than previously included in submissions” and includes meta-analyses, the new regulation states.”
Congress Approves Additional Funding for FDA
June 10, 2008 - Congress passed a continuing resolution this quarter intended to temporarily fund government operations until official appropriations are agreed upon. Included in this appropriation was additional funding for operations at the FDA. Specifically, the Agency will receive an additional $150 million in Fiscal Year 2009. The FDA will, in total, receive approximately $300 million more over 2008 appropriation levels. As a member of the Alliance for a Stronger FDA, MDMA has worked with other stakeholders to lobby the Hill for additional funds.
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FDA Surveillance Will Not Burden Industry, According to Agency Official
May 30, 2008 - Thomas Gross, the Director of the FDA Centers for Device and Radiological Health, Division of Postmarket Surveillance announced that the new FDA postmarket surveillance system, the Sentinel Initiative will not place additional regulatory burdens upon the device industry. The Sentinel Initiative stems from the Food and Drug Administration Amendments Act of 2007 and would allow for greater collaboration between the FDA and CMS to monitor post-market adverse events. The initiative would focus on creating a database to track adverse events in real time by utilizing claims data from the Medicare prescription drug program for public health and safety research, quality initiatives, care coordination and other research and analysis. Gross cited that regulations for device approvals already in place will effectively monitor postmarket events.
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MDMA Testifies on FDA Globalization Act
May 14, 2008 -
Kelvyn Cullimore, President & CEO of Dynatronics Corp. and MDMA Board Member, testified this week on the FDA Globalization Act. The hearing, held by the House Energy and Commerce, Subcommittee on Health, highlights the Committee’s efforts to move forward the legislation which would create additional user fees for manufactures and increase the number of pre-approval inspections in foreign and domestic facilities. Cullimore, on behalf of MDMA, expressed several concerns with the bill. Specifically, he cited that the legislation, as currently drafted, would compel manufacturers to pay additional and overly-burdensome user fees, despite the fact that the industry just recently agreed to double the amount of fees paid under the Food and Drug Administration Amendments Act of 2007. In addition, Cullimore argued that the legislation would also cause delays in access to innovative and life-saving medical technologies by requiring pre-approval inspections for products regardless of the level of risk posed.
MDMA's Complete Testimony 
MDMA Submits Comments on FDA Reprint Guidance
April 21, 2008 -Today MDMA submitted comments to the FDA related to the distribution of medical or scientific journal articles and reference publications that involve off-label use of medical devices. Previously, Section 401 of the Food and Drug Administration Modernization Act set out guidelines that allowed the dissemination of information on unapproved uses of FDA-approved products. As long as the guidelines were met by the manufacturers, the dissemination of this type of information was not viewed by the FDA as evidence of an intent to promote the product for an unapproved or off-label use. However, Section 401 expired on Sept. 30, 2006.
MDMA's comments
Supreme Court Limits Lawsuits Against Medical Device Manufacturers
February 22, 2008 - In a landmark decision, the Supreme Court upheld initial lower court rulings that medical device manufacturers cannot be held liable in state tort cases if the device has been approved by the Food and Drug Administration. The case, Reigel v. Medtronic, is significant because it reaffirms that existing Federal device approval laws preempt individual state regulations. Specifically, the ruling applies to devices approved by the FDA under a premarket approval (PMA) application.
MDMA submitted an amicus curiae brief before the Court argued the case.
The text of the case 
Congress Asks GAO to Review FDA Resources Shortfalls
February 1, 2008 - Congressman Henry Waxman (D-CA), Chairman of the House Oversight and Government Reform Committee, and Senator Edward Kennedy (D-MA), Chairman of the Senate HELP Committee, recently asked the GAO to conduct a thorough review of the level of FDA resources. Specifically, the lawmakers are requesting an examination to determine if there are adequate levels of staffing, information technology, and other resources in order for the FDA to perform its regulatory function.
The request comes in light of a recent FDA Science Board study which reported that the FDA is not receiving necessary resources in spite of a growing demand on the Agency.
Click here to read the letter
The FDA Science Board report
FDA Releases Guidance for Interactive Review
January 4, 2008 - As set forth by the Food and Drug Administration Amendments Act of 2007 (FDAAA), FDA recently published its interactive review guidance document for both industry and FDA Staff. The interactive review process is aimed at enhancing the review of 510(k), PMA and BLA submissions to establish a framework for a more aggressive set of performance goals by enhancing and facilitating communication between FDA staff and industry during the review of submissions.
Click here for guidance from FDA’s website
FDA Certification for Clinical Trials Reminder
2007
New Certification to Accompany Device Applications/Submissions
December 14, 2007 - As a result of the Food and Drug Administration Amendments Act of 2007, a new certification is now required to be submitted to the clinical trials data bank (ClinicalTrials.gov), including expanded information on clinical trials and information on the results of clinical trials. Applicants must certify at the time of an application or premarket notification submissions that they have complied with this new requirement. Applications must be submitted to the agency beginning on December 26, 2007 and the new requirement applies to all applications made on or after the 26th.
Click here for more guidance
Final Certification Form
President Signs the Food and Drug Administration Amendments Into Law
September 27, 2007--
The President signed the Food and Drug Administration Amendments of 2007 into law earlier this week, only a few days before the current law was set to expire. Congress overwhelmingly passed the measure which will reauthorize the user-fee program for pharmaceutical and device manufacturers as well as provide new regulatory authority to the FDA. With passage of the legislation, the FDA will collect approximately $287 million from device manufacturers over a five-year period to finance both pre- and post-safety market reviews. In addition, the law creates a public, searchable database of clinical trials for drugs and medical devices. The database will include information on safety risks and will be administered by the National Institutes of Health.
Specific device provisions from MDMA's FDA counsel Latham and Watkins
House Passes FDA Amendments of 2007
July 10, 2007 -- The House passed the HR 2900, The Food and Drug Administration Amendments of 2007, by a vote of 403-16. The bill includes provisions which would reauthorize the device user fee program, establish a device registry and results database, and enhance the 3rd party inspection program. As you know, MDMA worked with FDA and other stakeholders to make significant improvements from the earlier House versions of the bill. Given that differences still exist between the Senate and House bills, a conference will be required before final passage. However, final passage is expected before the August recess which begins on August 3rd.
House Energy & Commerce Health Subcommittee Drops 9 FDA bills
June 7, 2007 -- Chairman Pallone (D-NJ) of the House Energy and Commerce Health Subcommittee dropped 9 FDA bills including the reauthorization of the medical device user fee act and he has scheduled a June 14th markup of the legislation. The 9 bills have some significant differences from the Senate’s FDA Revitalization Act of 2007 and MDMA is in the process of reviewing the legislation and developing an appropriate response.
To read the House legislation pertaining to medical devices, please click here.
MDMA Testifies Before Congress on MDUFMA II
May 16, 2007-- Today, MDMA Board Member, Kelvyn Cullimore Jr. testified before the House Energy and Commerce Subcommittee on Health to discuss the reauthorization of the Medical Device User Fee and Modernization Act (MDUFMA). MDMA expressed support of the agreement reached by FDA, MDMA, and other stakeholders. The association also emphasized the need for increased congressional appropriations in the future to ensure that the user fees do not become the primary source of funding for FDA.
To read MDMA's testimony click here.
Senate HELP Committtee Approves MDUFMA Reauthorization
April 18, 2007 -- The Senate Health, Education, Labor and Pensions Committee (HELP) voted 15-5 in favor of the FDA Revitalization Act of 2007 which included provisions to reauthorize MDUFMA. MDMA has been in discussions with FDA and other industry stakeholders to reauthorize the program which will help ensure that patients have timely access to safe and effective products. Specifically, MDMA sought to improve and simplify the MDUFMA performance goals, increase collaboration between FDA and the industry, and create a fee structure that is more stable and provides greater fee relief for small companies. Fortunately, the agreement reached by FDA and industry and approved by the Senate HELP Committee yesterday achieves these objectives.
To learn more about the agreement please click here.
FDA Releases Long Awaited Draft Guidance on PMA Approval
March 16, 2007-- Last Friday, the Food and Drug Administration (FDA) released the long awaited draft guidance for industry and FDA staff on Modifications to Devices Subject to Premarket Approval (PMA) – the PMA Supplement Decision Making Process. The draft guidance document reflects FDA’s review of what they believe are the relevant issues related to providing regulatory submissions for modifications to medical devices (including in vitro diagnostics regulated by CDRH or CBER) and what FDA believes would be the least burdensome approach. Comments are due in 90 days.
To read the guidance, please click here.
Senator Hatch Sends Letter to the FDA Regarding MDUFMA II Negotiations
March 22, 2007-- Today, Senator Orrin Hatch (R-UT) sent a letter to the FDA regarding the appropriations “trigger.” In the letter, Hatch stated that the appropriations committee has always set a Center for Devices and Radiological Health specific appropriations trigger for the collection of industry user fees and that he believed Congress should continue with the current policy rather than a Food and Drug Administration – wide appropriations trigger. To read Senator Hatch’s letter, please click here.
President Releases Fiscal Year (FY) 2008 Budget
February 5, 2007- The President released his $2.9 trillion budget proposal for Fiscal Year (FY) 2008. In the budget, the President requested for the Food and Drug Administration (FDA) a budget total of $2.1 billion, which is a net program level increase of $263 million over the Fiscal Year (FY) 2007 Continuing Resolution. Within the overall FDA budget, the President requested a total of $240 million for the Center for Devices and Radiological Health (CDRH), which is a total of $20 million over the FY 2007 Continuing Resolution. MDMA is working with FDA to determine the impact that the budget will have on the MDUFMA II negotiations.
Archived FDA/MDUFMA Updates
REUSE
The U.S. Food and Drug Administration (“FDA”)
has a rigorous premarket review and approval or clearance
process for Single-Use Medical Devices (“SUDs”).
This premarket review establishes the safety and effectiveness
of the new SUD for use in a single patient, following which
the device is intended to be permanently discarded. Notwithstanding
the clearance or approval of SUDs for a single-use only, many
such devices are collected, cleaned and sterilized following
their use. These reprocessed devices are then recycled and
reused frequently several times before they ultimately are
discarded.
Prior to the enactment of the Medical Device User Fee and
Modernization Act (“MDUFMA”), the FDA did not
rigorously scrutinize reprocessed SUDs to ensure that they
remained safe and effective after reprocessing and reuse.
This raised public, professional, industry, and Congressional
concerns regarding the lack of demonstrated safety and efficacy
of reprocessed SUDs on reuse. A number of articles highlighting
the risks associated with reprocessed SUDs appeared in several
high profile magazines and newspapers, including: Neil Weinberg,
Blood Money: Junkies reuse discarded medical equipment—and
it turns out maybe you do, too, courtesy of cost-cutting hospitals,
FORBES (March 22, 1999); Dana Hakins, Risky Recycling:
That "disposable" catheter may have been used before,
U.S. NEWS & WORLD REPORT (Sep. 20, 1999); Gina Kolata,
‘Single Use’ Medical Devices are Often Used
Several Times, NEW YORK TIMES (Nov. 10, 1999).
In February, and again in August, 2000, FDA issued guidance
documents clarifying its reprocessing regulations. After the
House Energy and Commerce Committee, and Senate Health, Education,
Labor, and Pensions Committee, conducted two formal oversight
hearings in 2000, Congress concluded that the FDA’s
efforts, and existing regulatory framework was not adequately
protecting patients from the risks associated with the reprocessing
and reuse of SUDs, and that it needed to enact legislation
to establish stronger regulatory controls over the reprocessing
industry. In 2002, Congress enacted MDUFMA which imposed new
safeguards for reprocessed devices, requiring FDA to apply
premarket controls to assure that reprocessed SUDs are held
to the same standards of safety and efficacy as all other
devices and imposed reporting and labeling requirements to
better identify and track adverse events associated with SUDs.
2006
The House holds a Hearing on SUDs
On Tuesday, September 26, the House Government Reform Committee held a hearing on reprocessed single use devices (SUDs). As you know, MDMA has worked with our member companies, FDA and Congress to create better oversight for these products.
CDRH Issues Draft Guidance for Labeling of Reprocessed Devices
May 5, 2006- The FDA’s Center for Devices and Radiological Health (CDRH) issued draft guidance for FDA and industry for compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002. Section 301 has to do with the proper labeling of reprocessed devices, and was amended by the Medical Device User Fee Stabilization Act of 2005, which was passed in August of 2005. MDMA strongly believes that unmarked reprocessed single-use devices may a pose significant patient safety risk. According to the language in the guidance, the amended requirement, “will give health care providers necessary information so they can report device related adverse events accurately and promptly to FDA.”
To learn more, click here.