Devices and Radiological Health

1/ Includes Salaries & Expenses, Rent and PDUFA, where applicable.

2/ Includes MQSA user fees. FY 2001 includes proposed Device Premarket user fees of $5.8 million and 30 FTE.

EXPLANATION OF PROGRAM

FDA promotes and protects the public health under the Medical Devices and Radiological Health program by ensuring the safety and effectiveness of medical devices; eliminating unnecessary exposure to radiation from medical, industrial, and consumer products; and maximizing the benefits from necessary exposure. To accomplish these goals, FDA conducts a variety of activities. The following are the most significant:

• Classifies medical devices into the appropriate regulatory category (Class I - general controls; Class II - special controls; and Class III - premarket approval).
• Reviews Premarket Approval Applications (PMAs) to ensure the data submitted by the manufacturer demonstrate the device is safe and effective; reviews Premarket Notifications [510(k)s] to ensure the data submitted by the manufacturer demonstrate the device is substantially equivalent to an eligible product already on the market; and reviews Investigational Device Exemption applications (IDEs) to ensure that proposed investigational studies will be well-controlled and will safeguard the rights and safety of human subjects.
• Conducts postmarket surveillance to ensure the continued safety and effectiveness of marketed devices and radiation emitting products, once they have been approved.
• Promulgates and enforces quality standards under the Mammography Quality Standards Act of 1992.

FY 2001 BUDGET REQUEST

ASSURING SAFETY/STRENGTHENING SCIENCE INITIATIVES

PREMARKET INITIATIVES + $7.7 MILLION, 14 FTE

Bringing Products of New Technology to Market + $7.7 million, 14 FTE

Limited scientific knowledge delays health and safety benefits and may lead to over-regulation because of inadequate understanding of the risks involved. Requested resources will be used to improve the premarket process through:

• Increase product review efforts to ensure patient access to innovative technology such as genetic testing and ensure the safety and efficacy of products such as reprocessed devices. Shortened review times and earlier marketing of these types of devices provide significant benefits to patients and to industry. To improve the premarket program, FDA will:

• Develop new regulatory approaches to deal with the scientific breakthroughs resulting from genetic testing. The number of genetic tests performed is growing dramatically by a much as 30 percent each year. FDA will explore a wide range of genetic testing issues including the safety and effectiveness of genetic tests and the oversight of laboratories developing genetic tests.

• Increase product review activities and develop standards for high-risk reuse applications to ensure that if a single-use device is going to be reused, it is done safely and remains safe and effective for its intended use. While reprocessing has occurred for some time, there is little data available on the safety or effectiveness of certain types of reprocessed devices and the single-use labels are not clearly meaningful and do not identify vulnerabilities for reused devices that are intended to be used only once.

• Continue to strive to meet statutory PMA review times and increase scientific interactions with industry during review, an important goal for the Agency. With technological developments such as genetic testing, reprocessed devices, and combinations with drugs and biologics, the device workload and scientific complexity are increasing rapidly. Where necessary, FDA will seek outside expertise to ensure that its regulatory decisions are based on the latest scientific knowledge, and are performed in an expedient manner. During the past two years, more than 800 new technological products have come on the market or are under development. One example of new technology is the approval of the Home Access® Hepatitis C Check and Hepatitis C Check Express test kit. The kits are for home use for collection of a dried blood spot specimen by finger-stick and indicated for the anonymous testing for antibody to Hepatitis C virus (HCV) in adults who may have been exposed to HCV. Nearly 4 million Americans are infected with HCV and approximately 30,000 new acute infections are estimated to occur each year. (Devices Performance Goals #1, 2)

• Improve the scientific information base and develop efficient evaluation methods to facilitate patient access to breakthrough technologies. High caliber scientific input is essential to regulatory decision making involving increasing technologically complex medical devices. An improved scientific information base would enable FDA to keep abreast of the latest scientific advances and more effectively carry out its public health mission as it relates to medical devices and radiological products.

• FDA will intensify research and scientific collaborations in break-through technologies such as minimally and non-invasive surgical techniques and computerized technologies. FDA will expand collaborations with internationally recognized research Centers to focus their activities in device areas that will soon be exploited. The results of this work will position the Agency to ask the right questions correctly when reviewing product applications.

• Collaborate with the industry and user groups to develop comprehensive test methods and performance requirements for existing or soon-to-be developed critical device and radiological products safety standards to support premarket and postmarket decisions on device products. FDA will focus efforts on devices that are important to critical populations such as the elderly and neonates. This will minimize the amount of information manufacturers will have to provide in premarket submissions. (Devices Performance Goal # 7)

Provide quicker access to important, life-saving and health-enhancing medical devices, while assuring their safety and effectiveness.³ (Devices Strategic Goal # 1)

POSTMARKET INITIATIVES + $8.0 MILLION, 29 FTE

Medical Errors + $4.0 million, 4 FTE

• Implement the second phase pilot of the FDA Medical Surveillance Network (MeDSuN) aimed at improving the protection of the health and safety of patients, users, and others who use FDA regulated products. FDA will recruit and train at least 200-250 reporting hospitals and other clinical sites to form a national sentinel network for reporting adverse events involving FDA regulated products. The system is designed to reduce or eliminate the barriers to reporting to expand the information received by FDA. Sites would first be trained to recognize and report adverse events and "near misses" related to medical devices. The reporting of incidents that did not result in patient harm (near misses) is critical in improving patient safety. As additional sites are added to the network, training would be expanded to include human drug reactions, biologics, medical foods and other FDA regulated products. (Devices Performance Goal # 13)

³ We have attempted to align the budget request and performance plan goals. All italicized items represent performance goals in the Agency's performance plan, with the specific reference following. More information on these goals and past performance can be found in the performance plan.

• Develop standards and testing requirements to reduce errors resulting from name or packaging confusion. This is consistent with the findings of the National Academy of Sciences report on medical errors. Furthermore, this is a noteworthy problem for medical device products because medical devices are complex and are often used under stressful conditions. Also, some devices that were originally designed for use by medical personnel are now being used by lay users.

• The additional funding will enable FDA to leverage the adverse event reporting experience of a nationwide hospital network, and use the information to provide risk communication messages to health care providers and patients who use medical device products and to take regulatory steps to correct product design and design manufacturing. FDA will also develop standards and testing requirements that incorporate human error factors into both the manufacturing process and review of the products before approval for marketing. (Devices Performance Goal # 13)

Inspectional Activities + $4.0 million, 25 FTE

• Increase funding to inspect Class II and III manufacturers for both domestic and foreign manufacturers. Although the increase will improve product safety and systems conformance, FDA will not come close to meeting its statutory requirement of inspecting 50 percent of all Class II and III device manufacturers each year. Device and radiological health inspection resources have been reduced by 23 percent since FY 1995, and at the same time, the industry has grown by 30 percent. Violation rates among higher risk firms have continued to rise. (Devices Performance Goals # 8, 9)
• FDA will continue reengineering and grassroots initiatives, and utilizing leveraging opportunities, to enable the field to make the best use of device inspections and resources. FDA will expand the use of state contracts to assist the Agency in meeting its statutory biennial inspection obligations by increasing the number of state contracts for device manufacturers inspections. Even with these improvements and the requested increase in funding, FDA will not meet its biennial statutory requirement for inspections. Due to industry growth and absorption of current services, we will barely stay even. (Devices Performance Goal # 8)

FDA Device Inspections Goals

• Continue implementing the FDAMA mandated Mutual Recognition Agreement (MRA). FDA strongly endorses the MRA and believes that the extensive training of the EU assessment bodies and full implementation of the MRA will strengthen international product quality assurance and eventually reduce the number of foreign firms that FDA will need to inspect. (Devices Performance Goal # 10)

Reduce the risk of medical devices and radiation emitting products on the market by assuring product quality and correcting problems associated with their production and use. (Devices Strategic Goal # 2)

USER FEES

Proposed New User Fees

PREMARKET

Premarket Medical Device Additive User Fees⁴ + $ 5.8 million, 30 FTE

The Food and Drug Administration Modernization Act of 1997 (FDAMA) established a mechanism for third party reviews of 510k submissions. The expectation for this new mechanism was greater efficiencies for both FDA and industry, and earlier patient access to new products. Over the past two years, FDA has offered an extensive list of devices eligible for third party review, has accredited a number of third party reviewers, and has confirmed the performance of third party reviewers to be excellent, both in terms of quality and timeliness. But despite these achievements, a negligible share (3 percent) of the eligible submissions are taking advantage of this new mechanism. Because fuller implementation has so much potential benefit to all parties, FDA has developed this initiative to overcome the obvious obstacles to fuller utilization. The goal is to encourage a majority of eligible reviews to be performed by third parties over the next two years at a review pace substantially quicker than FDA's current in-house review capabilities.

⁴ The user fee as described is a proposal, and the language that is transmitted to Congress may differ from what is contained in this Justification.

There are two major impediments to fuller utilization of the third party review mechanism. Medical device manufacturers with eligible 510(k) applications currently face a cost disincentive if they choose to use the third party review option created by FDAMA. These firms, mostly small businesses, face a choice between a substantial out-of-pocket expenditure for a third party review and a free FDA review, and most choose the FDA review. In addition to this cost barrier, there are information barriers. Potential third party review users must recognize their eligibility, devote time and resources to understand the potential varied third party services, obtain cost bids, and then eventually contract for the 510(k) review. Besides the time and effort of these steps, the typical small firm will face considerable uncertainties and knowledge gaps regarding this unfamiliar process. The combination of these information barriers, coupled with the cost barrier discourages 97 percent of potential applicants from using third party review, even though these reviews have been demonstrated to be substantially quicker than conventional FDA reviews, and thus, potentially cost-effective in terms of accelerated market access.

The proposed initiative will address both information barriers and cost barriers that have stalled the growth of the market for third party reviews. Key provisions of the proposed 3-year program include:

• Reducing information barriers to third party review by constructing a virtual electronic marketplace where fully informed applicants can quickly and knowledgeably initiate third party reviews. This includes:

• Early recognition of eligibility and opportunity for third party review, and streamlined process for evaluating available review services, with current postings of third party review capabilities and services for both existing and newly accredited third parties.

• Reliable cost information for third party services based on audited cost information.

• Continuous real-time dissemination of third party performance information, including review timeliness and congruence with FDA decisions.

• Reducing the cost barrier to third party review by providing funding support, cost/performance options and greater market intelligence for potential applicants. This includes:

• Providing the first $4,000 of third party review costs⁵ for eligible submissions.

• Giving applicants more choices: Those who elect funding support will be in a better financial position to consider a range of review speed options from competing third party reviewers. Applicants also have the option to forego the funding support for a third party review and have FDA perform the review.
• Promoting greater transparency for applicants who will purchase review services, by providing comparable cost information for the accredited third party services. 

The proposed program will act as a market catalyst to transform a fledgling market for third party reviews to a mature and self-sustaining service industry. By the end of the three-year period FDA anticipates that most potentially eligible devices will be on the established FDA list, and the vast majority of eligible reviews will be performed by third party reviewers. This will provide a volume of reviews that yields economies of scale for the review services, and competitive pricing for 510(k) applicants seeking third party review. At the end of the program FDA will perform an evaluation and report to Congress on the achievement of these goals.  

The program will be funded by a user fee applied to nearly 3,000 510(k)s, with exemptions for some specialized categories and for first-time submissions. The fee would be $2,000 per submission. This fee will generate $5.83 million in revenues. Most of these funds, $4 million will be devoted to eliminating the cost disincentive. The remaining $1.83 million will be devoted to 7 FTE and $0.5 million in contract support to eliminate the information barriers. (Devices Performance Goals # 3, 4)

Current Law User Fees + $0.3 million

POSTMARKET

Mammography Quality Standards Act (MQSA) + $0.3 million

The Mammography Quality Standards Act of 1992 was reauthorized in 1998 for an additional five years (P.L. 105-298). FDA requests an increase of $0.3 million in MQSA authorized inspection user fees to cover inflation, for a total of $15.1 million with 50 FTE in FY 2001. The fees collected will pay for the costs of the inspections. (Devices Performance Goal # 12)

SPECIAL PROGRAM INITIATIVES

Countering Bioterrorism + $0.8 million, 2 FTE

FDA plays a critical role in the preparation for bioterrorist attacks by reviewing products to counter the effects of anthrax and other potential bioterrorism events. The Agency must also conduct Good Manufacturing Practice inspections of manufacturers whose products may be stockpiled as a part of the government's bioterrorist efforts. As part of the interagency effort FDA intends to:

• Prepare expert reviewers for a significant increase in the number of premarket submissions, (many as IDE applications) as the bioterrorism response program progresses.

• Monitor and evaluate the public health needs and impact of products used in conjunction with bioterrorism response (in vitro diagnostic devices, portable ventilators, syringes, gloves, and other standard equipment).

JUSTIFICATION OF BASE

• Carry out the primary goals under the Medical Devices and Radiological Products program to ensure the safety and effectiveness of medical devices and to eliminate unnecessary exposure to radiation from medical, industrial, and consumer products while maximizing the benefits from necessary exposure. 

• Ensure the safety, effectiveness, and proper labeling of medical and radiation-emitting devices.

• Enhance performance in the medical device program by actively implementing the requirements of the FDA Modernization Act of 1997 (FDAMA) and expanding reengineering efforts as priority initiatives.

• Provide direct science support to the device review process and to promote increased acceptance of consensus standards in support of FDA product review and evaluation activities. (Devices Performance Goal # 7)

• Maintain an active compliance and surveillance program that uses a scientific workforce that is proactive as well as reactive so that public health risks are scientifically identified and promptly eliminated.

• Conduct domestic and foreign inspections for Class II and Class III higher-risk medical devices and monitor imports. The concentration will be on more serious problems. FDA will not be doing any routine Class I inspections. (Devices Performance Goals # 8, 10)

• Conduct research to provide a sound foundation for effective regulation by increasing FDA's understanding of the principles at work in and the risks involved with complex devices and radiation emitting products. Engage in proactive collaborations with other government science agencies and academia where necessary to leverage FDA's scientific expertise.

• Ensure that mammography facilities remain in compliance with established quality standards and to improve the quality of mammography in the United States by conducting 9,100 inspections and 3,581 certifications. (Devices Performance Goal # 12)

• Provide technical assistance to small medical device manufacturers.

• Develop and enforce regulatory standards to limit unnecessary radiation exposure and establish criteria and scientific methods to maximize the effectiveness of useful radiation exposure. (Devices Performance Goal # 11)

• Continue FDA's presence and role in harmonizing regulatory requirements, including implementing the Mutual Recognition Agreement (MRA) with the European Union.

Devices and Radiological Health

Selected FY 1999 Accomplishments

Provided Greater Patient Access to New Medical Device Products:

• Humanitarian Use Devices (HDEs) provide an easier approval path for devices used to treat rare conditions or diseases. Approved six HDEs, including two septal occlusion devices for closing holes between the left and right sides of the heart, a sacral nerve stimulator to aid in urination and bowel evacuation in spinal cord injured patients, and a pulmonary valve for children under age 4 with absent or diseased valves.

• Exempted more than 60 Class II types of medical devices from premarket notification requirements enable manufacturers to get the products to the market and patients quicker.

Instituted More Effective Management of FDA's Resources:

• Third Party Reviews encourage access and use of outside scientific and technical expertise, and provide an alternative to FDA review. To date, FDA has recognized 13 third party bodies and made 154 types (mostly Class IIs) of devices eligible for third party review. In FY 1999, FDA received only 32 510(k)s with a third party review, but more than 1,200 were eligible.

• Abbreviated and Special 510(k) Submissions provide manufacturers with reengineered submission procedures, that are simpler to process than the traditional 510(k)s, allowing more rapid market clearance. Received 396 Special 510(k) applications and 85 Abbreviated 510(k) submissions. The Agency hopes that submission rates for these types of applications will increase.

• Least Burdensome draft guidance, involved a collaborative effort with FDA stakeholders to identify tools and principles to be used in considering the "least burdensome" means that will allow appropriate premarket development and review of a product without unnecessary delays and expense to manufacturers.

• Dispute Resolution provides an avenue for manufacturers who decide not to accept a decision or action to have it reviewed and reconsidered. Developed two guidance documents that provide an overview of dispute resolution processes and information on the use of the Medical Devices Dispute Resolution Panel. An ombudsman/quality assurance manager serves as the primary mediator in disputes involving the regulated industry with support from FDA.

Premarket Review Activities:  

• Successfully reviewed applications such that there were no overdue submissions for the third consecutive year, despite increasingly complex device application submissions.

Approved:

• Septal occlusion system, a transvascular method used in a selected population for closing holes between the left and right sides of the heart (Two HDEs: Cardioseal Septal Occlusion Systems, both by Nitinol Medical Technologies, Inc.).

• Hepatitis C Home Use Test Kits by Home Access Health Corporation.

• A new version of the HER-2 (PanVision™ HER-2 DNA Probe Kit by Vysis, Inc.) used as the basis upon which women were identified for treatment for breast cancer.

• Intrastromal corneal rings, removable implants for treating mild myopia (Intacs™ Intrastromal Corneal Ring Segments for Myopia by KeraVision, Inc.)

• Mapping systems for diagnosing complex atrial arrhythmias so that appropriate treatment can be planned (two companies - Ensite 3000 system by Endocardial solutions, Inc. and Tracer O-T-W Mapping Device by Cardima, Inc.)

Science and Standards Activities

• Cardiac Ablation. Developed a unique system to measure the parameters affecting the size and shape of lesions generated using radio frequency cardiac ablation. This system tests the effects of applying variable electrical power and changes in blood pressure and flow. This work contributed directly to the development of a guidance document on cardiac ablation.

• Interference of Cardiac Pacemakers from Cellular Telephones. Developed a test system including a simulated cellular phone and a torso simulator (salt-water tank) to enable repeatable laboratory measurements of electromagnetic compatibility (EMC) between pacemakers and cellular phones. This work formed the basis of the proposed final draft EMC standard for implantable cardiac pacemakers and defibrillators by the Association for the Advancement of Medical Instrumentation.

• Digital Mammography. Conducted significant research in both the pre-clinical and clinical stages to assist in the evaluation of digital mammography, a technique which shows promise in improving breast cancer diagnosis.

• Natural Rubber Latex. Completed development of an ELISA Inhibition Test protocol for measuring natural rubber latex (NRL) proteins, which are responsible for allergy to latex. This method has been shown to be a more sensitive assay for quantifying NRL proteins than those currently in use. The method has been submitted to the American Society for Testing and Materials (ASTM) for consideration by the committees responsible for standards on gloves and condoms.

• Proposed a strategy to classify disposable medical devices on a risk based categorization system that considers (1) the complexity of procedures associated with reprocessing the device; (2) the actual and potential risk for infection should the reprocessed device be reused; and (3) the quality and extent of published data on reprocessing for the specific device. The degree of risk associated with the reused device would determine FDA's enforcement strategy for those devices.

• FDA and CDC issued a Public Health Advisory on September 10, 1999 - Infections from Endoscopes Inadequately Reprocessed by an Automatic Endoscope Reprocessor (AER). 

Medical Error Reduction Activities

• Published guidance to manufacturers for integrating human factors into risk management for medical device design and development;

• Conducted research to improve patient labeling; and

• Developed Human Factors Engineering (HFE) design process standards with the Association for the Advancement of Medical Instrumentation (AAMI) and International Electrotechnical Commission (IEC). These standards will aid manufactures in setting up design process programs to comply with the FDA Quality System Regulation and ISO 9000.

US/EU Mutual Recognition Agreement (MRA)

• Continued to implement the MRA with the European Union (EU), which facilitates transatlantic trade and reduces industry costs for compliance with regulatory requirements. Activities are currently taking place to prepare third parties in the EU to perform work in the EU for FDA and to prepare third parties in the US to perform work in the US for the EU.

• Posted a web site dedicated to MRA activities, including the implementation plan, eligible device lists, MRA meeting minutes, and the list of nominated US and EU Conformity Assessment Bodies (CABs) that are participating in confidence building activities at http://www.fda.gov/cdrh/mra/index.html.

Mammography

• Strengthened the Mammography Quality Standards Act (MQSA) requirements, requiring that a written summary of results in lay language be provided to all patients within 30 days and mammography facilities must transfer original mammograms to the patient's physician or to the patient on request.

• Drafted proposed regulations for the "States as Certifiers" Program which are projected to be published in the Federal Register for public comment in the summer of 2000.

• Implemented a MQSA Policy Help System that will provide a clearinghouse for all MQSA regulatory guidance material and other related informational documents. The system will provide an online resource for facilities to access via the FDA Internet.

• Trained 244 and certified 16 MQSA inspectors. MQSA maintained approximately 240 inspectors throughout FY 1999.

• Issued 5,499 MQSA three-year facility certificates and conducted 9,488 facility inspections.

• Performed 170 audit inspections under the Inspector Quality Assurance Program.

• Hosted a MQSA Satellite Teleconference in February 1999 that provided an interactive platform for over 2,000 viewers to get answers to questions about regulatory requirements.

• Established a web site containing all MQSA program materials, including guidance and the quarterly newsletter, Mammography Matters.

Postmarket activities:

• Took the following actions in support of our regulatory activities:

• Quality System Inspection Technique (QSIT). Worked with the medical device industry to reengineer the process used for Quality System inspections. The new technique significantly reduces the inspection time, increases the effectiveness of the inspections, and is an essential tool for dealing a growing industry.

• Warning Letter Pilot Test. Implemented the Warning Letter Pilot Test, which allows firms 15 days to respond to and/or correct problems identified during an inspection. FDA does not issue warning letters if the problems are adequately corrected and believes that this is beneficial in getting firms to correct problems quickly.

• Draft Guidance on theLikelihood of Facilities Inspections When Modifying Devices Subject to PMA Approval. Published draft guidance for public comment in the Federal Register. During FDA/medical device industry grassroots forums, industry representatives discussed the uncertainty about FDA policy on modifying a device and what circumstances required the submission of a PMA supplement, when an inspection may be required, and when documenting the change in the firm's files may be adequate. FDA anticipates that this guidance would help reduce regulatory burdens, help manufacturers to determine when an FDA inspection will occur, and more easily implement appropriate anufacturing changes. As a result, in some cases, no inspection will be necessary.

Medical Device Reporting

• Received over 90,000 voluntary and mandatory reports.

• Issued reporting exemptions to manufactures of various medical device products to allow manufacturers to submit quarterly reports on specified adverse events in a summary form. FDA took steps to further reduce the reporting burden on industry and the FDA by enhancing the current system with the new Alternative Summary Reporting (ASR) system that will allow summary data elements to be submitted in line-item format.

Radiation Safety

• FDA and State inspectors conducted 1,124 Radiological Surveys, and found 160 systems noncompliant with one or more federal performance standards. Of the 160 systems found noncompliant, 77 systems have been corrected at no cost to the user and the remaining 83 systems are pending correction.

• FDA concluded a Memorandum of Understanding with the Federal Aviation Administration (FAA) delineating respective responsibilities in dealing with the questions of safety to air traffic as threatened by the operation of laser light shows and displays in navigable airspace.

• FDA collaborated with the Customs Service and other Federal and state agencies to advance x-ray technology applications in security and contraband deletion.

• Evaluated and approved five Corrective Action Programs of manufacturers of violative x-ray systems. The manufacturers implemented recall actions to correct their violative systems and modified production methods.

• Worked with stakeholders to identify what actions refurbishers and re-manufactures of diagnostic x-ray equipment need to take to assure that their products meet the certification requirements of the performance standards for electronic products.

Y2K as it Relates to Medical Devices: Worked with the medical device industry, the health care community and other federal agencies to ensure that the date change to the Year 2000 would adversely impact the delivery of health care related to the functioning of medical devices. Specifically, FDA:

• Identified and listed on the web, around 80 types of devices that are potentially high risk and could cause serious problems if they fail, such as fetal cardiac monitors, emergency ventilators, and radiation therapy planning systems.

• Developed plans and identified staff to rapidly respond to reports of device performance problems or potential supply disruptions due to Y2K problems.

• Conducted focused, on-site assessments reviews of a sample of manufactures for computer controlled, potentially high-risk devices to help assure that the device manufacturers have adequately assessed Y2K vulnerable products.

Selected FY 1999 Field Accomplishments

Import Alerts on non-sterile plastic bandages (IA 79-01); Class III medical devices that are not covered by FDA approval (IA 89-11); and laser pointers and laser key chains (IA 95-04).

Inspectional Initiatives:

Completed inspections of manufacturers of medical devices including TVs, microwaves, computer monitors, and military blood bank and MQSA facilities. Investigators conduct domestic and foreign inspections. Many inspections have a two-fold function of assuring the compliance status of these countries, as well as assessing the capabilities of the foreign government's regulatory authorities to effectively regulate the industry.

Devices and Radiological Health

Program Activity Data

* FY 2000 is a down year in the cycle of accreditation and certification with a broad peak in the other two years.

Edited 3/1/2000