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U.S. Department of Health and Human Services

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OCD FY2003: Regulatory Science and Standards: Science and Technology

Science and Technology Activities and Accomplishments

The CDRH Office of Science and Engineering Laboratories (OSEL) supports the scientific basis for the agency’s regulatory decision-making by developing independent laboratory information for regulatory and other public health activities of the CDRH. The Office is responsible for developing and supplying expertise on key FDA-specific scientific and technical concerns; for providing CDRH with independent data for premarket analysis and regulatory enforcement, allowing the Center to be free of overdependence on regulated industry as the sole source of performance data; and to identify the right scientific questions and develop reliable testing methods. The Office also is forging increased internal collaborations with other Center offices, such as the Office of Surveillance and Biometrics and the Office of Device Evaluation, and extramural collaborations, such as with the National Institute of Biomedical Imaging and Bioengineering (NIBIB) and AdvaMed.

One segment of the Office, the Division of Biology, relocates to the brand new FDA Life Science facility at the White Oak campus in November 2003. Approximately 50 employees, contractors, and students will begin to set up the biology laboratories for CDRH. CDRH staff is working in a coordinated effort to ensure that working conditions, furniture and equipment installations and necessary information technology, health and safety and security procedures are in place for the upcoming move to White Oak.

Program areas active in FY 03 include:

  • Genomic and Genetic Devices - The Genomic and Genetic Devices program area focuses its expertise on the newly developing areas of human genetics and genomics. This new area includes the integration of genetic information into routine medical practice, e.g., for use in optimizing individual therapies; and using the new technologies to address the issues of safety and efficacy of products undergoing premarket review and postmarketing issues such as adverse responses.
  • Host Response: Tissue-Materials Interactions, Tissue-Device Interactions - This program encompasses an interconnected program of laboratory research, risk assessment, and standards development activities designed to provide a scientific basis for regulatory decision making in CDRH. It encompasses three major areas:
    ­ Biological Effects of Chemicals and Medical Device Materials
    ­ Research to Support Risk Assessment
    ­ Infection Control
  • Biological Risk Assessment - Risk assessment is the process of determining the extent of human health hazard relative to exposure conditions. Staff in this program area conduct research to address CDRH’s regulatory need for improved methods of detecting and quantifying specific risks:
    ­ Chemical compounds released from medical device materials
    ­ Microorganisms associated with medical devices
    ­ Exposure to radiation
  • Biotechnology and Biomolecular Studies - Research in this program is designed and conducted to address safety concerns about current and impending submissions of combination products, including the importance of possible immunotoxic reactions to incorporated biomaterials. The goal of these studies is to develop critical issues in the emerging field of combination products (i.e., biological matrices used in wound healing); issues in cardiovascular surgery; and issues addressing cell encapsulation. These studies will also address the potential of combination products to cause chronic inflammation.
  • Materials Characterization and Polymer Degradation - Under this program research and testing is conducted in support of the Center’s mission-related activities in the areas of materials characterization, degradation, and materials-tissue interactions. The primary focus of the program is to characterize materials’ composition, degradation, and stability to ensure safety in use. Several models of materials degradation have been developed to predict the effect of the human body on materials in terms of degradation routes and ultimate outcome of degradation products, including unidentified particles in PVC blood bags, defective IV set fabrication, Intergel Adhesion Barrier and counterfeit polypropylene hernia repair mesh.
  • Fluid Dynamics and Ultrasonics - Much of the research in this program area focuses on test method development that examines specific device attributes. The medical products in this area are among the most complex that the Center evaluates, and their public health significance is often profound. Similarly, the rapid growth of diagnostic techniques and minimally invasive therapies drives current work in ultrasonics. Projects in this program include collaborative work with standards groups for test method development. An ongoing example is the performance assessment of heart valve hydrodynamics task in the heart valve project. In the area of ultrasonics, OSEL personnel have helped draft measurement standards for all forms of medical ultrasound except for high intensity focused ultrasound (HIFU), which is a primary focus of current research.
  • Electrophysiology and Electrical Stimulation – Investigations of the electrophysiology and electrical stimulation program area focus on clarifying the interaction mechanisms of this technology with the body, e.g., drug interactions with cardiac stimulation devices and high-frequency stimulation. Specific areas of research, which will serve as a basis for establishing industry safety standards for electrical stimulation devices, include the cellular basis of electrical stimulation safety in nerve and heart, cardiac electrophysiology and defibrillation, and retinal electrophysiology and stimulation.
  • Radiation Bioeffects -The goal of the radiation bioeffects program is to develop scientifically-based criteria for evaluating radiation-emitting medical devices and consumer products and for developing relevant CDRH/FDA guidelines and standards. Program scientists are closely involved with the national and international standards committees that promulgate standards for exposure to ionizing and non-ionizing radiation. In addition to CDRH programs, the bioeffects effort is currently providing support to CFSAN, NCI, the Federal Communications Commission, and the Department of Defense. OSEL maintains the FDA Human Photosciences Facility fully equipped for clinical research in dermatology and photomedicine. It is currently used by researchers from CDRH, CFSAN, and NCI, with NCTR involvement, to generate scientific data for modernization of the FDA policies in the area. It is available for other human studies.
  • Medical Imaging and Diagnostics - A wide variety of new digital imaging and display devices with a broad range of performance characteristics is under development by academia and industry. OSEL scientists are developing evaluation methodologies for diagnostic medical imaging systems such as mammography and fluoroscopy, computed tomography, nuclear medicine, diagnostic ultrasound, and magnetic resonance imaging, as well as novel soft-copy display devices for viewing medical images. Expertise developed through this program is being applied to the following:
    ­ Review of PMAs for ultrasound bone sonometers and new digital radiographic imaging systems
    ­ Development of amendments to the diagnostic x-ray performance standard
    ­ Development of an advisory pertaining to pediatric CT exposures, and
    ­ Joint planning of a consensus development conference on CT with NIH
    The x-ray spectral measurements program provides a source of otherwise unavailable data to the entire mammography research community, and the investigation of computer-assisted diagnosis devices is providing the Center with the scientific foundation to effectively regulate this fast-growing field. The program has made fundamental contributions to the field of statistical analysis of diagnostic imaging and systems for computer-aided diagnosis.
  • Electrical, Electronics and Software Engineering - This program provides highly specialized technical support to Center and agency regulatory activities in the areas of electrical/electronics engineering, software engineering, and systems engineering. The program focuses on product realization, a term used by engineers to describe the process of converting a design concept into a viable product.
    ­ Regulatory support - In FY 03 staff performed substantive analysis and/or participated in on-site investigations in 17 compliance cases and provided informal guidance to investigators in numerous other situations.
    ­ Staff reviewed several CBER premarket applications last year and participated in an inspection of a blood bank. These activities uncovered a number of deficiencies requiring correction by the manufacturers.
    ­ Standards development - Staff participates directly in the development and/or maintenance of several of the high-profile “horizontal” standards —notably as members of the committees responsible for the IEC 60601 series and ISO 14971—as well as several “vertical” standards (e.g., apnea monitors, pulse oximeters).1 CDRH has played a leadership role in developing a new AAMI standard covering software life cycle processes and has continued to encourage AAMI, IEEE, and ISO/IEC to work jointly to develop additional guidance for the medical device software community.
    ­ Engineering support services - Staff has earned a number of patents for their innovative designs and also has developed and deployed a data acquisition system for use in a clinical study at NIH.
  • Optical Physics – Diagnostics and Therapeutic - The rapid development of medical devices employing minimally-invasive optical technologies is revolutionizing modern health care. The Optical Physics laboratory program is directed at early identification of the following:
    ­ Key scientific questions
    ­ Safety and effectiveness issues
    ­ Mechanisms of interaction for new optical diagnostic and therapeutic technologies
    This information should facilitate the development of relevant evaluation criteria early in the review process. During the 5-year period ending in December 2002, 10% of PMAs and 7% of IDEs received by CDRH were in the area of minimally invasive optical technologies. Scientists are developing analytic techniques to identify optical tissue properties by using diffuse reflectance data, evaluating fiber optic probes used in optical diagnosis, and developing mathematical models to assist in quantifying the distribution of optical energy within tissues. CDRH’s OSEL also is studying laser therapy devices in order to elucidate the mechanisms of interaction in order to maximize treatment effectiveness.
  • Electromagnetics and Wireless Technologies - This program focuses on the several needs associated with medical devices that utilize or are affected by electromagnetic (EM) fields. The wireless technology revolution together with a flood of new medical devices incorporating sensitive microelectronics is leading to a highly unstable and potentially incompatible situation. The objective of the program is to develop independent data, measurement and computational techniques, and test methods that will serve as solid scientific foundations for regulatory guidance and proposals for national and international standards. OSEL has an active program of testing high-risk medical devices for susceptibility to electromagnetic interference (EMI) emitted by a wide variety of common sources of electromagnetic fields,. Specifically:
    ­ OSEL was a principal contributor in developing the recent ANSI/AAMI consensus standard on electromagnetic compatibility for pacemakers and defibrillators, developing the primary testing procedure and providing independent laboratory data.
    ­ OSEL tested and began coordinating an international intercomparison of measurements of the absorption of wireless phone radiation in a simplified human head model. The international standard for dosimetry is being drafted under the auspices of the Institute of Electrical and Electronics Engineers (IEEE) and is chaired by an OSEL engineer.
  • Radiological Health and Safety - The scope of this program is to provide laboratory and technical support to the Center’s Radiological Health mission. It maintains measurement and calibration facilities for x-ray, laser, noncoherent optical sources, and microwave measurements. These calibration labs perform the following functions:
    ­ Provide traceability for standards enforcement measurements
    ­ Facilitate uniformity of measurements
    ­ Provide metrology expertise for premarket and postmarket issues
    Laboratory staff have been instrumental in establishing the national standard for mammography x-ray calibrations and continue to work closely with NIST. Additionally, staff have been closely involved in the effort to align the FDA standards for Lasers and Sunlamps with their international equivalents. The laboratory’s services are used for leveraging state agencies to test newly installed radiological equipment against FDA requirements, resulting in hundreds of additional inspections per year.
  • Mechanics of Materials and Structures - The Mechanics of Materials and Structures program is structured to help CDRH understand materials issues of concern in both premarket evaluations and postmarket reported adverse events. Medical device performance and safety require reliable and safe use of materials. Performance failure can result from improper material selection, inadequate stress analysis during device design, manufacturing errors, or misuse/abuse of devices. Materials of interest include synthetics like metals and polymers, materials of biological origin, and those used in tissue engineered medical products (TEMPs).

Interagency Agreements (IAG) and CRADAs

CDRH continued efforts to increase external collaborations. Examples include:

  • Models of Renal Failure and Biomarkers or Renal Injury – IAG with GovWorks for the Department of Interior
  • Development of an Assay to Detect Endocrine Disruptor of Medical Agency- IAG with the Minerals Management Service at the Department of Interior
  • Device Material and Drugs using Bisphenol A (BPA) as a Model Estrogenic Compound - IAG with U.S. Army Medical Research and Material Command (USAMRMC),
  • Electromagnetic Compatibility (EMC) of Wireless Personal Digital Assistants (PDAs) with Active Medical Devices – IAG with Telemedicine and Advanced Technology Research Center (TATRC)
  • Health Effects of RF Emissions from Wireless Phones (Mobile Units for Commercial Mobile Radio Services) – The Cellular Telecommunications Industry Association
  • Collaborative Research and Testing of Medical Implants – IAG with Armed Forces Institute of Pathology and the American Registry of Pathology
  • Investigation of Medical Device Electromagnetic Interference (EMI) from Wireless Data Devices and Interlaboratory Comparison of Radiofrequency (RF) Dosimetry Data from Hand-held Transmitters – CRADA with Mobile Manufacture Forum (Brussels, Belgium)

 Regulatory Science Activities

CLIA Activities

Congress passed the Clinical Laboratory Improvement Amendments in 1988, establishing quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test is performed. The categorization of commercially marketed in vitro diagnostic tests under CLIA has been the responsibility of the FDA since January 31, 2000. OIVD performs the CLIA complexity categorization that includes the assignment of these test systems to one of three CLIA regulatory categories (high, moderate and waived) based on their potential risk to public health. During FY 03 CDRH performed categorizations on a total of 2170 tests including 215 High, 1661 Moderate, and 194 Waived tests. FDA, CMS, and CDC are working together to publish a final rule on CLIA waiver. More information on the CLIA program can be found at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ IVDRegulatoryAssistance/ucm124105.htm.

Site Visit Program

In FY 03, ODE continued the Site Visit Program that was developed in 1993 to enhance reviewer knowledge of how specific medical devices are designed, manufactured, and tested. The program includes not only visits to medical device manufacturing firms but also to hospitals for the observation of certain devices in use. Twenty-one firms and/or hospitals were visited by 194 scientific reviewers to learn about such things as laser refractive surgery, diVinci robotic system, left ventricular assist device, catheters, anesthesiology, breast implants, vascular stents, MR-guided focused ultrasound ablation of uterine fibroids, antimicrobial testing for new surface modification, cardiac electrophysiology devices, spinal implants, fecal incontinence devices, ophthalmic contrast sensitivity, and other devices.

 Transmissible Spongiform Encephalopathy (TSE)

CDRH has been an active participant in agency TSE activities. During FY 03, the CDRH Transmissible Spongiform Encephalopathy (TSE) Working Group developed a TSE risk document to address medical device TSE risk issues. CDRH joined CDER, CBER, and CFSAN in the Center for Biologics July 17-18, 2003 FDA CBER TSE Advisory Committee (TSEAC) meeting. It was responsible for planning the medical device portion of the meeting, including recruiting speakers, developing the agenda and making presentations regarding decontamination of medical devices that have been exposed to TSE. The TSEAC meeting was evidence of the CDRH TSE WG FDA-wide collaboration. CDRH participated along with other centers in FDA - CBER, CDER and CFSAN, developed sessions and shared information.

At the TSEAC meeting, CDRH initiated a 2 hour session with the panel experts where medical device questions related to decontamination of medical devices and equipment used in manufacturing were presented to the expert CBER panel that included a CDRH ODE panel expert on infection control. CDRH participation along with the comments from the panel provided the opportunity to initiate discussion on TSE decontamination of medical devices at this public meeting with HHS, industry and international attendance. The TSEAC panel recommended a workshop to further assess the current state of knowledge of decontamination/inactivation of TSE for medical devices, facilities, and other medical applications of animal derived products. The CDRH TSE Working Group is investigating the potential benefits of an international workshop on medical device decontamination.

 Advisory Panels

The Center’s Medical Devices Advisory Committee (MDAC) with its 18 panels provide clinical and scientific advice to FDA in several areas of activity fundamental to the regulation of medical devices. The most significant of these areas of activity are to: (1) classifiy and reclassify medical devices into one of three classes based on risk, (2) review and make recommendations on premarket submissions such as Premarket Approval Applications (PMAs), Product Development Protocols (PDPs), and Premarket Notification submissions (510ks), (3) provide advice on guidance documents which convey to industry and the agency staff FDA’s expectations for studies and data for premarket review, and (4) provide input on issues or problems concerning the safety and effectiveness of medical devices.

In FY 03, CDRH held thirteen panel meetings. The panels reviewed and made recommendations on: twelve PMAs, one 510(k), two reclassification petitions, and three general issues. In FY 03, there were 12 training sessions for members and consultants. The panels reviewed PMAs for significant medical device breakthrough technologies such as a drug-coated coronary artery stent and a stair climbing wheelchair.

A new draft guidance document, “Pediatric Expertise for Advisory Panels” issued for comment on June 3, 2003. This guidance document describes the process that CDRH intends to follow to ensure that an advisory panel review of a PMA or 510(k) includes pediatric specialists on the panel, when appropriate. The website for this draft guidance document is: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ GuidanceDocuments/ucm082185.htm. This year, the Center has recruited more than twenty pediatric specialists to serve as members or consultants on an advisory panel for any premarket submission that may be indicated for use in a pediatric population.

CDRH continuously recruits highly qualified experts to serve as members and consultants on panels. Potential candidates are asked to provide detailed information concerning financial holdings, employment, and research grants and contracts to identify any potential conflict of interest. Interested individuals should send their curriculum vitae to njp@cdrh.fda.gov.

The MDAC advisory panels are key to ensuring that the agency has access to the nation’s most esteemed medical experts and to making the FDA medical device review process transparent to stakeholders. CDRH greatly appreciates the significant contributions that the advisory panel members and consultants make to the medical device review program.

 Guidance Development

Scientifically sound guidance protects and promotes public health by helping ensure manufacturers conduct the correct device performance testing and clinical trials and by enhancing FDA’s ability to review study results, bringing beneficial products to market without undue delay.

Guidance Development Templates

The need for clear science communication in guidance documents and the need for a streamlined procedure for developing certain kinds of guidance documents has led to an exceptionally useful innovation in CDRH guidance development. In collaboration with the Regulations Staff in the Office of Health and Industry Programs and the FDA Office of Chief Counsel (OCC), CDRH developed template formats for Class II special controls guidance documents. It also has developed templates for special controls for devices that are exempt from 510(k) and templates for non-special control guidance documents.

This year, CDRH also created instructions to authors of guidance, a format for concept papers for guidance developed with the use of templates and other plain language materials for science writing in CDRH.

The use of templates and these associated materials in guidance development has contributed to efforts to reclassify, more efficiently, numerous preamendments class III devices helping to reduce regulatory burden while still ensuring that the risks to health associated with the device are appropriately addressed in the premarket review. Efforts in creating templates for special controls guidance documents used in de novo classification have helped CDRH meet statutory timeframes for these submissions as well.

Risk Management in Guidance Development Templates

Guidance is an effective risk management tool and a critical element of the Commissioner’s Strategic Plan. Moreover, clear, accurate scientific communication in guidance reduces the burden on both industry and FDA. The opportunity to incorporate FDA-recognized standards in guidance provides industry and FDA with testing methods and acceptance criteria vetted by experts who represent the international device community, further ensuring clear communication and reducing the burden of regulation. CDRH guidance development templates focus on addressing the risks to health associated with the use of devices and the measures FDA has identified to mitigate those risks, measures that follow the systems theory approach, by showing how quality systems requirements, premarket review, and postmarket oversight serve together as a system of regulatory controls to assure the safety and effectiveness of devices marketed in the U.S.

Guidance Documents

During the fiscal year, Center management initiated an effort to speed the development of guidance documents in an effort to reduce regulatory burden, foster greater consistency in scientific evidence provided in premarket submissions and optimize evaluation processes to achieve the MDUFMA performance goals. CDRH began efforts to involve scientists from throughout the Center in the guidance development process. Furthermore, specific efforts are underway to insure that FDA-recognized consensus standards are fully integrated into appropriate guidance documents in an attempt to further streamline the FDA review and promote greater international harmonization.

Guidance documents and other previously issued guidance documents are available on the World Wide Web (CDRH homepage: http://www.fda.gov/MedicalDevices/default.htm) which provides easy access to the latest information and operating policies and procedures. They also may be obtained from the Division of Small Manufacturers International and Consumer Assistance (DSMICA, HFZ-200). To contact DSMICA, call 800-638-2041 or 301-443-6597; fax 301-443-8818; E-mail dsma@cdrh.fda.gov or write to DSMICA (HFZ-200, Food and Drug Administration, 1350 Piccard Drive, Rockville, Maryland 20850-4307). Many guidance documents also are available through the CDRH Facts-On-Demand (faxback service at 800-899-0381 or 301-837-0111).

Final Guidance Documents Adopted

5-Sep-03 Part 11, Electronic Records; Electronic Signatures - Scope and Application
5-Sep-03 Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems; Guidance for Industry and FDA Staff
19-Aug-03 Guidance for Industry and FDA Staff on the Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System 6
1-Aug-03 FY 04 MDUFMA Small Business Qualification Worksheet and Certification; Guidance for Industry and FDA
1-Aug-03 Implantable Middle Ear Hearing Device; Guidance for Industry and FDA
28-Jul-03 Class II Special Controls Guidance Document: Breast Lesion Documentation System; Guidance for Industry and FDA Staff
16-Jul-03 Frequently Asked Questions about the Reprocessing and Reuse of Single-Use Devices by Third-Party and Hospital Reprocessors; Three Additional Questions; Guidance for Industry, FDA Staff, Third-Party and Hospital Reprocessors
15-Jul-03 Coronary and Peripheral Arterial Diagnostic Catheters; Guidance for Industry and FDA Staff
14-Jul-03 Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices; Guidance for Industry and FDA Staff
8-Jul-03 Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices; Guidance for Industry and FDA Staff
7-Jul-03 Breath Nitric Oxide Test System - Class II Special Controls; Guidance Document
26-Jun-03 A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures; Guidance for Industry and FDA Staff
19-Jun-03 510(k) Submissions for Coagulation Instruments; Guidance for Industry and FDA Staff
3-Jun-03 Pediatric Expertise for Advisory Panels; Guidance for Industry and FDA Staff
3-Jun-03 Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA
2-Jun-03 Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA
5-May-03 Medical Device Tracking; Guidance for Industry and FDA Staff
1-May-03 Premarket Approval Application Filing Review; Guidance for Industry and FDA Staff
28-Apr-03 Implementation of the Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002 Accreditation Criteria; Guidance for Industry, FDA Staff, and Third Parties
22-Apr-03 Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations; Guidance for Industry and FDA
1-Apr-03 User Labeling for Devices that Contain Natural Rubber (21 CFR 801.437); Small Entity Compliance Guide; Guidance for Industry
31-Mar-03 Section 206 of the Medical Device User Fee and Modernization Act (MDUFMA) (New Section 502(f) of the Federal Food, Drug and Cosmetic Act) Electronic Labeling for Prescription Devices Intended for Use in Health Care Facilities; Blue Book Guidance Memorandum #G03-1
27-Mar-03 Guidance for Industry and FDA: FY 03 MDUFMA Small Business Qualification Worksheet and Certification
26-Feb-03 Analyte Specific Reagents; Small Entity Compliance Guidance; Guidance for Industry
25-Feb-03 Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplement Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Products; Guidance for Industry and FDA
11-Feb-03 Guidance for Saline, Silicone Gel, and Alternative Breast Implants; Guidance for Industry and FDA
5-Feb-03 Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA
3-Feb-03 Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff
28-Jan-03 The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #7; Guidance for Industry and FDA
16-Jan-03 Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA
31-Dec-02 Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features; Guidance for Industry and FDA
13-Dec-02 Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCo2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA
3-Dec-02 Determination of Intended Use for 510(k) Devices; Guidance for CDRH Staff
12-Nov-02 Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA
12-Nov-02 Needlesticks - Medical Device Reporting; Guidance for User Facilities, Manufacturers, and Importers
7-Nov-02 Class II Special Controls Guidance Document: Transcutaneous Air Conduction Hearing Aid System (TACHAS); Guidance for Industry and FDA
4-Oct-02 The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles; Final Guidance for FDA and Industry
3-Oct-02 Intercenter Consultative/Collaborative Review Process; Blue Book Guidance Memorandum #G02-1
16-Sep-02 Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays; Guidance for Industry and FDA

Draft Guidance Documents for Comment Purposes Only

24-Jul-03 Premarket Assessment of Pediatric Medical Devices; Draft Guidance for Industry and FDA Staff
23-Jun-03 Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002 – Identification of Manufacturer of Medical Devices; Draft Guidance for Industry and FDA Staff
15-May-03 Surgical Masks - Premarket Notification 510(k) Submissions; Draft Guidance for Industry and FDA
12-Mar-03 Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests; Draft Guidance for Industry and FDA Reviewers
27-Feb-03 Multiplex Tests for Heritable DNA Markers, Mutations and Expression Patterns; Draft Guidance for Industry and FDA Reviewers
27-Jan-03 Chemical Indicators Premarket Notification 510(k) Submissions; Draft Guidance for Industry and FDA
23-Jan-03 Collection of Race and Ethnicity Data in Clinical Trials; Draft Guidance for Industry
19-Dec-02 Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA
13-Dec-02 Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm; Draft Guidance for Industry and FDA
3-Dec-02 Determination of Intended Use for 510(k) Devices; Guidance for CDRH Staff
12-Nov-02 Draft Guidance for Industry on Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records
22-Oct-02 Class II Special Controls Guidance Document: Processed Human Dura Mater; Draft Guidance for Industry and FDA
6-Sep-02 Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals; Draft Guidance for Industry
6-Sep-02 Medical Devices Made With Polyvinylchloride (PVC) Using the Plasticizer di-(2-Ethylhexyl)phthalate (DEHP); Draft Guidance for Industry and FDA

 Standards

Some Performance Standards for the Industry

  • FDA Laser Standard – CDRH is developing a package of amendments to regulatory standards for lasers. These amendments will recast the FDA laser standard as two IEC standards with modifications. The IEC standards will be employed by reference to avoid copyright problems. When completed, this project will result in the FDA laser standard being essentially harmonized with the laser standards used by most other regulatory authorities and could be used as a model for changing other regulatory standards.
  • CDRH staff is involved with the development of the 3rd edition of IEC 60601-1, the international standard for all safety and essential performance aspects of electrical medical devices. The topics covered by the standard, and CDRH expertise, range from risk management and electromagnetic compatibility to electrical safety, mechanical hazards, and excessive temperatures. The IEC 60601-1 standard has been recognized by CDRH to be used in regulatory submissions for marketing approval. It covers hundreds of the medical devices regulated by FDA.

 1IEC 60601 is a mature and widely cited family of standards addressing requirements for safety and performance of all medical electrical devices. ISO 14971 is a seminal new standard that delineates a risk management process for medical devices. In CDRH jargon, these are examples of horizontal standards that apply to a wide range of medical devices across clinical boundaries, while vertical standards apply to one or a limited number of categories of devices within a single clinical specialty.