OCD FY2000: Regulatory science and standards
Some of the Guidance Documents Issued For Industry
- In August 1999, we issued a draft guidance document entitled, "Electro-optical Sensors for the In Vivo Detection of Cervical Cancer and its Precursors: Submission Guidance for an IDE/PMA, Draft Guidance." This document includes the requirements for a clinical protocol based on reported medical indications. Also addressed are requirements to provide a complete description of the optical radiation aspects of the device, the calibration procedures planned and the hazard analyses of the optical radiation emissions. These requirements help both the agency and the sponsors in determining whether a device is either "Significant risk" or "Non-significant risk".
- In October 1999, we issued a guidance document entitled, "Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems" to clarify the requirement to provide assembly, installation, adjustment, and testing instructions, whether printed or software.
- In March 2000, we issued a guidance document entitled, "Use of Standards in Substantial Equivalence Determinations" clarifying how information on conformity with standards may be used to support 510(k) substantial equivalence determinations. This guidance document, along with other initiatives such as our June 2000 expansion of the 510(k) third-party review program were aimed at stimulating greater industry use of streamlined submission/review procedures. The results are encouraging—our combined receipts of abbreviated and special 510(k)s, plus third party-reviewed 510(k)s, rose from 513 in fiscal year 1999 to 778 this year, a 52-percent increase. These streamlined submissions now comprise nearly one-fifth of all 510(k) receipts. Similarly, in the PMA process, real time PMA supplements account for more than one-fourth of all PMA supplements received.
- In August 2000, we issued a guidance document entitled, "Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals." This guidance document finalizes FDA’s policy on how it intends to regulate entities that reprocess devices intended for single-use for reuse in humans. This document sets forth FDA’s priorities for enforcing premarket submission requirements, based on the device’s Code of Federal Regulations classification. Beginning on February 14, 2001, the agency will enforce premarket submission requirements for all class III single-use devices that are re-used. Beginning on August 14, 2001, and February 14, 2002, respectively, premarket submissions will be required for all non-exempt class II devices and non-exempt class I single-use devices that are re-used. . In addition to the premarket requirements, entities engaged in reprocessing of single-use devices also must comply with requirements pertaining to registration and Listing; Medical Device Reporting; Medical Device Tracking; Medical Device Corrections and Removals; Quality System Regulation; and Labeling. The findings of the laboratory studies on issues associated with the reuse of single use devices added substantially to the science base for these regulatory decisions on reuse of single use devices.
- In August 2000, we issued a guidance document entitled, "Labeling for Electronic Anti-Theft Systems". Electronic implantable medical devices may be affected by the radiated emissions of electronic anti-theft systems. The 1998 and 1999 meetings of the Technical Electronic Product Safety Standards Committee (TEPRSSC) recommended that various groups, including anti-theft system manufacturers, the medical community, and the retail industry work together to develop solutions to this issue. Although the risk of interference is low (a relatively low number of incidents of interference and primarily moderate or mild incidents), we recommend posting labeling or signage on or near anti-theft systems so that implant wearers can take appropriate precautions when entering or leaving areas containing these systems. The precautions, recommending that implant wearers "don’t linger, don’t lean" near these systems, resulted from research conducted by the medical community in collaboration with anti-theft system manufacturers. The Office of Surveillance and Biometrics notified physicians of the necessary precautions in a 1998 informational letter.
- In September 2000, we issued a guidance document entitled,"Wireless Medical Telemetry Risks and Recommendations". The guidance was drafted as part of a our Electromagnetic Compatability (EMC) Working Group action plan to endorse a recently adopted U.S. Federal Communications Commission (FCC) rule to create the Wireless Medical Telemetry Service (WMTS). The WMTS provides a spectrum for primary use by medical telemetry to reduce the risk of interference to telemetry equipment from other radiofrequency (RF) transmitters. The guidance primarily recommends that all wireless medical telemetry manufacturers conduct a risk analysis to determine whether their equipment is at risk of interference, and to take action to reduce the risk to their equipment as appropriate. The guidance also encourages manufacturers of wireless medical telemetry equipment to use the new WMTS to minimize the risk of interference from other in-band RF transmitters.
Some Performance Standards for Industry
- In May 2000, we finished implementing our first medical device performance standard entitled, "Electrode Lead Wires and Patient Cables". The standard responds to reports of patient deaths caused when the cables were accidentally plugged into110 volt wall circuits. The standard requires electrically protected connectors for electrode lead wires and patient cables to prevent unintended electrical shock or electrocution. It now applies to all medical devices that use patient connected electrodes – both new devices and devices already in use in healthcare facilities.
- We are drafting proposed amendments to our performance standard for laser products promulgated under Chapter 5, Subchapter C of the Federal Food, Drug and Cosmetic Act. The proposed amendments are intended to reduce the gap in requirements between our Center standard and that of the International Electrotechnical Commission (IEC) and the European Community (CENELEC).
- We proposed and received approval from the American National Standards Institute’s Accredited Committee N43 to develop a new standard for use of x-rays for non-medical screening of people to detect contraband and weapons. This new technology uses a small fraction of the radiation dose common in medical diagnostic procedures, but has a potential of exposing large populations to ionizing radiation. Our staff is currently working on measurement protocols for this standard.
- We served a leading role in the development of the International Organization for Standardization (ISO) performance standard for the quality and safety of ophthalmic diagnostic instruments. Standard ISO 15004 includes proposals for new emission limits, for classification of ophthalmic instruments, and performance requirements for the devices. Manufacturers will be able to certify conformance with this standard when they apply for approval of a new product.
- We participated in the review and further development of the draft ISO standards TC WG 4-14155-2, "Clinical Investigation of Medical Devices for Human Subjects, Part 1: General Requirements" and "Part 2: Clinical Investigation Plans", which cover specific requirements for the conduct and documentation of device clinical investigations. The draft ISO standards were reviewed as part of our Center’s heightened awareness of the need for universal guiding principles regarding the proper conduct of medical device clinical trials and the protection of human research subjects.
- We prepared, submitted and the American Society for Testing and Materials (ASTM) approved the test method, "Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials." This standard is applicable to safety testing for blood-contacting medical devices.
- Similarly we participated in the review and further development of the revisions of ISO TC 194 standards 10993-10 on irritation and sensitization in parallel with 10993-12 on sample preparation for universal guiding principles for preclinical evaluation of device materials. The resulting consistency between these two documents will now serve to help maintain consistency in terminology and methodology as the other 10993 documents meet their time frame for revision/renewal or in the development of new standards.
- We remain very active in the development of ASTM standards for performance or preclinical assessment of medical devices as part of ASTM F04 committees. Among these activities are new standards on biocompatibility dealing with local response to absorbable materials, complement activation, and scientific investigations leading to the revision of the F756 standard on hemolysis.
- Continued participation from laboratory studies and as members of the task group has led to development of standards for quantitating proteins and protein allergens on latex products as part of ASTM D11.40.
- We provided major technical expertise in the development and revision of the American Association for Medical Instrumentation (AAMI) standards on sterilization.