 |
 |
 |
FDA
Home Page | Search FDA Site |
FDA A-Z Index | Contact FDA
A. The Center for Devices and Radiological Health (CDRH) continues to maintain a zero backlog of submissions, and has reengineered its premarket review processes to provide product sponsors more regulatory alternatives for premarket submissions. The Center has made available information about the process for review of applications on the FDA web site, including 14 guidance documents and 5 rules, and is implementing FDAMA requirements that call for earlier and more frequent meetings with sponsors. A new PMA initiative, the "modular PMA", allows sponsors to submit an application in parts rather than all at once, and utilizes early meetings with industry to identify data needs and resolve issues. In addition, many device types have been exempted entirely from premarket review. There are currently 13 accredited third parties and 157 different types of devices eligible for third party review. FDA has recognized over 400 consensus standards that can be used in declarations of conformity to shorten and simplify some applications.
These initiatives, along with the implementation of FDAMA, have shifted resources from lower-risk to higher-risk areas, increased interactions with sponsors, and streamlined review processes such that the Center has improved premarket review times in every category. FDA intends to continue applying its reengineered processes and the provisions of FDAMA; however, additional improvements toward meeting statutory time frames are unlikely without additional resources.
The Center for Biologics Evaluation and Research (CBER) is implementing FDAMA initiatives that are similar to CDRH's FDAMA initiatives. On April 26, 1999, FDA published a list of documents issued by FDA that apply to Medical Devices Regulated by CBER (64 FR 20312) that included concurrence with the policies and procedures published by CDRH relating to implementation of FDAMA initiatives. During recent 406(b) Stakeholders' public meetings, certain concerns were stated by industry representatives regarding CBER's commitment to implement FDAMA and to consistently apply CDRH policy and procedures to the regulation of medical devices at CBER. Stakeholders also expressed an interest in CBER's improving its medical device review performance and its communication with industry.
CBER has developed a Device Action Plan to facilitate the implementation of the device provisions of FDAMA and to ensure that CBER and CDRH apply policies and procedures consistently. The plan will assess any differences that may exist and determine if those differences are justified in the interest of the public health. This plan addresses areas of cooperation, coordination, and communication between CBER and CDRH to assure harmonized activities. It focuses on CBER review practices and performance goals under a new managed review process. The plan also includes ongoing outreach activities to maintain input and feedback from industry and the public. The Device Action Plan was posted on CBER's Website on April 27, 1999 (www.fda.gov/cber/dap/dap.htm). CBER included device review in the new managed review process that has been implemented to address review of the new Biologics License Applications, the CBER Strategic Plan and the Vice President's Reinventing Government initiatives. Performance goals exist for all applications for approval as required by the GPRA. The review backlogs for non-PDUFA products have been steadily reduced since implementation of the previous Managed Review Process in CBER, and it is expected that this trend will continue for devices.
A. FDA's regulatory mandate is clearly different from that of OSHA. OSHA's mission is to protect the health of America's workers by establishing and enforcing protective standards and offering employers and employees technical assistance and consultative programs. FDA's statutory authority to assure that medical devices are reasonably safe and effective for their intended use does not extend to the occupational safety and health responsibilities of OSHA. FDA has no workplace inspection program.
However, in those cases where both agencies have overlapping regulatory responsibility, e.g., unshielded syringes and natural rubber latex gloves, it is imperative that the agencies work together to coordinate their efforts so that government can speak with one voice and not cause confusion for the public or for regulated industry.
For example, FDA and OSHA have a history of collaboration on reduction of sharp injuries. The interaction began in the 1980s when the OSHA Blood Borne Pathogens Rule was being formulated. This rule contains engineering control aspects that are directly related to medical devices under the jurisdiction of FDA. FDA and OSHA have jointly planned and cosponsored several healthcare worker safety conferences on sharps injuries; the most recent being held in August 1997. FDA is following up with OSHA on an action plan to address the ideas and comments raised in the August 1997 Frontline Healthcare Workers meeting. Similarly, FDA has coordinated efforts with OSHA on issues related to natural rubber latex allergies.
A. Although ISO standard 13485 is similar to the FDA's Quality Systems Regulation (QSR) in many ways, there are also significant differences. This is particularly true for complaint handling and reporting requirements that are an integral part of the QSR, but not adequately addressed by the ISO standard. Thus, a declaration of conformity to the ISO standard would not suffice to demonstrate conformity with the QSR, and CDRH will not recognize this standard for this purpose. Note that this does not preclude the potential use of ISO 13485 for other purposes.
A. The Office of Device Evaluation (ODE) in CDRH is accepting medical device applications in electronic form on diskettes or CDROM. Electronic submissions by either e-mail or by file transfer over the Internet involve security and confidentiality issues that have not been satisfactorily resolved.
ODE is currently developing formal guidelines regarding electronic submissions. Until they are finalized, CDRH is requesting industry to notify the center if it wishes to submit an application in electronic form. This lead time is needed to discuss any special considerations with the submitter prior to development of the documents. The application should be submitted in a PDF format since the ODE staff will use Acrobat Exchange to review the submission. This will assure that what a reviewer sees on the screen is the same as what would have been seen on paper. If the application would require several diskettes, the preferred medium would be a CD-ROM. Industry should also contact the Director of the ODE Division to which its device pertains. It should be understood that an electronic application does not change the order in which submissions are reviewed. No preferential treatment will be given to manufacturers who submit an electronic application. In addition, at least one paper copy of the submission is also required. Additional copies of some reports may be requested in order to help facilitate the review. Information on Electronic Submissions is available on the following Web site: www.fda.gov/cdrh/elecsub.html
A. Manufacturing plant tours are part of ODE's Site Visit Program that was started in 1993. The ODE Site Visit Program is an ODE-sponsored educational activity that allows medical device reviewers to visit manufacturing firms and observe the design and manufacturing process of the medical devices they review. Reviewers have the opportunity to query the manufacturer's scientists and engineers about the intended use, design, and maintenance of the medical devices produced, thus providing the reviewers with useful information about the device and first-hand observation of its development. Aside from the educational benefits afforded ODE reviewers, the Site Visit Program also improves communications between industry and FDA and provides both groups a better understanding of the health issues involved with medical device technology. So far, over 175 CDRH employees have visited over 39 firms and/or hospitals. To set up a manufacturing plant tour, please contact Lesa Dowtin in ODE's Program Management Office at 301-594-3055.
A. The proposed legislation submitted by the Administration would establish user fees for PMAs, PMA supplements, and annual reports. The bill does not include any fees for 510(k)s but includes a very modest registration fee ($200) for all device manufacturers. The legislation provides for exemption or reduction of fees in a variety of circumstances, including for start-up companies that have no marketed products and for humanitarian devices. These would be additive user fees that would only be assessed if the appropriated funding for the program remained constant each year. The current intent of the agency is to direct these fees to premarket staff and activities that would improve the performance of the agency with respect to timeliness of PMA reviews. User fees would also enhance the science base of the Center for premarket review activities (e.g., increased standards development activities, training on new technologies and risk assessment tools, as well as access to automated databases). FDA believes this investment in better science will lead to less burdensome and more timely reviews that are commensurate with the risk of each product.
A. The Agency recognizes the increased use of software both as a device component and as a device itself. We are committed to assuring that software used in a medical device or as a medical device is safe and effective. To this end, we have developed guidance for pre-market submissions for software-controlled devices, for use of off-the-shelf software in devices, and for validation of device software. We are also committed to the establishment of consensus standards that will help to assure safe and effective software in the medical device arena.
Classification of software that is, by itself, a medical device is one option being considered by the agency. The proposal for software device classification submitted by HIMA (Health Industry Manufacturers Association) to CDRH and CBER is currently being evaluated.
A. Silicone gel-filled breast implants are available only as part of a clinical study conducted under an Investigational Device Exemption (IDE) or under an adjunct study that was established to provide access to these breast implants for women undergoing reconstructive surgery. Once the trials are completed, a company must submit a PMA (premarket approval application) to the Agency to get approval for commercial marketing. The PMA would be reviewed by the FDA to determine whether there is a reasonable assurance of the safety and effectiveness of the device. It is important to note that FDA relies on "valid scientific evidence" when determining safety and effectiveness. Data establishing the rupture rate associated with any particular breast implant would certainly be considered as part of this review. However, FDA typically does not set pre-defined failure rates that it considers acceptable or not acceptable when reviewing PMAs.
A. The MedWatch reporting system relies on healthcare professionals and consumers to feed it information. There are ongoing efforts to improve postmarket surveillance, including the proposed Medical Device Surveillance Network (MedSun). This is a network that will enable user facilities to improve and to increase reporting of adverse events associated with medical devices. However, the MDR system is generally not a suitable data system for evaluating "the long term consequences of implants." MDR is very useful for finding signals of public health problems. In fact, the instances of rupture reported to MDR were one very important impetus for FDA to study rupture. FDA has made a significant investment in a study of breast implant rupture and the results from that study are anticipated this summer or fall.
Within CDRH, postmarket reengineering efforts are underway to determine the best ways to receive and utilize data from adverse event reports. With respect to breast implants in particular, FDA also offers a breast implant reporting packet to all people who request it. This packet gives detailed instructions on how to fill out a MedWatch form. It also gives an example of one that is filled out for easy reference. In addition, postmarket studies for breast implants under 510(k) have been reaffirmed with the manufacturers. FDA issued orders to all manufacturers of saline breast implants that requiring the continuation of postmarket studies for these implants.