Economic and Small Business Impact The ability of medical device establishments to pass on the added cost of the final regulation will determine the economic impact to the industry. Several comments received on proposed Sec. The establishment of quality objectives, the translation of such objectives into actual methods and procedures, and the implementation of the quality system may be delegated. As noted, the process control requirements apply when any deviation from specifications could occur. Deleted the definition of End of life in response to the many written comments and oral testimony at the August and September 1995 meetings.
This part establishes basic requirements applicable to manufacturers of finished medical devices. The maximum price increase was calculated using aggregate compliance costs as a percentage of the value of shipments. Design validation shall include software validation and risk analysis, where appropriate. Management with executive responsibility shall appoint, and document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for: i Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and ii Reporting on the performance of the quality system to management with executive responsibility for review. The effect of molecular structure on properties is discussed, along with the processing of bioresorbable and other polymers for medical applications. The agency notes, however, that the manufacturer's traceability procedures should ensure that a complete history of the device, including environmental conditions which could cause the device to fail to conform to its specified requirements, can be traced and should facilitate investigation of quality problems and corrective action.
It also specifies new as well as revised technical specifications for electrical and mechanical hazards, also new product labeling and documentation requirements. The manufacturer may choose to set up a system by which the identification required by Sec. The E-mail message field is required. The requirement does not preclude manufacturers from using automated readers where that process is followed by human oversight. Medical devices play an important role in the field of medical and health technology, and encompass a wide range of health care products. Another comment stated that labeling and packaging requirements should be in subpart K of part 820 and handling, storage, distribution, and installation requirements should be in subpart L of part 820 because labeling and packaging functionally occur before distribution and installation. The output includes the device, its labeling and packaging, associated specifications and drawings, and production and quality assurance specifications and procedures.
Manufacturers should not use prototypes developed in the laboratory or machine shop as test units to meet these requirements. These distinctive capabilities afforded by 3D printing have introduced new regulatory challenges. Tools for conducting such analyses include Failure Mode Effect Analysis and Fault Tree Analysis, among others. Several comments on proposed Sec. These basic requirements are necessary to assure the proper device performance, and, therefore, the production of safe and effective devices, and are acknowledged and accepted as such throughout the world.
A few comments stated that the requirements in proposed Sec. Chapters in the book cover materials used in medical implants, such as Titanium Oxide, polyurethane, and advanced polymers; devices for specific applications such as spinal and craniofacial implants, and other issues related to medical devices, such as precision machining and integrated telemedicine systems. Polymers as an alternative to metals -- 7. Written comments on the information collection requirements should be submitted by December 6, 1996. Software must be validated when it is a part of the finished device. Rather, the regulation provides the framework that all manufacturers must follow by requiring that manufacturers develop and follow procedures and fill in the details that are appropriate to a given device according to the current state-of-the-art manufacturing for that specific device.
When going from laboratory to scale-up production, standards, methods, and procedures may not be properly transferred, or additional manufacturing processes may be added. The procedures shall provide for the following: a Document approval and distribution. A few comments on proposed Sec. Manufacturers of human blood and blood components are not subject to this part, but are subject to part 606 of this chapter. . Design output shall be documented, reviewed, and approved before release.
Prototypes may differ from the finished production devices. Manufacturers must realize that conducting effective quality audits is crucial. Several comments stated that the proposed requirements are not necessary for all manufacturers, particularly small manufacturers with few employees and low-risk devices. However, if the manufacturer does not employ sufficient personnel, or personnel with the necessary qualifications to carry out their functions, the manufacturer will be in violation of the regulation. If there is some reason that the information described in Sec. Under this section, a manufacturer's requirements must not permit unclean or inappropriately clothed employees, or employees with medical conditions, to work with devices where such conditions could reasonably be expected to have an adverse effect on product quality.
In addition, revisions were made to many requirements in the final rule to make it less prescriptive and to allow establishments greater flexibility in implementing the requirements. Estimated price increases ranged from 0. One comment stated that the requirements in proposed Sec. The final verification and validation, therefore, must include the testing of actual production devices under actual or simulated use conditions. One comment stated that signatures should not be the only approved method for identification of the individual s responsible for release. Polyurethane for drug-controlled delivery -- 3. Several comments on proposed Sec.
An important part of risk analysis is ensuring that changes made to eliminate or minimize hazards do not introduce new hazards. Numerous comments were received on the servicing requirements that were proposed. The overwhelming majority of the committee members believed that the Working Draft met the public health needs, gave manufacturers sufficient flexibility to comply with the regulation, and met the agency's goal of harmonizing the quality system requirements with those of other countries. One comment stated that the definition should allow reference to records containing the design history of the device. The total finished design output consists of the device, its packaging and labeling, and the device master record.
For the first time, an attempt has been made to include all the theoretical data for each topic with solved numerical examples. Those relatively few devices, while class I, require close control of the design process to ensure that the devices perform as intended, given the serious consequences that could occur if their designs were flawed and the devices were to fail to meet their intended uses. Purchasing documents shall include, where possible, an agreement that the suppliers, contractors, and consultants agree to notify the manufacturer of changes in the product or service so that manufacturers may determine whether the changes may affect the quality of a finished device. Design output includes, among other things, the specifications for the manufacturing process, the quality assurance testing, and the device labeling and packaging. Kessler, Commissioner of Food and Drugs. This difference in approach does not represent any fundamentally different requirements that would hinder global harmonization.