 | The examples and perspective in this article deal primarily with the United States and do not represent a worldwide view of the subject.(August 2018) |
Due to the many regulations in the industry, the design of medical devices presents significant challenges from both engineering and legal perspectives.
The United States medical device industry is one of the largest markets globally, exceeding $110 billion annually. In 2012 it represented 38% of the global market and more than 6500 medical device companies exist nationwide. These companies are primarily small-scale operations with fewer than 50 employees. The most medical device companies are in the states of California, Florida, New York, Pennsylvania, Michigan, Massachusetts, Illinois, Minnesota, and Georgia. Washington, Wisconsin, and Texas also have high employment levels in the medical device industry. [1] The industry is divided into branches: Electro-Medical Equipment, Irradiation Apparatuses, Surgical and Medical Instruments, Surgical Appliances and Supplies, and Dental Equipment and Supplies. [1]
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Medical devices are defined by the US Food and Drug Administration (FDA) as any object or component used in diagnosis, treatment, prevention, or cure of medical conditions or diseases, or affects body structure or function through means other than chemical or metabolic reaction in humans or animals. [2] This includes all medical tools, excluding drugs, ranging from tongue depressors to Computerized Axial Tomography (CAT) scanners to radiology treatments. Because of the wide variety of equipment classified as medical devices, the FDA has no single standard to which a specific device must be manufactured; instead they have created an encompassing guide that all manufacturers must follow. Manufacturers are required to develop comprehensive procedures within the FDA framework in order to produce a specific device to approved safety standards.
The US FDA allows for three regulatory pathways that allow the marketing of medical devices. The first is self-registration. [3] The second, and by far the most common is the so-called 510(k) clearance process (named after the Food, Drug, and Cosmetic Act section that describes the process). [3] A new medical device that can be demonstrated to be "substantially equivalent" to a previously legally marketed device can be "cleared" by the FDA for marketing as long as the general and special controls as described below are met. [3] The vast majority of new medical devices (99%) enter the marketplace via this process. The 510(k) pathway rarely requires clinical trials. [3]
The third regulatory pathway for new medical devices is the Premarket Approval process (PMA), described below, which is similar to the pathway for a new drug approval. Typically, clinical trials are required for this premarket approval pathway. [4]
The FDA process between drugs and devices is different, with most devices requiring clearance [3] for the market launch, not approval. Approval is required for the PMA process of Class III devices. [3]
In comparison to a device, a drug takes up to nine years longer to reach the market. [3] [5] It can take drugs up twelve years to be granted FDA approval. [3] [5] In general, for class I, II and III devices, from the design process until the final FDA market clearance, it can take anywhere from three to seven years. [3] [5]
Class I are low risk of illness or injury devices. [5] Around seventy-five percent of Class I devices, and a small number of class II devices qualify for exempt status. This means there is no requirement for safety data. [5]
Class II are devices with moderate risk. [5] Class I and Class II devices are subject to less stringent regulatory processes than Class III devices. [5] Class I or II devices are focused on registration, manufacturing, and labeling. [5] In general they do not require clinical data. [5] Most class II devices go through a PMN (a 510[k]) clearance. [5] The PMN will not require stringent clinical trial evidence. [5]
Class III are devices which support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury. [5]
All new devices by default are placed in the class III category. [5] The FDA then requires these devices to undergo stringent clinical reviews. [5] For these reviews, the FDA require some type of clinical evidence or trials. [5] If the sponsor believes the device is low to moderate risk, the sponsor may apply to change this default classification. [5] The FDA, upon review may then reclassify these devices as de novo. [5] De novo devices require a less rigorous FDA regulatory process [5] and the FDA treats de novo devices like class I and II devices. [5]
Class III devices with predicates (devices with a substantially equivalent device already on the market) are reclassified as class I or II devices. [5] This is done through a 513(g) pathway. [5] Class III devices reclassified as a class I or II, are then subject to less stringent testing requirements. [5] As reclassified class II devices they would require a PMN (501[k]) process, [5] not the PMA process. [5]
General controls include provisions that relate to:
Special controls were established for cases in which patient safety and product effectiveness are not fully guaranteed by general controls. Special controls may include special labeling requirements, mandatory performance standards and postmarket surveillance. [7] Special controls are specific to each device and classification guides are available for various branches of medical devices. [8]
Premarket Approval is a scientific review to ensure the device's safety and effectiveness, in addition to the general controls of Class I. [9] [7]
Under the Food, Drug, and Cosmetic Act, the U.S. Food and Drug Administration recognizes three classes of medical devices, based on the level of control necessary to assure safety and effectiveness. [9] The classification procedures are described in the Code of Federal Regulations, Title 21, part 860 (usually known as 21 CFR 860). [10] Devices are classified into three brackets:
Regulations differ by class based on their complexity or the potential hazards in the event of malfunction. Class I devices are the least likely to cause major bodily harm or death in the event of failure, and are subjected to less stringent regulations than are devices categorized as Class II or Class III. [11]
In the regulation process, 2021 statistics showed: 47% of devices were class I, [3] 43% were class II [3] and 10% were class III. [3]
Class I devices are subject to the least regulatory control. Class I devices are subject to "General Controls" as are Class II and Class III devices. [9] [7] [6]
General controls are the only controls regulating Class I medical devices. They state that Class I devices are not intended to be:
Most Class I devices are exempt from premarket notification and a few are also exempted from most good manufacturing practices regulations. [9] [7] [6]
Examples of Class I devices include hand-held surgical instruments, (elastic) bandages, examination gloves, bed-patient monitoring systems, medical disposable bedding, and some prosthetics such as hearing aids. [7] [13]
Class II devices are those for which general controls alone cannot assure safety and effectiveness, and existing methods are available that provide such assurances. [9] [7] Devices in Class II are held to a higher level of assurance and subject to stricter regulatory requirements than Class I devices, and are designed to perform as indicated without causing injury or harm to patient or user. In addition to complying with general controls, Class II devices are also subject to special controls. [7]
Examples of Class II devices include acupuncture needles, powered wheelchairs, infusion pumps, air purifiers, and surgical drapes. [9] [7] [14]
A few Class II devices are exempt from the premarket notification. [7]
A Class III device is one for which insufficient information exists to assure safety and effectiveness solely through the general or special controls sufficient for Class I or Class II devices. [9] [7] These devices are considered high-risk and are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, pose a potential, unreasonable risk of injury or illness, or are of great significance in preventative care. [7] For these reasons, Class III devices require premarket approval.
Prior to marketing a Class III device, the rights-holder(s) or person(s) with authorized access must seek FDA approval. The review process may exceed six months for final determination of safety by an FDA advisory committee. Many Class III devices have established guidelines for Premarket Approval (PMA) and increasingly, must comply with unique device identifier regulations. [15] However, with ongoing technological advances many Class III devices encompass concepts not previously marketed, These devices may not fit the scope of established device categories and do not yet have developed FDA guidelines. [16]
Examples of Class III devices that require a premarket notification include implantable pacemaker, pulse generators, HIV diagnostic tests, automated external defibrillators, and endosseous implants. [7]
Nanomanufacturing techniques provide a means of manufacturing cellular-scale medical devices (<100μm). They are particularly useful in the context of medical research, where cellular-scale sensors can be produced that provide high-resolution measurements of cellular-scale phenomena. [17] Common techniques in the area are direct-write nanopatterning techniques such as dip-pen nanolithography, electron-beam photolithography and microcontact printing, directed self-assembly methods, and Functional Nanoparticle Delivery (NFP), where nanofountain probes deliver liquid molecular material that is drawn through nanopattern channels by capillary action. [18]
Additive manufacturing (AM) processes are a dominant mode of production for medical devices that are used inside the body, such as implants, transplants and prostheses, for their ability to replicate organic shapes and enclosed volumes that are difficult to fabricate. [19] The inability of donation systems to meet the demand for organ transplantation in particular has led to the rise of AM in medical device manufacturing. [20]
The largest issue in integrating AM techniques into medical device manufacturing is biocompatibility. These issues arise from the stability of 3D printed polymers in the body and the difficulty of sterilizing regions between printed layers. [21] In addition to the use of primary cleaners and solvents to remove surface impurities, which are commonly isopropyl alcohol, peroxides, and bleach, [22] secondary solvents must be use in succession to remove the cleaning chemicals applied before them, a problem that increases with the porosity of the material used. [21] Common compatibility AM materials include nylon [23] and tissue material from the host patient. [22]
Many medical devices have either been successfully attacked or had potentially deadly vulnerabilities demonstrated, including both in-hospital diagnostic equipment [24] and implanted devices including pacemakers [25] and insulin pumps. [26] On 28 December 2016 the US Food and Drug Administration released its recommendations that are not legally enforceable for how medical device manufacturers should maintain the security of Internet-connected devices. [27] [28]
The United States Food and Drug Administration is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
Medical software is any software item or system used within a medical context, such as:reducing the paperwork, tracking patient activity
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality management system (QMS).
The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as in Australia.
The United States Federal Food, Drug, and Cosmetic Act is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. The FDA's principal representative with members of congress during its drafting was Charles W. Crawford. A principal author of this law was Royal S. Copeland, a three-term U.S. senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations.
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase.
An investigational device exemption (IDE) allows an investigational device to be used in order to collect safety and effectiveness data required to support a premarket approval (PMA) application or a premarket notification [510(k)] submission to Food and Drug Administration (FDA). Clinical studies are most often conducted to support a PMA. Only a small percentage of 510(k)'s require clinical data to support the application. Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated.
A drug recall removes a prescription or over-the-counter drug from the market. Drug recalls in the United States are made by the FDA or the creators of the drug when certain criteria are met. When a drug recall is made, the drug is removed from the market and potential legal action can be taken depending on the severity of the drug recall.
Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP).
Clinical research is a branch of healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Clinical research is different from clinical practice. In clinical practice established treatments are used, while in clinical research evidence is collected to establish a treatment.
The Center for Drug Evaluation and Research is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act. Some biological products are also legally considered drugs, but they are covered by the Center for Biologics Evaluation and Research. The center reviews applications for brand name, generic, and over the counter pharmaceuticals, manages US current Good Manufacturing Practice (cGMP) regulations for pharmaceutical manufacturing, determines which medications require a medical prescription, monitors advertising of approved medications, and collects and analyzes safety data about pharmaceuticals that are already on the market.
The Center for Devices and Radiological Health (CDRH) is the branch of the United States Food and Drug Administration (FDA) responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices. The CDRH also oversees the radiation safety performance of non-medical devices which emit certain types of electromagnetic radiation, such as cellular phones and microwave ovens.
Artificial disc replacement (ADR), or total disc replacement (TDR), is a type of arthroplasty. It is a surgical procedure in which degenerated intervertebral discs in the spinal column are replaced with artificial disc implants in the lumbar (lower) or cervical (upper) spine. The procedure is used to treat chronic, severe low back pain and cervical pain resulting from degenerative disc disease. Disc replacement is also an alternative intervention for symptomatic disc herniation with associated arm and hand, or leg symptoms.
President of the United States George W. Bush signed the Food and Drug Administration Amendments Act of 2007 (FDAAA) on September 27, 2007. This law reviewed, expanded, and reaffirmed several existing pieces of legislation regulating the FDA. These changes allow the FDA to perform more comprehensive reviews of potential new drugs and devices. It was sponsored by Reps. Joe Barton and Frank Pallone and passed unanimously by the Senate.
The United States Food and Drug Administration Modernization Act of 1997 (FDAMA) amended the Federal Food, Drug, and Cosmetic Act. This act is related to the regulation of food, drugs, devices, and biological products by the FDA. These changes were made in order to recognize the changes in the way the FDA would be operating in the 21st century. The main focus of this is the acknowledgment in the advancement of technological, trade, and public health complexities.
The Food and Drug Administration is a federal agency of the United States, formed in 1930.
The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) is a piece of American regulatory legislation signed into law on July 9, 2012. It gives the United States Food and Drug Administration (FDA) the authority to collect user fees from the medical industry to fund reviews of innovator drugs, medical devices, generic drugs and biosimilar biologics. It also creates the breakthrough therapy designation program and extends the priority review voucher program to make eligible rare pediatric diseases. The measure was passed by 96 senators voting for and one voting against.
The Medical Device Regulation Act or Medical Device Amendments of 1976 was introduced by the 94th Congress of the United States. Congressman Paul G. Rogers and Senator Edward M. Kennedy were the chairperson sponsors of the medical device amendments. The Title 21 amendments were signed into law on May 28, 1976, by the 38th President of the United States Gerald R. Ford.
Safe Medical Device Amendments of 1990 or Safe Medical Devices Act sanctioned progressive reporting and tracking rules for medical devices classified by the Medical Device Regulation Act. The Act mandates reporting requirements by medical device manufacturers regarding adverse safety events and product effectiveness of devices classified as substantially equivalent to Class III medical devices. The United States Statute established the Health and Human Services Office of International Relations and a U.S. Food and Drug Administration office for regulatory activities concerning healthcare products which are considered a combinational biological, device, or drug product. The Act of Congress transferred the electronic product radiation control provisions established by the Radiation Control for Health and Safety Act.
The Over-the-Counter Hearing Aid Act of 2017 was a law passed by the 115th United States Congress as a rider on the FDA Reauthorization Act of 2017. It created a class of hearing aids regulated by the Food and Drug Administration (FDA) available directly to consumers without involvement from a licensed professional. Regulations for this new class of hearing aid are expected to be released by the end of 2020.
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