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1 1 (May 26, 2023)

handle is hein.crs/goveltx0001 and id is 1 raw text is: Con re &on I flesedrch Service horniig Aecji ivede a~m 'e1914 0 Updated May 26, 2023 Medical Product Regulation: Drugs, Biologics, and Devices The Food and Drug Administration (FDA) regulates the safety and effectiveness of drugs, biologics, and devices (medical products) pursuant to its authorities under the Federal Food, Drug and Cosmetic Act (FFDCA) and the Public Health Service Act (PHSA). Drugs and devices are approved or cleared under the FFDCA, whereas biologics are licensed under the PHSA. Small molecule or chemical drugs are chemically synthesized, while biologics are derived from living organisms. All FDA-regulated medical products conceptually meet the definition of drug. Biologics are a subset of drugs, subject to many of the same regulatory requirements. A device-an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article-also meets the definition of drug; however, unlike a drug or biologic, it does not achieve its primary intended purposes through chemical action within or on the body ... and is not dependent upon being metabolized for the achievement of its primary intended purposes (FFDCA §201(h)). FDA's Center for Biologics Evaluation and Research (CBER) oversees certain biologics (e.g., vaccines and gene therapies); the Center for Drug Evaluation and Research (CDER) oversees chemical drugs and other biologics (e.g., certain monoclonal antibodies and immunomodulators); and the Center for Devices and Radiological Health (CDRH) oversees medical devices and radiologic products. This In Focus broadly summarizes selected differences in statutory requirements among drugs, biologics, and devices. It does not address every difference and is not meant to be a comprehensive analysis of requirements. Premarket Requfrements Under most circumstances, drugs, devices, and biologics may be marketed only if they have been approved, cleared, or licensed by FDA. Prescription Drugs and Biologics To market a new drug, the sponsor (generally the manufacturer) must submit to FDA for review a new drug application (NDA) demonstrating that the drug is safe and effective for its proposed use. FDA has some discretion when determining what evidence is necessary for NDA approval. During review, FDA officials evaluate the drug's safety and effectiveness (derived from clinical trials) for its intended use; adequacy of manufacturing methods to ensure the drug's identity, strength, quality, and purity; and accuracy of the proposed labeling. Sponsors for both drug and biologic products must comply with current good manufacturing practice (CGMP) regulations, which provide minimum requirements for the methods, facilities, and controls used in manufacturing. While drugs are approved via an NDA under Section 505 of the FFDCA, biologics are licensed via a biologics license application (BLA) under Section 351 of the PHSA. To obtain licensure, the sponsor must demonstrate in the BLA that the facilities and processes for biologics manufacturing meet standards ensuring the product is safe, pure, and potent (i.e., effective). The requirements and review pathway for BLAs are generally similar to those for NDAs, and biologics are subject to certain FFDCA provisions. For prescription drugs and biologics with certain safety risks, FDA may require a risk evaluation and mitigation strategy (REMS) upon the submission of an NDA, which may include restrictions on distribution or use of the drug or biologic. Medical Devices Medical devices are regulated based on the risk posed to the consumer: Class I devices are low-risk, Class II devices are moderate-risk, and Class III devices are high-risk. Unless specifically excluded by regulation, all devices must meet general controls, which include both premarket and postmarket requirements. General controls include, for example, 510(k) premarket notification, registration, listing, and compliance with CGMPs as set forth in FDA's quality system regulation (QSR). Class II devices must meet, in addition to general controls, special controls, which are usually device-specific. Premarket special controls include performance standards and premarket data requirements. Almost all Class I devices are exempt from the 510(k) premarket notification requirement, whereas almost all Class II devices require 510(k) clearance prior to marketing. A 510(k) submission must demonstrate that a device is substantially equivalent to a legally marketed predicate device, which typically does not require submission of clinical data, although it may in certain cases. In November 2018, FDA announced proposed changes to modernize the 510(k) clearance pathway, including the preferential use of modern predicate devices and development of updated pathways. Class III devices are subject to premarket approval application (PMA) requirements, with some exceptions, in addition to general controls. FDA issues an approval order when a PMA demonstrates reasonable assurance that a device is safe and effective for its intended use(s). Safety and effectiveness must be based on valid scientific evidence, which is generally derived from well-controlled investigations, usually clinical trials. However, the law provides that other evidence, when appropriate, may be used to establish effectiveness (e.g., well-designed bench and/or animal testing) (FFDCA §513(a)(3)(B) and The Least Burdensome Provisions: Concept and Principles). Regardless of risk, a new device with no substantially

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