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1 1 (September 29, 2021)

handle is hein.crs/govegmb0001 and id is 1 raw text is: Congressional Research Se Infrmring the legislitive debate since 191 Updated September 29, 2021 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 Section 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 therapeutic biologics; 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. Prenarket Requirements 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 a new drug application (NDA) demonstrating that the drug is safe and effective for its proposed use. The law requires, among other things, substantial evidence of effectiveness, and the agency has some discretion to determine what evidence is necessary for NDA approval. During review, FDA officials evaluate the drug's safety and effectiveness for the intended use (derived from clinical trials); adequacy of manufacturing methods to ensure the drug's identity, strength, quality, and purity; and accuracy of the proposed labeling. Sponsors must comply with current good manufacturing practice (CGMP) regulations, which provide minimum requirements for the methods, facilities, and controls used in manufacturing a drug. For drugs 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. 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 biologic and the facilities and processes for manufacturing the product are safe, pure, and potent (i.e., effective). The requirements and review pathway for BLAs are generally similar to that for NDAs, and biologics are subject to certain FFDCA provisions (e.g., REMS). 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, and listing and compliance with CGMPs as set forth in FDA's quality system regulations (QSRs). Almost all Class I devices are exempt from the 510(k) premarket notification requirement. In addition to general controls, Class II devices must meet special controls, which are usually device-specific. Premarket special controls include performance standards and premarket data requirements. Almost all Class II devices require 510(k) clearance, demonstrating that a device is substantially equivalent to a predicate device, prior to marketing. A 510(k) application typically does not require submission of clinical data. In November 2018, FDA announced changes to modernize the 510(k) clearance pathway, including sunsetting certain older predicate devices. Class III devices are subject to premarket approval application (PMA) requirements, with some exceptions, in addition to having to meet 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). Effectiveness must be based on well-controlled investigations, which generally means clinical trial data. 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 of the FDA Modernization Act of 1997). Regardless of risk, a new device with no substantially equivalent predicate device is automatically designated Class III unless the manufacturer submits a reclassification request or petition. The de novo pathway allows for certain lower-risk, novel devices to be reclassified from Class III to Class I or II;

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