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1 1 (January 28, 2019)

handle is hein.crs/govydl0001 and id is 1 raw text is: Cogesoa Reerh evc January 28, 2019 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 20 1(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. Premarket 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 prescription 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 prescription 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. The exception to this is certain natural source biologics regulated as drugs under the FFDCA (e.g., insulin). However, this will no longer be the case in March 2020, when applications for biologics approved under the FFDCA will be deemed to be licenses under 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. 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 classified based on the risk posed to the consumer. Class I devices are low-risk (e.g., elastic bandages) and are generally exempt from premarket review. Class II and Class III devices are moderate-risk (e.g., powered wheelchairs) and high-risk (e.g., heart valves), respectively, and usually require premarket review. Unless specifically excluded by regulation, all devices must meet general controls, which include premarket and postmarket requirements; for example, registration, labeling, and compliance with CGMPs as set forth in FDA's quality system regulations (QSRs). As QSRs apply to many different devices, the regulations are broad and flexible. In addition to general controls, Class II devices must meet special controls, which are usually device-specific. Premarket special controls include performance standards and data requirements. Generally, Class II devices require 5 10(k) clearance demonstrating that a device is substantially equivalent to a device already on the market (i.e., a predicate device). A 5 10(k) application typically does not require submission of clinical data. Approximately 82% of total devices authorized for marketing in 2017 were cleared through the 5 10(k) clearance pathway. In November 2018, FDA announced changes to modernize the 5 10(k) clearance pathway, including sunsetting certain older predicate devices. However, the agency may need additional guidance from Congress before proceeding. Generally, Class III devices require a premarket approval application (PMA), with some exceptions. 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 https://crsreports.congressg S

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