Drug Regulators, FDA, Publishes Draft Guidance for Industry and FDA staff, on Procedures for Section 513(g) Requests for Information Under The Federal Food, Drug and Cosmetic Act.
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The purpose of this guidance is to establish procedures for submitting, reviewing and responding to requests for information respecting the class in which a device has been classified or the requirements applicable to a device under the Federal Food, Drug, and Cosmetic Act (the Act) that are submitted in accordance with section 513(g) of the Act, 21 U.S.C. 360c(g).
Section 513(a) of the Act (21 U.S.C. 360c(a)) establishes three classes of devices based on the regulatory controls needed to provide reasonable assurance of their safety and effectiveness: class I (general controls), class II (special controls), and class III (premarket approval). Under section 513(f) of the Act (21 U.S.C. 360c(f)), post-amendments devices (devices that were not in commercial distribution before May 28, 1976, the date the Medical Device Amendments were enacted) are classified in Class III. However, FDA may reclassify a post-amendments device (as Class I or II) or determine that such a device is “substantially equivalent” (SE)1 to either another post-amendments device that has been classified into Class I or II or to a preamendments device for which premarket approval is not required. Thus, a post-amendments device may be subject to regulation as a Class I or II device in certain circumstances, including when:
• the device is within a type of device that has been classified into class I or II and FDA has found the device to be SE to a device within such type;
• the device is within a type of pre-amendments device which is to be classified under section 513(b) of the Act (21 U.S.C. 360c(b)) and FDA has found the device to be SE to a device within such type (an unclassified device type); or
• FDA has classified or reclassified the device type in class I or II in accordance with sections 513(f)(2) or 513(f)(3) of the Act (21 U.S.C. 360c(f)(2), (3)).
Pursuant to section 513(d) of the Act (21 U.S.C. 360c(d)), FDA promulgates classification regulations classifying devices by generic type. A “generic type of device” is “a grouping of devices that do not differ significantly in purpose, design, materials, energy source, function, or any other feature related to safety and effectiveness, and for which similar regulatory controls are sufficient to provide reasonable assurance of safety and effectiveness.” 21 CFR 860.3(i). FDA has issued regulations classifying the vast majority of pre-amendments devices (devices that were in commercial distribution before May 28, 1976) by generic type of device. See 21 CFR 860.84. Each classification regulation, located at 21 CFR parts 862-892, indicates in which class (I, II, or III) FDA has classified the device type. While the great majority of device classifications codified in 21 CFR parts 862-892 are of pre-amendments devices, some of these classifications are of post-amendments devices.
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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