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Federal Register / Vol. 86, No. 193 / Friday, October 8, 2021 / Rules and Regulations Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 73 is amended as follows:
PART 73LISTING OF COLOR
ADDITIVES EXEMPT FROM
CERTIFICATION
1. The authority citation for part 73
continues to read as follows:

Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e.
73.2396

Removed
2. Remove 73.2396.

Dated: September 30, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
FR Doc. 202121892 Filed 10721; 8:45 am BILLING CODE 416401P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration 21 CFR Part 878
Docket No. FDA2019N1250

General and Plastic Surgery Devices;
Reclassification of Certain Surgical Staplers AGENCY:

Food and Drug Administration,
HHS.
ACTION:

Final amendment; final order.

The Food and Drug Administration FDA or the Agency is issuing a final order to reclassify surgical staplers for internal use formerly regulated under the classification for manual surgical instrument for general use and assigned the product code GAG from class I general controls into class II
special controls and subject to premarket review. FDA is identifying the special controls for surgical staplers for internal use that the Agency believes are necessary to provide a reasonable assurance of the safety and effectiveness of the device. FDA is issuing this reclassification on its own initiative based on new information. As part of this reclassification, FDA is also amending the existing classification for manual surgical instrument for general use to remove staplers and to create a separate classification regulation for surgical staplers that distinguishes between surgical staplers for internal use and external use.
DATES: This order is effective October 8, 2021.

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SUMMARY:

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FOR FURTHER INFORMATION CONTACT:

George Gibeily, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4660, Silver Spring, MD 20993, 3017960276, george.gibeily@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background The Federal Food, Drug, and Cosmetic Act FD&C Act, as amended, establishes a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C
Act 21 U.S.C. 360c established three categories classes of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I general controls, class II special controls, and class III premarket approval.
Under section 513d1 of the FD&C
Act, devices that were in commercial distribution before the enactment of the 1976 amendments Medical Device Amendments of 1976, Pub. L. 94295, May 28, 1976 generally referred to as preamendments devices, are classified after FDA has: 1 Received a recommendation from a device classification panel an FDA advisory committee; 2 published the Panels recommendation for comment, along with a proposed regulation classifying the device; and 3 published a final regulation classifying the device. FDA
has classified most preamendments devices under these procedures.
Devices that were not in commercial distribution before May 28, 1976
generally referred to as postamendments devices, are automatically classified by section 513f1 of the FD&C Act into class III
without any FDA rulemaking process.
Those devices remain in class III and require premarket approval, unless, and until: 1 FDA reclassifies the device into class I or II or 2 FDA issues an order finding the device to be substantially equivalent, in accordance with section 513i of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to previously marketed devices by means of premarket notification procedures in section 510k of the FD&C Act and part 807, subpart E of the regulations 21
CFR part 807.
On July 9, 2012, Congress enacted the Food and Drug Administration Safety and Innovation Act FDASIA Pub. L.
112144. Section 608a of FDASIA
amended section 513e of the FD&C
Act, changing the process for
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reclassifying a device from rulemaking to an administrative order. Section 513e1Ai of the FD&C Act sets forth the process for issuing such a final order. Specifically, prior to the issuance of an administrative order reclassifying a device, the following must occur: 1
Publication of a proposed reclassification order in the Federal Register, 2 a meeting of a device classification panel described in section 513b of the FD&C Act, and 3
consideration of comments to a public docket. The proposed reclassification order must set forth the proposed reclassification and a substantive summary of the valid scientific evidence concerning the proposed reclassification, including the public health benefits of the use of the device, and the nature and incidence if known of the risks of the device.
Section 513e1Ai provides that FDA may, by administrative order, reclassify a device based on new information. FDA can initiate a reclassification under section 513e or an interested person may petition FDA.
The term new information, as used in section 513e of the FD&C Act, includes information developed as a result of a reevaluation of the data before the Agency when the device was originally classified, as well as information not presented, not available, or not developed at that time See, e.g., Holland-Rantos v. U.S. Dept of Health, Educ. & Welfare, 587 F.2d 1173, 1174
n.1 D.C. Cir. 1978; Upjohn Co. v.
Finch, 422 F.2d 944 6th Cir. 1970; Bell v. Goddard, 366 F.2d 177 7th Cir.
1966.
Reevaluation of the data previously before the Agency is an appropriate basis for subsequent regulatory action where the reevaluation is made in light of newly available regulatory authority see Bell, 366 F.2d at 181 or in light of changes in medical science see Upjohn, 422 F.2d at 951. Whether data before the Agency are old or new, the new information to support reclassification under section 513e of the FD&C Act must be valid scientific evidence, as defined in section 513a3 of the FD&C Act and 21 CFR
860.7c2 See, e.g., Gen. Med. Co. v.
FDA, 770 F.2d 214 D.C. Cir. 1985;
Contact Lens Mfrs. Assn v. FDA, 766
F.2d 592 D.C. Cir. 1985, cert. denied, 474 U.S. 1062 1986.
FDA relies upon valid scientific evidence in the classification process to determine the level of regulation for devices. To be considered in the reclassification process, the valid scientific evidence upon which the Agency relies must be publicly available. Publicly available information
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