Code of Federal Regulations Title 21 Section 807.65 Subpart D. Going to the proper CFR search page: ... -CITE- 21 CFR Sec. Sec. (3) The foreign establishment or the United States agent shall report changes in the United States agent's name, address, or phone number to FDA within 10-business days of the change. Meet our MDR team and get free educational resources on the MDR. 807.87 Information required in a premarket notification submission. gtag('js', new Date()); '; UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality. § 807.25 - Information required for device establishment registration and device listing. Source: 42 FR 42526, Aug. 23, 1977, unless otherwise noted. [42 FR 42526, Aug. 23, 1977, as amended at 43 FR 37997, Aug. 25, 1978; 57 FR 18066, Apr. 807.85 Exemption from premarket notification. All establishment registrations must be submitted electronically unless a waiver has been granted by FDA. (g) Initial importer means any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer or user, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package. (c) For each individual or organization identified by the foreign establishment under paragraphs (a) and (b) of this section, the foreign establishment must submit to FDA electronically the current FDA premarket submission number and any other identifying information that is known to the establishment for each device being imported or offered for import by the named individuals or organizations. (e) Pharmacies, surgical supply outlets, or other similar retail establishments making final delivery or sale to the ultimate user. 21 cfr, pt 807 title 21--food and drugs chapter i--food and drug administration, department of health and human services subchapter h--medical devices part 807--establishment registration and device listing for manufacturers and initial importers of devices subpart a--general provisions sec. Times for establishment registration and device listing. (a) A manufacturer of raw materials or components to be used in the manufacture or assembly of a device who would otherwise not be required to register under the provisions of this part. A request for additional information will advise the owner or operator that there is insufficient information contained in the original premarket notification submission for the Commissioner to make this determination and that the owner or operator may either submit the requested data or a new premarket notification containing the requested information at least 90 days before the owner or operator intends to market the device, or submit a premarket approval application in accordance with section 515 of the act. blood filters, hemodialysis tubing, or devices which of necessity must be further processed by a licensed practitioner or other qualified person to meet the needs of a particular patient, e.g., a manufacturer of ophthalmic lens blanks. (3) All inquiries regarding a premarket notification submission should be in writing and sent to one of the addresses above. 807.92 Content and format of a 510(k) summary. gtag('config', 'UA-53164437-4'); PART 807 - ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES Authority:21 U.S.C. - 21 CFR 11, 50, 54, 56, 807, 812, 814, 820, 510K & PMA - Medical Device Combination - 21 CFR 11, 50, 54, 56, 312, 314, ICH E2A, E6(R2) - Good Clinical Practice Handbook - GMP International Pharmaceutical Master Reference Guide - Over 900 pages of Guidance and Regulations [Title 21, Volume 8]
(d) Owners and operators of establishments or persons engaged in the recovery, screening, testing, processing, storage, or distribution of human cells, tissues, and cellular and tissue-based products, as defined in 1271.3(d) of this chapter, that are regulated under the Federal Food, Drug, and Cosmetic Act must register and list those human cells, tissues, and cellular and tissue-based products with the Center for Biologics Evaluation and Research on Form FDA 3356 following the procedures set out in subpart B of part 1271 of this chapter, instead of the procedures for registration and listing contained in this part, except that the additional listing information requirements of 807.26 remain applicable. (2) If introducing into commercial distribution a non-exempt device with an FDA premarket submission number that is not currently listed by the owner or operator. Electronic submissions of registration and listing information must comply with part 11 of this chapter, except for the requirements in 11.10(b), (c), and (e), and the corresponding requirements in 11.30 of this chapter. View All. (a) An owner or operator of an establishment not exempt under section 510(g) of the Federal Food, Drug, and Cosmetic Act or subpart D of this part who is engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of a device intended for human use shall register and submit listing information for those devices in commercial distribution, except that registration and listing information may be submitted by the parent, subsidiary, or affiliate company for all the domestic or foreign establishments under the control of one of these organizations when operations are conducted at more than one establishment and there exists joint ownership and control among all the establishments. (i) A financial certification or disclosure statement or both, as required by part 54 of this chapter. 28, 1992; 59 FR 64295, Dec. 14, 1994; 63 FR 5253, Feb. 2, 1998]. (b) Each foreign establishment required to register under paragraph (a) of this section shall submit the name, address, and phone number of its United States agent as part of its initial and updated registration information in accordance with subpart B of this part. (d) Licensed practitioners, including physicians, dentists, and optometrists, who manufacture or otherwise alter devices solely for use in their practice. AE 2.106/3:21/ Contained Within. Misbranding by reference to establishment registration or to registration number. If a device requires the submission of premarket notification, it cannot be commercially distributed in the United States until it receives an authorization from FDA. [Code of Federal Regulations] [Title 21, Volume 8] [Revised as of April 1, 2014] [CITE: 21CFR803] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H--MEDICAL DEVICES PART 803 MEDICAL DEVICE REPORTING Subpart A--General Provisions § 803.1 - What does this part cover? If the establishment has already registered in the past, the letter should also include the owner or operator number, registration number, and any listing numbers previously assigned by FDA for devices manufactured at that establishment. (5) For a particular device, a statement of the basis upon which the registrant has determined the device is not a restricted device. 21 CFR 807 - Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices. This exemption also applies to a pharmacy or other similar retail establishment that purchases a device for subsequent distribution under its own name, e.g., a properly labeled health aid such as an elastic bandage or crutch, indicating "distributed by" or "manufactured for" followed by the name of the pharmacy. Both numbers will be sent to the official correspondent by email, or by postal mail if the owner or operator has been granted a waiver from the requirement to file registration and listing information electronically. This discussion shall include, where applicable, a description of the subjects upon whom the device was tested, a discussion of the safety or effectiveness data obtained from the testing, with specific reference to adverse effects and complications, and any other information from the clinical testing relevant to a determination of substantial equivalence; and. (d) Any other information reasonably deemed necessary by the agency. [Revised as of April 1, 2014]
L. 91–513 consisted of sections 701 to 709. FDA will accept summaries as well as amendments thereto until such time as FDA issues a determination of substantial equivalence. The original Part G of title II of Pub. 807.20 Who must register and submit a device list? Each foreign establishment shall designate only one United States agent and may designate the United States agent to act as its official correspondent. (3) The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified in paragraph (a)(3) of this section. (a) Actmeans the Federal Food, Drug, and Cosmetic Act. Recommendations for preparing for Eudamed compliance ahead of MDR and IVDR dates of application, Resources and tools tailored to medical device professionals. (r) Class III summary means a summary of the types of safety and effectiveness problems associated with the type of device being compared and a citation to the information upon which the summary is based. The requirements for CGTP are found in subparts C and D of 21 CFR 1271 that govern the methods used in, and the facilities and controls used for, the manufacture of HCT/Ps. (b) Commercial distribution means any distribution of a device intended for human use which is held or offered for sale but does not include the following: (1) Internal or interplant transfer of a device between establishments within the same parent, subsidiary, and/or affiliate company; (2) Any distribution of a device intended for human use which has in effect an approved exemption for investigational use under section 520(g) of the act and part 812 of this chapter; (3) Any distribution of a device, before the effective date of part 812 of this chapter, that was not introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976, and that is classified into class III under section 513(f) of the act:Provided, That the device is intended solely for investigational use, and under section 501(f)(2)(A) of the act the device is not required to have an approved premarket approval application as provided in section 515 of the act; or. [42 FR 42526, Aug. 23, 1977, as amended at 72 FR 73601, Dec. 28, 2007]. [57 FR 58403, Dec. 10, 1992, as amended at 63 FR 5253, Feb. 2, 1998]. Misbranding by reference to premarket notification. (2) The product code for each device that is exempt from premarket notification and approval or which was in commercial distribution prior to May 28, 1976. 807.40 Establishment registration and device listing for foreign establishments importing or offering for import devices into the United States. (a) Establishment registration and device listing information is available for public inspection in accordance with section 510(f) of the Federal Food, Drug, and Cosmetic Act and will be posted on the FDA Web site, with the exception of the information identified in paragraph (b) of this section. 331(q); and. (1) The United States agent shall reside or maintain a place of business in the United States. (c) Failure to submit required information. Source: 42 FR 42526, Aug. 23, 1977, unless otherwise noted. Each owner or operator shall also provide FDA with the name of a contact person at the owner or operator's offices who will be responsible for identifying the official correspondent for each establishment. Sec. (y) Person who imports or offers for import means, for purposes of this part, an agent, broker, or other entity, other than a carrier, that the foreign establishment uses to facilitate the import of its device into the United States. (3) For a device that is neither a restricted device, nor subject to section 514 of 515 of the act, the label and package insert for the device and a representative sampling of any other labeling for the device. Content and format of a 510(k) statement. 807.92 Content and format of a 510(k) summary. (f) The designation of an official correspondent does not in any manner affect the liability of the owner or operator of the establishment or any other individual under section 301(p) or any other provision of the Federal Food, Drug, and Cosmetic Act.