Quiero saber acerca de...

Federal Register / Vol. 86, No. 190 / Tuesday, October 5, 2021 / Rules and Regulations Generic type of device means 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.
Implant means a device that is placed into a surgically or naturally formed cavity of the human body. A device is regarded as an implant for the purpose of this part only if it is intended to remain implanted continuously for a period of 30 days or more, unless the Commissioner determines otherwise to protect human health.
Life-supporting or life-sustaining device means a device that is essential to, or that yields information that is essential to, the restoration or continuation of a bodily function important to the continuation of human life.
Petition means a submission seeking reclassification of a device in accordance with 860.123.
Special controls mean the controls necessary to provide reasonable assurance of safety and effectiveness for a generic type of device that is class II.
Special controls include performance standards, performance testing, postmarket surveillance, patient registries, development and dissemination of guidelines including guidelines for the submission of clinical data in premarket notification submissions in accordance with section 510k of the Federal Food, Drug, and Cosmetic Act, recommendations, and other appropriate actions, as the Commissioner deems necessary to provide such assurance.
5. Amend 860.5 by adding paragraph g to read as follows:
860.5 Confidentiality and use of data and information submitted in connection with classification and reclassification.

lotter on DSK11XQN23PROD with RULES1

g Confidentiality of data and information in a De Novo file is as follows:
1 A De Novo file includes all data and information from the requester submitted with or incorporated by reference in the De Novo request, any De Novo supplement, or any other related submission relevant to the administrative file, as defined in 10.3a of this chapter. Any record in the De Novo file will be available for public disclosure in accordance with the provisions of this section and part 20 of this chapter.
2 The existence of a De Novo file may not be disclosed by FDA before an
VerDate Sep<11>2014

17:01 Oct 04, 2021

Jkt 256001

order granting the De Novo request is issued unless it previously has been publicly disclosed or acknowledged by the De Novo requester.
3 Before an order granting the De Novo request is issued, data or information contained in the De Novo file is not available for public disclosure, except to the extent the existence of the De Novo file is disclosable under paragraph g2 of this section and such data or information has been publicly disclosed or acknowledged by the De Novo requester.
4 After FDA issues an order granting a De Novo request, the data and information in the De Novo file that are not exempt from release under the Freedom of Information Act, 5 U.S.C.
552, are immediately available for public disclosure.
6. Add subpart D, consisting of 860.200 through 860.260, to read as follows:
Subpart DDe Novo Classification Sec.
860.200 Purpose and applicability.
860.210 De Novo request format.
860.220 De Novo request content.
860.230 Accepting a De Novo request.
860.240 Procedures for review of a De Novo request.
860.250 Withdrawal of a De Novo request.
860.260 Granting or declining a De Novo request.

Subpart DDe Novo Classification 860.200

Purpose and applicability.

a The purpose of this part is to establish an efficient, transparent, and thorough process to facilitate De Novo classification into class I or class II for devices for which there is no legally marketed device on which to base a review of substantial equivalence and which meet the definition of class I or class II as described in section 513a1
of the Federal Food, Drug, and Cosmetic Act and 860.3.
b De Novo requests can be submitted for a single device type:
1 After receiving a not substantially equivalent determination in response to a premarket notification 510k, or 2 If a person determines there is no legally marketed device upon which to base a determination of substantial equivalence.
860.210

De Novo request format.

a Each De Novo request or information related to a De Novo request pursuant to this part must be formatted in accordance with this section. Each De Novo request must be provided as a single version in electronic format.
These materials must:

PO 00000

Frm 00047

Fmt 4700

Sfmt 4700

54847

1i For devices regulated by the Center for Devices and Radiological Health, be sent to the current address displayed on the website https
www.fda.gov/cdrhsubmissionaddress.
ii For devices regulated by the Center for Biologics Evaluation and Research, be sent to the current address displayed on the website https
www.fda.gov/about-fda/centerbiologics-evaluation-and-research-cber/
regulatory-submissions-electronic-andpaper.
2 Be signed by the requester or an authorized representative.
3 Be designated De Novo Request in the cover letter.
4 Have all content used to support the request written in, or translated into, English.
860.220

De Novo request content.

a Unless the requester justifies an omission in accordance with paragraph c of this section, a De Novo request must include:
1 Table of contents. A table of contents that specifies the volume if the De Novo request contains more than one volume and page number for each item.
2 Administrative information. The name, address, phone, and email address of the requester and U.S.
representative, if applicable. The establishment registration number, if applicable, of the owner or operator submitting the De Novo request.
3 Regulatory history. Identify any prior submissions to FDA for the device, including, but not limited to, any premarket notifications 510ks submitted under part 807 of this chapter; applications for premarket approval PMAs submitted under part 814 of this chapter; applications for humanitarian device exemption HDE
submitted under part 814 of this chapter; applications for investigational device exemption IDEs submitted under part 812 of this chapter; requests for designation RFD under 3.7 of this chapter; requests for information under section 513g of the Federal Food, Drug, and Cosmetic Act; applications for emergency use authorization EUA
under section 564 of the Federal Food, Drug, and Cosmetic Act; presubmissions, or previously submitted De Novo requests; or state that there have been no prior submissions.
4 Device name. The generic name of the device as well as any proprietary name or trade name.
5 Indications for use. A general description of the disease or condition the device is intended to diagnose, treat, prevent, cure or mitigate, or affect the structure or function of the body, including a description of the patient
E:FRFM05OCR1.SGM

05OCR1