Document ID: FDA-2017-N-0011-0003
Agency: fda
Document Type: Rule
Title: Humanitarian Use Devices; 21st Century Cures Act; Technical Amendment
Posted Date: 2017-06-07T04:00Z

[Federal Register Volume 82, Number 108 (Wednesday, June 7, 2017)]
[Rules and Regulations]
[Pages 26348-26349]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-11816]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 814

[Docket No. FDA-2017-N-0011]

Humanitarian Use Devices; 21st Century Cures Act; Technical 
Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending regulations 
to reflect changes recently enacted into law by the 21st Century Cures 
Act. Specifically, certain requirements related to humanitarian device 
exemptions (HDEs) and institutional review boards (IRBs) for devices 
have changed. This action is being taken to align the regulations with 
the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended.

DATES: This rule is effective June 7, 2017.

FOR FURTHER INFORMATION CONTACT: Ian Ostermiller, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5515, Silver Spring, MD 20993-0002, 301 
796-5678.

SUPPLEMENTARY INFORMATION: On December 13, 2016, the 21st Century Cures 
Act (Pub. L. 114-255) was signed into law, amending certain provisions 
of the FD&C Act. FDA is updating regulations to reflect some of those

[[Page 26349]]

changes that are now in effect. Specifically, section 3052 of the 21st 
Century Cures Act amended section 520(m) of the FD&C Act to allow for 
HDE approval for devices that, among other things, treat or diagnose a 
disease or condition that affects ``not more than 8,000'' individuals 
in the United States; this threshold had been ``fewer than 4,000'' 
individuals in the United States (amending 21 U.S.C. 360j(m), passim). 
This final rule amends part 814 (21 CFR part 814) in several places to 
accurately reflect the threshold recently enacted into law.
    In addition, section 3056 of the 21st Century Cures Act amended 
section 520 of the FD&C Act to remove the requirement for institutional 
review committees, i.e., IRBs, for devices to be ``local'', (amending 
21 U.S.C. 360j, passim). This final rule amends 21 CFR 814.124(a), 
``IRB approval'', to remove the term ``local'' and related language in 
order to accurately reflect the requirements recently enacted into law.
    FDA finds good cause for issuing this amendment as a final rule 
without notice and comment because this amendment only updates the 
implementing regulation to restate the statute in light of amendments 
recently enacted into law (see 5 U.S.C. 553(b)(B), relating to notice 
and comment procedures): ``[W]hen regulations merely restate the 
statute they implement, notice-and-comment procedures are 
unnecessary''. Gray Panthers Advocacy Committee v. Sullivan, 936 F.2d 
1284, 1291 (D.C. Cir. 1991); see also Komjathy v. Nat. Trans. Safety 
Bd., 832 F.2d 1294, 1296 (D.C. Cir. 1987) (when a rule ``does no more 
than repeat, virtually verbatim, the statutory grant of authority'', 
notice-and-comment procedures are not required). Therefore, we are 
issuing these amendments as a final rule, and publication of this 
document constitutes final action on this change under the 
Administrative Procedure Act (APA) (5 U.S.C. 553).
    In addition, FDA finds good cause for these amendments to become 
effective on the date of publication of this action. The APA allows an 
effective date less than 30 days after publication as ``provided by the 
agency for good cause found and published with the rule'' (5 U.S.C. 
553(d)(3)). A delayed effective date is unnecessary in this case 
because the new requirements are already effective as a matter of law. 
Furthermore, this rule does not establish additional regulatory 
obligations or impose additional burden on regulated entities. As a 
result, affected parties do not need time to prepare before the rule 
takes effect. Therefore, FDA finds good cause for these amendments to 
become effective on the date of publication of this action.

List of Subjects in 21 CFR Part 814

    Administrative practice and procedure, Confidential business 
information, Medical devices, Medical research, Reporting and 
recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
814 is amended as follows:

PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES

    1. The authority citation for part 814 continues to read as 
follows:

    Authority:  21 U.S.C. 351, 352, 353, 360, 360c-360j, 371, 372, 
373, 374, 375, 379, 379e, 381.

Sec.  814.3  [Amended]

0
2. Amend Sec.  814.3(n) by removing the words ``fewer than 4,000'' and 
adding in their place the words ``not more than 8,000''.

Sec.  814.100  [Amended]

0
3. Amend Sec.  814.100(b) introductory text by removing the words 
``fewer than 4,000'' and adding in their place the words ``not more 
than 8,000''.

Sec.  814.102  [Amended]

0
4. Amend Sec.  814.102 as follows:
0
a. In paragraph (a)(5), remove the words ``fewer than 4,000'' in both 
occurrences and add in their places the words ``not more than 8,000'' 
for both occurrences;
0
b. In paragraph (b)(3)(i), remove the words ``fewer than 4,000'' and 
add in their place the words ``not more than 8,000''; and
0
c. In paragraph (b)(3)(ii), remove the words ``4,000 or more'' and add 
in their place the words ``more than 8,000''.

0
5. In Sec.  814.124, revise paragraph (a) to read as follows:

Sec.  814.124  Institutional Review Board requirements.

    (a) IRB approval. The HDE holder is responsible for ensuring that a 
HUD approved under this subpart is administered only in facilities 
having oversight by an Institutional Review Board (IRB) constituted and 
acting pursuant to part 56 of this chapter, including continuing review 
of use of the device. In addition, a HUD may be administered only if 
such use has been approved by an IRB. If, however, a physician in an 
emergency situation determines that approval from an IRB cannot be 
obtained in time to prevent serious harm or death to a patient, a HUD 
may be administered without prior approval by an IRB. In such an 
emergency situation, the physician shall, within 5 days after the use 
of the device, provide written notification to the chairman of the IRB 
of such use. Such written notification shall include the identification 
of the patient involved, the date on which the device was used, and the 
reason for the use.
* * * * *

Sec.  814.126   [Amended]

0
6. Amend Sec.  814.126(b)(1)(iii) by removing the number ``4,000'' and 
adding in its place the number ``8,000''.

    Dated: June 1, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-11816 Filed 6-6-17; 8:45 am]
 BILLING CODE 4164-01-P