Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Rules and Regulations 45725 

17 CFR Part 230 

Reporting and recordkeeping 

requirements, Securities. 

In accordance with the foregoing, title 

17, chapter II of the Code of Federal 

Regulations is amended as follows: 

PART 227—REGULATION 

CROWDFUNDING, GENERAL RULES 

AND REGULATIONS 

■ 1. The authority citation for part 227 

is revised to read as follows: 

Authority: 15 U.S.C. 77d, 77d–1, 77s, 77z– 

3, 78c, 78o, 78q, 78w, 78mm, and Pub. L. 

112–106, secs. 301–305, 126 Stat. 306 (2012). 

■ 2. Amend § 227.202 by adding 

paragraph (c) to read as follows: 

§ 227.202 Ongoing reporting requirements. 

* * * * * 

(c) Temporary relief from certain 

reporting requirements. (1) An issuer 

that is not able to meet a filing deadline 

for any report or form required to be 

filed by this section (Rule 202), Rule 

203(a)(3) (§ 227.203(a)(3)), or Rule 

203(b) (§ 227.203(b)), as applicable: 

(i) During the period from and 

including August 25, 2017 to and 

including October 26, 2017 due to 

Hurricane Harvey and its aftermath 

shall be deemed to have satisfied the 

filing deadline for such report or form 

if the issuer files such report or form 

with the Commission on or before 

October 27, 2017; 

(ii) During the period from and 

including September 6, 2017 to and 

including November 7, 2017 due to 

Hurricane Irma and its aftermath shall 

be deemed to have satisfied the filing 

deadline for such report or form if the 

issuer files such report or form with the 

Commission on or before November 8, 

2017; or 

(ii) During the period from and 

including September 20, 2017 to and 

including November 21, 2017 due to 

Hurricane Maria and its aftermath shall 

be deemed to have satisfied the filing 

deadline for such report or form if the 

issuer files such report or form with the 

Commission on or before November 22, 

2017. 

(2) In any report or form filed 

pursuant to paragraph (c)(1) of this 

section, the issuer must disclose that it 

is relying on this paragraph (c) (Rule 

202(c) of Regulation Crowdfunding) and 

state the reasons why, in good faith, it 

could not file such report or form on a 

timely basis. 

PART 230—GENERAL RULES AND 

REGULATIONS, SECURITIES ACT OF 

1933 

■ 3. The authority citation for part 230 

continues to read in part as follows: 

Authority: 15 U.S.C. 77b, 77b note, 77c, 

77d, 77f, 77g, 77h, 77j, 77r, 77s, 77z–3, 77sss, 

78c, 78d, 78j, 78l, 78m, 78n, 78o, 78o–7 note, 

78t, 78w, 78ll(d), 78mm, 80a–8, 80a–24, 80a– 

28, 80a–29, 80a–30, and 80a–37, and Pub. L. 

112–106, sec. 201(a), sec. 401, 126 Stat. 313 

(2012), unless otherwise noted. 

* * * * * 

■ 4. Amend § 230.257 by adding 

paragraph (f) to read as follows: 

§ 230.257 Periodic and current reporting; 

exit report. 

* * * * * 

(f) Temporary relief from ongoing 

reporting requirements. (1) An issuer 

that is not able to meet a filing deadline 

for any report or form required to be 

filed by Rule 252(f)(2)(i) 

(§ 230.252(f)(2)(i)) or this section (Rule 

257), as applicable: 

(i) During the period from and 

including August 25, 2017 to and 

including October 26, 2017 due to 

Hurricane Harvey and its aftermath 

shall be deemed to have satisfied the 

filing deadline for such report or form 

if the issuer files such report or form 

with the Commission on or before 

October 27, 2017; 

(ii) During the period from and 

including September 6, 2017 to and 

including November 7, 2017 due to 

Hurricane Irma and its aftermath shall 

be deemed to have satisfied the filing 

deadline for such report or form if the 

issuer files such report or form with the 

Commission on or before November 8, 

2017; or 

(ii) During the period from and 

including September 20, 2017 to and 

including November 21, 2017 due to 

Hurricane Maria and its aftermath shall 

be deemed to have satisfied the filing 

deadline for such report or form if the 

issuer files such report or form with the 

Commission on or before November 22, 

2017. 

(2) In any report or form filed 

pursuant to paragraph (f)(1) of this 

section, the issuer must disclose that it 

is relying on this paragraph (f) (Rule 

257(f) of Regulation A) and state the 

reasons why, in good faith, it could not 

file such report or form on a timely 

basis. 

By the Commission. 

Dated: September 27, 2017. 

Brent J. Fields, 

Secretary. 

[FR Doc. 2017–21094 Filed 9–28–17; 4:15 pm] 

BILLING CODE 8011–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 876 

[Docket No. FDA–2017–N–5153] 

Medical Devices; GastroenterologyUrology Devices; Classification of the 

High Intensity Ultrasound System for 

Prostate Tissue Ablation 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

classifying the high intensity ultrasound 

system for prostate tissue ablation into 

class II (special controls). The special 

controls that apply to the device type 

are identified in this order and will be 

part of the codified language for the 

high intensity ultrasound system for 

prostate tissue ablation’s classification. 

We are taking this action because we 

have determined that classifying the 

device into class II (special controls) 

will provide a reasonable assurance of 

safety and effectiveness of the device. 

We believe this action will also enhance 

patients’ access to beneficial innovative 

devices, in part by reducing regulatory 

burdens. 

DATES: This order is effective October 2, 

2017. The classification was applicable 

on October 9, 2015. 

FOR FURTHER INFORMATION CONTACT: John 

Baxley, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. G210, Silver Spring, 

MD 20993–0002, 301–796–6549, 

john.baxley@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

high intensity ultrasound system for 

prostate tissue ablation as class II 

(special controls), which we have 

determined will provide a reasonable 

assurance of safety and effectiveness. In 

addition, we believe this action will 

enhance patients’ access to beneficial 

innovation, in part by reducing 

regulatory burdens by placing the 

device into a lower device class than the 

automatic class III assignment. 

The automatic assignment of class III 

occurs by operation of law and without 

any action by FDA, regardless of the 

level of risk posed by the new device. 

Any device that was not in commercial 

distribution before May 28, 1976, is 

automatically classified as, and remains 


jstallworth on DSKBBY8HB2PROD with RULES
45726 Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Rules and Regulations 

within, class III and requires premarket 

approval unless and until FDA takes an 

action to classify or reclassify the device 

(see 21 U.S.C. 360c(f)(1)). We refer to 

these devices as ‘‘postamendments 

devices’’ because they were not in 

commercial distribution prior to the 

date of enactment of the Medical Device 

Amendments of 1976, which amended 

the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act). 

FDA may take a variety of actions in 

appropriate circumstances to classify or 

reclassify a device into class I or II. We 

may issue an order finding a new device 

to be substantially equivalent under 

section 513(i) of the FD&C Act to a 

predicate device that does not require 

premarket approval (see 21 U.S.C. 

360c(i)). We determine whether a new 

device is substantially equivalent to a 

predicate by means of the procedures 

for premarket notification under section 

510(k) of the FD&C Act and part 807 (21 

U.S.C. 360(k) and 21 CFR part 807, 

respectively). 

FDA may also classify a device 

through ‘‘De Novo’’ classification, a 

common name for the process 

authorized under section 513(f)(2) of the 

FD&C Act. Section 207 of the Food and 

Drug Administration Modernization Act 

of 1997 established the first procedure 

for De Novo classification 

(Pub. L. 105–115). Section 607 of the 

Food and Drug Administration Safety 

and Innovation Act modified the De 

Novo application process by adding a 

second procedure (Pub. L. 112–144). A 

device sponsor may utilize either 

procedure for De Novo classification. 

Under the first procedure, the person 

submits a 510(k) for a device that has 

not previously been classified. After 

receiving an order from FDA classifying 

the device into class III under section 

513(f)(1) of the FD&C Act, the person 

then requests a classification under 

section 513(f)(2). 

Under the second procedure, rather 

than first submitting a 510(k) and then 

a request for classification, if the person 

determines that there is no legally 

marketed device upon which to base a 

determination of substantial 

equivalence, that person requests a 

classification under section 513(f)(2) of 

the FD&C Act. 

Under either procedure for De Novo 

classification, FDA shall classify the 

device by written order within 120 days. 

The classification will be according to 

the criteria under section 513(a)(1) of 

the FD&C Act. Although the device was 

automatically within class III, the De 

Novo classification is considered to be 

the initial classification of the device. 

We believe this De Novo classification 

will enhance patients’ access to 

beneficial innovation, in part by 

reducing regulatory burdens. When FDA 

classifies a device into class I or II via 

the De Novo process, the device can 

serve as a predicate for future devices of 

that type, including for 510(k)s (see 21 

U.S.C. 360c(f)(2)(B)(i)). As a result, other 

device sponsors do not have to submit 

a De Novo request or premarket 

approval application in order to market 

a substantially equivalent device (see 21 

U.S.C. 360c(i), defining ‘‘substantial 

equivalence’’). Instead, sponsors can use 

the less burdensome 510(k) process, 

when necessary, to market their device. 

II. De Novo Classification 

On March 23, 2015, SonaCare 

Medical, LLC submitted a request for De 

Novo classification of the 

Sonablate® 450. FDA reviewed the 

request in order to classify the device 

under the criteria for classification set 

forth in section 513(a)(1) of the FD&C 

Act. We classify devices into class II if 

general controls by themselves are 

insufficient to provide reasonable 

assurance of safety and effectiveness, 

but there is sufficient information to 

establish special controls that, in 

combination with the general controls, 

provide reasonable assurance of the 

safety and effectiveness of the device for 

its intended use (see 21 U.S.C. 

360c(a)(1)(B)). After review of the 

information submitted in the request, 

we determined that the device can be 

classified into class II with the 

establishment of special controls. FDA 

has determined that these special 

controls, in addition to general controls, 

will provide reasonable assurance of the 

safety and effectiveness of the device. 

Therefore, on October 9, 2015, FDA 

issued an order to the requestor 

classifying the device into class II. FDA 

is codifying the classification of the 

device by adding 21 CFR 876.4340. We 

have named the generic type of device 

high intensity ultrasound system for 

prostate tissue ablation, and it is 

identified as a prescription device that 

transmits high intensity therapeutic 

ultrasound energy into the prostate to 

thermally ablate a defined, targeted 

volume of tissue, performed under 

imaging guidance. This classification 

does not include devices that are 

intended for the treatment of any 

specific prostate disease and does not 

include devices that are intended to 

ablate non-prostatic tissues/organs. 

FDA has identified the following risks 

to health associated specifically with 

this type of device and the measures 

required to mitigate these risks in 

table 1. 

TABLE 1—HIGH INTENSITY ULTRASOUND SYSTEM FOR PROSTATE TISSUE ABLATION RISKS AND MITIGATION MEASURES

Identified risks Mitigation measures 

Thermal injury from high intensity ultrasound exposure to non-target tissue: 

• Erectile dysfunction 

• Urinary incontinence 

• Rectal fistula 

• Osteomyelitis pubis 

Non-clinical performance testing; Software verification, validation, and 

hazard analysis; In vivo testing; Clinical testing; Labeling; and Physician training. 

Thermal injury from high intensity ultrasound exposure to target tissue: 

• Urethral stricture 

• Bladder neck contracture 

• Urinary retention 

• Tissue debris/obstruction 

• Voiding dysfunction 

• Dysuria 

• Hematuria 

• Ejaculation disorder 

Clinical testing, Labeling, and Physician training. 

Mechanical injury from unintentional movement of ultrasound components: 

• Patient rectal injury 

• Operator hand injury 

Software verification, validation, and hazard analysis; Clinical testing; 

Labeling; and Physician training. 


jstallworth on DSKBBY8HB2PROD with RULES
Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Rules and Regulations 45727 

TABLE 1—HIGH INTENSITY ULTRASOUND SYSTEM FOR PROSTATE TISSUE ABLATION RISKS AND MITIGATION MEASURES— 

Continued 

Identified risks Mitigation measures 

Infection .................................................................................................... Sterilization validation, Reprocessing validation, Shelf life validation, 

and Labeling. 

Electrical shock/electromagnetic interference .......................................... Electrical safety testing, Electromagnetic compatibility testing, and Labeling. 

Adverse tissue reaction ............................................................................ Biocompatibility testing. 

FDA has determined that special 

controls, in combination with the 

general controls, address these risks to 

health and provide reasonable assurance 

of safety and effectiveness. In order for 

a device to fall within this classification, 

and thus avoid automatic classification 

in class III, it would have to comply 

with the special controls named in this 

final order. The necessary special 

controls appear in the regulation 

codified by this order. This device is 

subject to premarket notification 

requirements under section 510(k). 

At the time of classification, high 

intensity ultrasound systems for 

prostate tissue ablation are for 

prescription use only. Prescription 

devices are exempt from the 

requirement for adequate directions for 

use for the layperson under section 

502(f)(1) of the FD&C Act (21 U.S.C. 

352(f)(1)) and 21 CFR 801.5, as long as 

the conditions of 21 CFR 801.109 are 

met. 

III. Analysis of Environmental Impact 

The Agency has determined under 21 

CFR 25.34(b) that this action is of a type 

that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

IV. Paperwork Reduction Act of 1995 

This final administrative order 

establishes special controls that refer to 

previously approved collections of 

information found in other FDA 

regulations. These collections of 

information are subject to review by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3501–3520). The 

collections of information in part 807, 

subpart E, regarding premarket 

notification submissions have been 

approved under OMB control number 

0910–0120, and the collections of 

information in part 801, regarding 

labeling, have been approved under 

OMB control number 0910–0485. 

List of Subjects in 21 CFR Part 876 

Medical devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 876 is 

amended as follows: 

PART 876—GASTROENTEROLOGY– 

UROLOGY DEVICES 

■ 1. The authority citation for part 876 

continues to read as follows: 

Authority: 21 U.S.C. 351, 360, 360c, 360e, 

360j, 360l, 371. 

■ 2. Add § 876.4340 to subpart E to read 

as follows: 

§ 876.4340 High intensity ultrasound 

system for prostate tissue ablation. 

(a) Identification. A high intensity 

ultrasound system for prostate tissue 

ablation is a prescription device that 

transmits high intensity therapeutic 

ultrasound energy into the prostate to 

thermally ablate a defined, targeted 

volume of tissue, performed under 

imaging guidance. This classification 

does not include devices that are 

intended for the treatment of any 

specific prostate disease and does not 

include devices that are intended to 

ablate non-prostatic tissues/organs. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) Non-clinical performance data 

must demonstrate that the device 

performs as intended under anticipated 

conditions of use. The following 

performance characteristics must be 

tested: 

(i) Characterization of acoustic 

pressure and power output at clinically 

relevant levels; 

(ii) Measurement of targeting accuracy 

and reproducibility of high intensity 

ultrasound output; 

(iii) Ultrasound-induced heating 

verification testing at target and nontarget tissues; 

(iv) Electrical safety testing; and 

(v) Electromagnetic compatibility 

testing. 

(2) Software verification, validation, 

and hazard analysis must be performed. 

(3) The elements of the device that 

may contact the patient’s mucosal tissue 

must be demonstrated to be 

biocompatible. 

(4) Performance data must 

demonstrate the sterility of the device 

components that contact the patient’s 

mucosal tissue. 

(5) Performance data must support 

shelf life by demonstrating continued 

sterility of the device or the sterile 

components, package integrity, and 

device functionality over the identified 

shelf life. 

(6) Performance data must support the 

instructions for reprocessing all reusable 

components. 

(7) In vivo testing must demonstrate 

that the device thermally ablates 

targeted tissue in a controlled manner 

without thermal injury to adjacent, nontarget tissues. 

(8) Clinical testing must document the 

adverse event profile, provide evidence 

of prostatic ablation, and demonstrate 

that the device performs as intended 

under anticipated conditions of use. 

(9) Training must be provided so that 

upon completion of the training 

program, the physician can: 

(i) Use all safety features of the 

device; 

(ii) Accurately target the high 

intensity ultrasound energy within the 

desired region of the prostate; and 

(iii) Perform the ablation procedure in 

a manner that minimizes damage to 

non-target tissues. 

(10) Labeling must include: 

(i) A section that summarizes the 

clinical testing results, including the 

adverse event profile and evidence of 

prostate ablation achieved; and 

(ii) An expiration date or shelf life for 

single use components. 

Dated: September 25, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–21074 Filed 9–29–17; 8:45 am] 

BILLING CODE 4164–01–P 


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