52644 Federal Register / Vol. 82, No. 218 / Tuesday, November 14, 2017 / Rules and Regulations 

reviewing the rulemaking record for the 

OLPP final rule, AMS discovered a 

significant, material error in the 

mathematical calculation of the benefits 

estimates. With the material error, the 

regulatory impact analysis presented 

costs and benefits in a table that could 

be reasonably interpreted to conclude 

that benefits were likely to exceed the 

costs. (82 FR 7083–82 FR 7084.) 

However, AMS believes that the 

regulatory impact analysis’ calculation 

of benefits was flawed because the 

incorrect calculation was applied for the 

3 percent and 7 percent discount rates. 

Re-analysis using the correct 

mathematical calculations suggests that 

this error was material. It is not 

appropriate for AMS to allow a final 

rule to become effective based on a 

record containing such a material error. 

AMS intends to seek public comment 

on the revised calculation of benefits. 

Due to these significant concerns 

regarding statutory authority for, and 

costs and benefits of, the OLPP rule, 

including the question whether the 

OLPP final rule was based on a 

mathematically flawed assessment of 

benefits, AMS is selecting Option 3: 

Delay. AMS is issuing this final rule to 

further delay the effective date for until 

May 14, 2018 to allow for AMS to issue 

another notice of proposed rulemaking 

to receive comments on USDA statutory 

authority under the OFPA to regulate 

animal welfare; the likely costs and 

benefits of the OLPP rule viewed in 

terms of the statutory objectives of the 

OPFA, as interpreted above; whether the 

OLPP rule’s requirements represent the 

most innovate and least burdensome 

way to achieve regulatory ends; and the 

revised calculations and analysis of the 

benefits of the OLPP rule. This delay 

will provide additional time for AMS to 

solicit comment on these important 

issues and review all the comments 

prior to making a final decision on the 

direction of the OLPP final rule. 

To preserve the status quo rather than 

allow an expansive set of new 

requirements to become effective only to 

be delayed, suspended, or withdrawn a 

short time later and to allow AMS to 

receive and consider comments on the 

issues discussed above, this final rule 

action is effective upon publication 

because AMS believes that the 30-day 

delay is impracticable, unnecessary, and 

contrary to the public interest. When 

agencies establish good cause for an 

immediate effective date, Congress 

intended that, combined with 

unavoidable time limitations, ‘‘the 

primary consideration was to be the 

‘convenience or necessity of the people 

affected.’ ’’ United States v. Gavrilovic, 

551 F.2d 1099, 1104 (8th Cir. 1977) 

(citing S.Rep.No.752, 79th Cong., 1st 

Sess. 15 (1946); H.R.Rep.No.1980, 79th 

Cong., 2d Sess. 25 (1946)). Ordinarily, 

the thirty-day waiting period gives 

stakeholders and the public a reasonable 

time to adjust behavior. Omnipoint 

Corp. v. F.C.C., 78 F.3d 620, 630 (D.C. 

Cir. 1996). In this case, however, a 

thirty-day waiting period would require 

stakeholders to begin changing their 

behavior to comply with the OLPP final 

rule, when that rule may be delayed, 

suspended, or withdrawn after the 

agency has completed review of 

comments in response to an notice of 

proposed rulemaking that will present 

the issues discussed above. It is also 

contrary to the public interest to allow 

a final rule that is based on a flawed 

record to become effective. Thus, and 

for the reasons stated above, waiting for 

thirty days to delay the effective date of 

the OLPP final rule is not warranted by 

‘‘convenience’’ and would be 

unnecessary and contrary to the public 

interest. 

Dated: November 8, 2017. 

Sonia N. Jimenez, 

Acting Associate Administrator, Agricultural 

Marketing Service. 

[FR Doc. 2017–24675 Filed 11–9–17; 8:45 am] 

BILLING CODE 3410–02–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2017–0712; Product 

Identifier 2017–NM–014–AD; Amendment 

39–19095; AD 2017–23–01] 

RIN 2120–AA64 

Airworthiness Directives; Bombardier, 

Inc., Airplanes 

AGENCY: Federal Aviation 

Administration (FAA), Department of 

Transportation (DOT). 

ACTION: Final rule. 

SUMMARY: We are superseding 

Airworthiness Directive (AD) 2016–13– 

14, which applied to certain 

Bombardier, Inc., Model DHC–8–400 

series airplanes. AD 2016–13–14 

required an inspection to determine if 

certain left and right main landing gear 

(MLG) retract actuator rod ends were 

installed, repetitive liquid penetrant 

inspections (LPIs) of affected left and 

right MLG retract actuator rod ends, and 

corrective actions if necessary. This new 

AD retains the actions specified in AD 

2016–13–14 and also requires 

replacement of the left and right MLG 

retract actuator rod ends. This AD was 

prompted by a report of a cracked MLG 

retract actuator rod end. We are issuing 

this AD to address the unsafe condition 

on these products. 

DATES: This AD is effective December 

19, 2017. 

The Director of the Federal Register 

approved the incorporation by reference 

of a certain publication listed in this AD 

as of July 20, 2016 (81 FR 43481, July 

5, 2016). 

ADDRESSES: For service information 

identified in this final rule, contact 

Bombardier, Inc., Q-Series Technical 

Help Desk, 123 Garratt Boulevard, 

Toronto, Ontario M3K 1Y5, Canada; 

telephone: 416–375–4000; fax: 416– 

375–4539; email: thd.qseries@

aero.bombardier.com; Internet: http://

www.bombardier.com. You may view 

this referenced service information at 

the FAA, Transport Standards Branch, 

1601 Lind Avenue SW., Renton, WA. 

For information on the availability of 

this material at the FAA, call 425–227– 

1221. It is also available on the Internet 

at http://www.regulations.gov by 

searching for and locating Docket No. 

FAA–2017–0712. 

Examining the AD Docket 

You may examine the AD docket on 

the Internet at http://

www.regulations.gov by searching for 

and locating Docket No. FAA–2017– 

0712; or in person at the Docket 

Management Facility between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. The AD docket 

contains this AD, the regulatory 

evaluation, any comments received, and 

other information. The address for the 

Docket Office (telephone: 800–647– 

5527) is Docket Management Facility, 

U.S. Department of Transportation, 

Docket Operations, M–30, West 

Building Ground Floor, Room W12–140, 

1200 New Jersey Avenue SE., 

Washington, DC 20590. 

FOR FURTHER INFORMATION CONTACT: Aziz 

Ahmed, Aerospace Engineer, Airframe 

and Mechanical Systems Section, FAA, 

New York ACO Branch, 1600 Stewart 

Avenue, Suite 410, Westbury, NY 

11590; telephone: 516–228–7329; fax: 

516–794–5531. 

SUPPLEMENTARY INFORMATION: 

Discussion 

We issued a notice of proposed 

rulemaking (NPRM) to amend 14 CFR 

part 39 to supersede AD 2016–13–14, 

Amendment 39–18579 (81 FR 43481, 

July 5, 2016) (‘‘AD 2016–13–14’’). AD 

2016–13–14 applied to certain 

Bombardier, Inc., Model DHC–8–400 

series airplanes. The NPRM published 

in the Federal Register on July 28, 2017 


jstallworth on DSKBBY8HB2PROD with RULES
Federal Register / Vol. 82, No. 218 / Tuesday, November 14, 2017 / Rules and Regulations 52645 

(82 FR 35127). The NPRM was 

prompted by a report of a cracked MLG 

retract actuator rod end. The NPRM 

proposed to continue to require the 

actions specified in AD 2016–13–14. 

The NPRM also proposed to require 

replacement of the left and right MLG 

retract actuator rod ends. We are issuing 

this AD to detect and correct fatigue 

cracking of the left and right MLG 

retract actuator rod ends, which could 

lead to left or right MLG collapse. 

Transport Canada Civil Aviation 

(TCCA), which is the aviation authority 

for Canada, has issued Canadian AD 

CF–2016–16R1, dated June 27, 2016 

(referred to after this as the Mandatory 

Continuing Airworthiness Information, 

or ‘‘the MCAI’’), to correct an unsafe 

condition for certain Bombardier, Inc. 

Model DHC–8–400 series airplanes. The 

MCAI states: 

There has been a single reported case of a 

cracked MLG retract actuator rod end in 

service. A supplier disclosure letter and 

subsequent Bombardier analysis indicate that 

the MLG retract actuator rod end P/N [part 

number] P3A2750 and P3A2750–1 may 

develop fatigue cracking. This condition, if 

not corrected, could lead to left hand (LH) or 

right hand (RH) MLG collapse. 

This [Canadian] AD mandates the 

inspection [to determine if certain left and 

right main landing gear MLG retract actuator 

rod ends are installed, repetitive LPIs of 

affected left and right MLG retract actuator 

rod ends, and corrective actions if necessary], 

and replacement of the LH and RH MLG 

retract actuator rod ends P/N P3A2750 and 

P3A2750–1 [which is terminating action for 

the repetitive LPIs]. 

This [Canadian] AD was revised to clarify 

paragraph B. and C. [of this Canadian AD], 

which specifies when the Liquid Penetrant 

Inspections (LPI) should begin. 

Corrective actions include replacing 

cracked MLG retract actuator rod ends. 

You may examine the MCAI in the AD 

docket on the Internet at http://

www.regulations.gov by searching for 

and locating Docket No. FAA–2017– 

0712. 

Comments 

We gave the public the opportunity to 

participate in developing this AD. We 

received no comments on the NPRM or 

on the determination of the cost to the 

public. 

Conclusion 

We reviewed the available data and 

determined that air safety and the 

public interest require adopting this AD 

as proposed except for minor editorial 

changes. We have determined that these 

minor changes: 

• Are consistent with the intent that 

was proposed in the NPRM for 

correcting the unsafe condition; and 

• Do not add any additional burden 

upon the public than was already 

proposed in the NPRM. 

Related Service Information Under 

1 CFR Part 51 

Bombardier, Inc., has issued 

Bombardier Service Bulletin 84–32–142, 

dated May 4, 2016. This service 

information describes procedures for an 

inspection to determine if certain left 

and right MLG retract actuator rod ends 

are installed, repetitive LPIs of the left 

and right MLG retract actuator rod ends, 

and replacement of left and right MLG 

retract actuator rod ends. This service 

information is reasonably available 

because the interested parties have 

access to it through their normal course 

of business or by the means identified 

in the ADDRESSES section. 

Costs of Compliance 

We estimate that this AD affects 52 

airplanes of U.S. registry. 

We estimate the following costs to 

comply with this AD: 

The actions required by AD 2016–13– 

14, and retained in this AD, take about 

1 work-hour per product, at an average 

labor rate of $85 per work-hour. Based 

on these figures, the estimated cost of 

the inspection that is required by AD 

2016–13–14 is $85 per product. 

We also estimate that it will take 

about 3 work-hours per product to 

comply with the basic requirements of 

this AD. The average labor rate is $85 

per work-hour. Required parts will cost 

about $2,019 per product. Based on 

these figures, we estimate the cost of 

this AD on U.S. operators to be 

$118,248, or $2,274 per product. 

In addition, we estimate that any 

necessary follow-on actions will take 

about 3 work-hours and require parts 

costing $2,019, for a cost of $2,274 per 

product. We have no way of 

determining the number of aircraft that 

might need these actions. 

According to the manufacturer, some 

of the costs of this AD may be covered 

under warranty, thereby reducing the 

cost impact on affected individuals. We 

do not control warranty coverage for 

affected individuals. As a result, we 

have included all available costs in our 

cost estimate. 

Authority for This Rulemaking 

Title 49 of the United States Code 

specifies the FAA’s authority to issue 

rules on aviation safety. Subtitle I, 

section 106, describes the authority of 

the FAA Administrator. ‘‘Subtitle VII: 

Aviation Programs,’’ describes in more 

detail the scope of the Agency’s 

authority. 

We are issuing this rulemaking under 

the authority described in ‘‘Subtitle VII, 

Part A, Subpart III, Section 44701: 

General requirements.’’ Under that 

section, Congress charges the FAA with 

promoting safe flight of civil aircraft in 

air commerce by prescribing regulations 

for practices, methods, and procedures 

the Administrator finds necessary for 

safety in air commerce. This regulation 

is within the scope of that authority 

because it addresses an unsafe condition 

that is likely to exist or develop on 

products identified in this rulemaking 

action. 

This AD is issued in accordance with 

authority delegated by the Executive 

Director, Aircraft Certification Service, 

as authorized by FAA Order 8000.51C. 

In accordance with that order, issuance 

of ADs is normally a function of the 

Compliance and Airworthiness 

Division, but during this transition 

period, the Executive Director has 

delegated the authority to issue ADs 

applicable to transport category 

airplanes to the Director of the System 

Oversight Division. 

Regulatory Findings 

We determined that this AD will not 

have federalism implications under 

Executive Order 13132. This AD will 

not have a substantial direct effect on 

the States, on the relationship between 

the national government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government. 

For the reasons discussed above, I 

certify that this AD: 

1. Is not a ‘‘significant regulatory 

action’’ under Executive Order 12866; 

2. Is not a ‘‘significant rule’’ under the 

DOT Regulatory Policies and Procedures 

(44 FR 11034, February 26, 1979); 

3. Will not affect intrastate aviation in 

Alaska; and 

4. Will not have a significant 

economic impact, positive or negative, 

on a substantial number of small entities 

under the criteria of the Regulatory 

Flexibility Act. 

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Incorporation by reference, 

Safety. 

Adoption of the Amendment 

Accordingly, under the authority 

delegated to me by the Administrator, 

the FAA amends 14 CFR part 39 as 

follows: 

PART 39—AIRWORTHINESS 

DIRECTIVES 

■ 1. The authority citation for part 39 

continues to read as follows: 


jstallworth on DSKBBY8HB2PROD with RULES
52646 Federal Register / Vol. 82, No. 218 / Tuesday, November 14, 2017 / Rules and Regulations 

Authority: 49 U.S.C. 106(g), 40113, 44701. 

§ 39.13 [Amended] 

■ 2. The FAA amends § 39.13 by 

removing Airworthiness Directive (AD) 

2016–13–14, Amendment 39–18579 (81 

FR 43481, July 5, 2016), and adding the 

following new AD: 

2017–23–01 Bombardier, Inc.: Amendment 

39–19095; Docket No. FAA–2017–0712; 

Product Identifier 2017–NM–014–AD. 

(a) Effective Date 

This AD is effective December 19, 2017. 

(b) Affected ADs 

This AD replaces AD 2016–13–14, 

Amendment 39–18579 (81 FR 43481, July 5, 

2016) (‘‘AD 2016–13–14’’). 

(c) Applicability 

This AD applies to Bombardier, Inc., 

Model DHC–8–400, –401 and –402 airplanes, 

certificated in any category, serial numbers 

4001, and 4003 through 4325 inclusive. 

(d) Subject 

Air Transport Association (ATA) of 

America Code 32, Landing gear. 

(e) Reason 

This AD was prompted by a report of a 

cracked main landing gear (MLG) retract 

actuator rod end. We are issuing this AD to 

detect and correct fatigue cracking of the left 

and right MLG retract actuator rod ends, 

which could lead to left or right MLG 

collapse. 

(f) Compliance 

Comply with this AD within the 

compliance times specified, unless already 

done. 

(g) Retained Part Number Inspection, With 

No Changes 

This paragraph restates the requirements of 

paragraph (g) of AD 2016–13–14, with no 

changes. Within 100 flight cycles after July 

20, 2016 (the effective date of AD 2016–13– 

14), inspect the left and right MLG retract 

actuator rod ends to determine if part number 

(P/N) P3A2750 or P3A2750–1 is installed. A 

review of airplane maintenance records is 

acceptable in lieu of this inspection if the 

part number can be conclusively determined 

from that review. 

(h) Retained Repetitive Liquid Penetrant 

Inspections (LPIs), With No Changes 

This paragraph restates the requirements of 

paragraph (h) of AD 2016–13–14, with no 

changes. For each left or right MLG retract 

actuator rod end having P/N P3A2750 or 

P3A2750–1: At the applicable time specified 

in paragraph (h)(1) or (h)(2) of this AD, do 

an LPI to detect cracks of the MLG retract 

actuator rod end, in accordance with the 

Accomplishment Instructions of Bombardier 

Service Bulletin 84–32–142, dated May 4, 

2016, except as required by paragraph (k) of 

this AD. Thereafter, repeat the LPI at 

intervals not to exceed 600 flight cycles. 

(1) If the MLG retract actuator rod end has 

accumulated more than 6,000 flight cycles as 

of July 20, 2016 (the effective date of AD 

2016–13–14): Inspect within 100 flight cycles 

after July 20, 2016. 

(2) If the MLG retract actuator rod end has 

accumulated 6,000 flight cycles or fewer as 

of July 20, 2016 (the effective date of AD 

2016–13–14): Inspect within 600 flight cycles 

after July 20, 2016. 

(i) Retained Corrective Action, With No 

Changes 

This paragraph restates the requirements of 

paragraph (i) of AD 2016–13–14, with no 

changes. If any crack is found during any 

inspection required by paragraph (h) of this 

AD, before further flight, replace the cracked 

MLG retract actuator rod end, P/N P3A2750 

or P3A2750–1, with a MLG retract actuator 

rod end, P/N P3A6460, in accordance with 

the Accomplishment Instructions of 

Bombardier Service Bulletin 84–32–142, 

dated May 4, 2016, except as required by 

paragraph (k) of this AD. 

(j) Retained Optional Replacement, With No 

Changes 

This paragraph restates the optional 

replacement specified in paragraph (j) of AD 

2016–13–14, with no changes. Replacement 

of the left and right side MLG retract actuator 

rod ends, P/N P3A2750 or P3A2750–1, with 

left and right MLG retract actuator rod ends, 

P/N P3A6460, in accordance with the 

Accomplishment Instructions of Bombardier 

Service Bulletin 84–32–142, dated May 4, 

2016, except as required by paragraph (k) of 

this AD, constitutes terminating action for 

the actions required by paragraphs (g) and (h) 

of this AD for that airplane. 

(k) Retained Exception, With No Changes 

This paragraph restates the requirements of 

paragraph (k) of AD 2016–13–14, with no 

changes. If it is not possible to complete all 

the instructions in Bombardier Service 

Bulletin 84–32–142, dated May 4, 2016, 

because of the configuration of the airplane: 

Before further flight, repair using a method 

approved by the Manager, New York ACO 

Branch, FAA; or Transport Canada Civil 

Aviation (TCCA); or Bombardier, Inc.’s TCCA 

Design Approval Organization (DAO). 

(l) Retained Parts Installation Prohibition, 

With No Changes 

This paragraph restates the requirements of 

paragraph (l) of AD 2016–13–14, with no 

changes. As of July 20, 2016 (the effective 

date of AD 2016–13–14), no person may 

install a left or right MLG retract actuator rod 

end, P/N P3A2750 or P3A2750–1, on any 

airplane. 

(m) New Requirement of This AD: 

Replacement 

Within 1,800 flight cycles after 

accomplishing the initial inspection required 

by paragraph (g) of this AD, replace the left 

and right side MLG retract actuator rod ends 

having P/N P3A2750 or P3A2750–1, with left 

and right MLG retract actuator rod ends 

having P/N P3A6460, in accordance with the 

Accomplishment Instructions of Bombardier 

Service Bulletin 84–32–142, dated May 4, 

2016, except as required by paragraph (k) of 

this AD. Accomplishing this replacement 

terminates the requirements of paragraphs (g) 

and (h) of this AD for that airplane. 

(n) Other FAA AD Provisions 

The following provisions also apply to this 

AD: 

(1) Alternative Methods of Compliance 

(AMOCs): The Manager, New York ACO 

Branch, FAA, has the authority to approve 

AMOCs for this AD, if requested using the 

procedures found in 14 CFR 39.19. In 

accordance with 14 CFR 39.19, send your 

request to your principal inspector or local 

Flight Standards District Office, as 

appropriate. If sending information directly 

to the manager of the certification office, 

send it to ATTN: Program Manager, 

Continuing Operational Safety, FAA, New 

York ACO Branch, 1600 Stewart Avenue, 

Suite 410, Westbury, NY 11590; telephone: 

516–228–7300; fax: 516–794–5531. Before 

using any approved AMOC, notify your 

appropriate principal inspector, or lacking a 

principal inspector, the manager of the local 

flight standards district office/certificate 

holding district office. 

(2) Contacting the Manufacturer: For any 

requirement in this AD to obtain corrective 

actions from a manufacturer, the action must 

be accomplished using a method approved 

by the Manager, New York ACO Branch, 

FAA; or TCCA; or Bombardier Inc.’s TCCA 

DAO. If approved by the DAO, the approval 

must include the DAO-authorized signature. 

(o) Related Information 

(1) Refer to Mandatory Continuing 

Airworthiness Information (MCAI) Canadian 

AD CF–2016–16R1, dated June 27, 2016, for 

related information. This MCAI may be 

found in the AD docket on the Internet at 

http://www.regulations.gov by searching for 

and locating Docket No. FAA–2017–0712. 

(2) For more information about this AD, 

contact Aziz Ahmed, Aerospace Engineer, 

Airframe and Mechanical Systems Section, 

FAA, New York ACO Branch, 1600 Stewart 

Avenue, Suite 410, Westbury, NY 11590; 

telephone: 516–228–7329; fax: 516–794– 

5531. 

(p) Material Incorporated by Reference 

(1) The Director of the Federal Register 

approved the incorporation by reference 

(IBR) of the service information listed in this 

paragraph under 5 U.S.C. 552(a) and 1 CFR 

part 51. 

(2) You must use this service information 

as applicable to do the actions required by 

this AD, unless this AD specifies otherwise. 

(3) The following service information was 

approved for IBR on July 20, 2016 (81 FR 

43481, July 5, 2016). 

(i) Bombardier Service Bulletin 84–32–142, 

dated May 4, 2016. 

(ii) Reserved. 

(4) For service information identified in 

this AD, contact Bombardier, Inc., Q-Series 

Technical Help Desk, 123 Garratt Boulevard, 

Toronto, Ontario M3K 1Y5, Canada; 

telephone: 416–375–4000; fax: 416–375– 

4539; email: thd.qseries@

aero.bombardier.com; Internet: http://

www.bombardier.com. 

(5) You may view this service information 

at the FAA, Transport Standards Branch, 

1601 Lind Avenue SW., Renton, WA. For 

information on the availability of this 

material at the FAA, call 425–227–1221. 


jstallworth on DSKBBY8HB2PROD with RULES
Federal Register / Vol. 82, No. 218 / Tuesday, November 14, 2017 / Rules and Regulations 52647 

(6) You may view this service information 

that is incorporated by reference at the 

National Archives and Records 

Administration (NARA). For information on 

the availability of this material at NARA, call 

202–741–6030, or go to: http://

www.archives.gov/federal-register/cfr/ibrlocations.html. 

Issued in Renton, Washington, on October 

30, 2017. 

Jeffrey E. Duven, 

Director, System Oversight Division, Aircraft 

Certification Service. 

[FR Doc. 2017–24166 Filed 11–13–17; 8:45 am] 

BILLING CODE 4910–13–P 

TENNESSEE VALLEY AUTHORITY 

18 CFR Part 1301 

Privacy Act Regulations; Correction 

Correction 

In rule document 2017–24300, 

appearing on pages 51757–51758 in the 

issue of Wednesday, November 8, 2017, 

make the following correction: 

■ On page 51757 in the second column, 

remove Amendatory instruction 2. 

Dates: This correction is effective on 

November 8, 2017. 

[FR Doc. C1–2017–24300 Filed 11–9–17; 4:15 pm] 

BILLING CODE 1301–00–D 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 866 

[Docket No. FDA–2017–N–5881] 

Medical Devices; Immunology and 

Microbiology Devices; Classification of 

the Automated Indirect 

Immunofluorescence Microscope and 

Software-Assisted System 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

classifying the automated indirect 

immunofluorescence microscope and 

software-assisted system 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 

automated indirect immunofluorescence 

microscope and software-assisted 

system’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 November 

14, 2017. The classification was 

applicable on April 9, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Steven Tjoe, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4550, Silver Spring, 

MD 20993–0002, 301–796–5866, 

steven.tjoe@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Upon request, FDA has classified the 

automated indirect immunofluorescence 

microscope and software-assisted 

system 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 

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 (21 

U.S.C. 360c(i)) to a predicate device that 

does not require premarket approval. 

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 is required to 

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 

placed 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 (PMA) 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 

For this device, FDA issued an order 

on November 14, 2014, finding the 

NOVA View® Automated Fluorescence 

Microscope not substantially equivalent 

to a predicate not subject to PMA. Thus, 

the device remained in class III in 

accordance with section 513(f)(1) of the 

FD&C Act when we issued the order. 

On December 11, 2014, Inova 

Diagnostics, Inc. submitted a request for 

De Novo classification of the NOVA 


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