Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Proposed Rules 51585 

(Piper) Service Bulletin (SB) No. 1304, dated 

August 23, 2017. 

(h) Install Inspection Access Panels 

If it is determined that no inspection access 

panels are present during the inspection 

required in paragraph (g) of this AD, within 

the next 100 hours TIS after the effective date 

of this AD or within the next 12 months after 

the effective date of this AD, whichever 

occurs first install inspection access panels 

on the lower skin of the left wing and the 

right wing using Piper SB No. 1304, dated 

August 23, 2017. 

(i) Inspect for Corrosion 

Within the next 100 hours TIS after the 

effective date of this AD or within the next 

12 months after the effective date of this AD, 

whichever occurs first, inspect the left and 

the right main wing spar for any evidence of 

corrosion using Part I of the Instructions 

section of Piper SB No. 1304, dated August 

23, 2017. 

(j) Corrective Actions 

Before further flight after the inspection 

required in paragraph (i) of this AD, if 

evidence of corrosion is found, take all 

necessary corrective actions to remove the 

corrosion using Part I of the Instructions 

section of Piper SB No. 1304, dated August 

23, 2017, and/or make all necessary repairs 

using Part II of the Instructions section of 

Piper SB No. 1304, dated August 23, 2017. 

(k) Alternative Methods of Compliance 

(AMOCs) 

(1) The Manager, Atlanta 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 the attention of 

the person identified in paragraph (l)(1) of 

this AD. 

(2) 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. 

(3) For service information that contains 

steps that are labeled as Required for 

Compliance (RC), the provisions of 

paragraphs (g) through (j) of this AD apply. 

(i) The steps labeled as RC, including 

substeps under an RC step and any figures 

identified in an RC step, must be done to 

comply with the AD. An AMOC is required 

for any deviations to RC steps, including 

substeps and identified figures. 

(ii) Steps not labeled as RC may be 

deviated from using accepted methods in 

accordance with the operator’s maintenance 

or inspection program without obtaining 

approval of an AMOC, provided the RC steps, 

including substeps and identified figures, can 

still be done as specified, and the airplane 

can be put back in an airworthy condition. 

(l) Related Information 

(1) For more information about this AD, 

contact Dan McCully, Aerospace Engineer, 

FAA, Atlanta ACO Branch, 1701 Columbia 

Avenue, College Park, Georgia 30337; 

telephone: (404) 474–5548; fax: (404) 474– 

5606; email: william.mccully@faa.gov. 

(2) For service information identified in 

this AD, contact Piper Aircraft, Inc., 2926 

Piper Drive, Vero Beach, Florida 32960; 

telephone: (772) 567–4361; Internet: 

www.piper.com. You may review this 

referenced service information at the FAA, 

Policy and Innovation Division, 901 Locust, 

Kansas City, Missouri 64106. For information 

on the availability of this material at the 

FAA, call (816) 329–4148. 

Issued in Kansas City, Missouri, on 

October 30, 2017. 

Melvin J. Johnson, 

Acting Deputy Director, Policy & Innovation 

Division, Aircraft Certification Service. 

[FR Doc. 2017–24083 Filed 11–6–17; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 880 

[Docket No. FDA–2017–N–6216] 

General Hospital and Personal Use 

Devices; Reclassification of Sharps 

Needle Destruction Device 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed order. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing this 

proposed order to reclassify the needle 

destruction device, renaming the device 

to ‘‘sharps needle destruction device,’’ a 

postamendments class III device 

(regulated under product code MTV), 

into class II (special controls), subject to 

premarket notification. FDA is also 

identifying the proposed special 

controls that the Agency believes are 

necessary to provide a reasonable 

assurance of safety and effectiveness of 

the device. FDA is proposing this 

reclassification on its own initiative 

based on new information. If finalized, 

this order will reclassify these types of 

devices from class III to class II and 

reduce regulatory burdens on industry 

as these types of devices will no longer 

be required to submit a premarket 

approval application (PMA) but can 

instead submit a less burdensome 

premarket notification (510(k)) before 

marketing their device. 

DATES: Submit either electronic or 

written comments on the proposed 

order by January 8, 2018. Please see 

section XI of this document for the 

proposed effective date when the new 

requirements apply and for the 

proposed effective date of a final order 

based on this proposed order. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before January 8, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of January 8, 2018. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal Rulemaking Portal: https:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2017–N–6216 for ‘‘General Hospital and 

Personal Use Devices; Reclassification 


nshattuck on DSK9F9SC42PROD with PROPOSALS
51586 Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Proposed Rules 

1FDA approved a modified needle destruction 

device on February 11, 1998. The device, as 

modified, is marketed under the trade name NeedleEase®3500. 

2See PMA database for original PMAs regulated 

under the product code MTV: https://www.access

data.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm. 

of Sharps Needle Destruction Device.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov

/fdsys/pkg/FR-2015-09-18/pdf/2015-

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Christopher K. Dugard, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 2561, 

Silver Spring, MD 20993, 240–402– 

6031, christopher.dugard@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background—Regulatory Authorities 

The Federal Food, Drug, and Cosmetic 

Act (the FD&C Act), as amended, 

establishes a comprehensive system for 

the regulation of medical devices 

intended for human use. Section 513 of 

the FD&C Act (21 U.S.C. 360c) 

established three categories (classes) of 

devices, reflecting the regulatory 

controls needed to provide reasonable 

assurance of their safety and 

effectiveness. The three categories of 

devices are class I (general controls), 

class II (special controls), and class III 

(premarket approval). 

Devices that were not in commercial 

distribution prior to May 28, 1976 

(generally referred to as 

postamendments devices) are 

automatically classified by section 

513(f)(1) of the FD&C Act into class III 

without any FDA rulemaking process. 

Those devices remain in class III and 

require premarket approval unless, and 

until, the device is reclassified into class 

I or II, or FDA issues an order finding 

the device to be substantially 

equivalent, in accordance with section 

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

device that does not require premarket 

approval. The Agency determines 

whether new devices are substantially 

equivalent to predicate devices by 

means of premarket notification 

procedures in section 510(k) of the 

FD&C Act (21 U.S.C. 360(k)) and 21 CFR 

part 807. 

A postamendments device that has 

been initially classified in class III 

under section 513(f)(1) of the FD&C Act 

may be reclassified into class I or class 

II under section 513(f)(3) of the FD&C 

Act. Section 513(f)(3) of the FD&C Act 

provides that FDA acting by order can 

reclassify the device into class I or class 

II on its own initiative, or in response 

to a petition from the manufacturer or 

importer of the device. To change the 

classification of the device, the 

proposed new class must have sufficient 

regulatory controls to provide 

reasonable assurance of the safety and 

effectiveness of the device for its 

intended use. 

Reevaluation of the data previously 

before the Agency is an appropriate 

basis for subsequent action where the 

reevaluation is made in light of newly 

available regulatory authority (see Bell 

v. Goddard, 366 F.2d 177, 181 (7th Cir. 

1966); Ethicon, Inc. v. FDA, 762 F. 

Supp. 382, 388–391 (D.D.C. 1991)) or in 

light of changes in ‘‘medical science’’ 

(Upjohn v. Finch, 422 F.2d 944, 951 (6th 

Cir. 1970)). Whether data before the 

Agency are old or new, the ‘‘new 

information’’ to support reclassification 

under 513(f)(3) must be ‘‘valid scientific 

evidence’’, as defined in section 

513(a)(3) of the FD&C Act and 21 CFR 

860.7(c)(2). (See, e.g., General Medical 

Co. v. FDA, 770 F.2d 214 (D.C. Cir. 

1985); Contact Lens Assoc. v. FDA, 766 

F.2d 592 (D.C. Cir.1985), cert. denied, 

474 U.S. 1062 (1986)). 

FDA relies upon ‘‘valid scientific 

evidence’’ in the classification process 

to determine the level of regulation for 

devices. To be considered in the 

reclassification process, the ‘‘valid 

scientific evidence’’ upon which the 

Agency relies must be publicly 

available. Publicly available information 

excludes trade secret and/or 

confidential commercial information, 

e.g., the contents of a pending PMA (see 

section 520(c) of the FD&C Act (21 

U.S.C. 360j(c)). Section 520(h)(4) of the 

FD&C Act provides that FDA may use, 

for reclassification of a device, certain 

information in a PMA 6 years after the 

application has been approved. This 

includes information from clinical and 

preclinical tests or studies that 

demonstrate the safety or effectiveness 

of the device, but does not include 

descriptions of methods of manufacture 

or product composition and other trade 

secrets. 

Section 510(m) of the FD&C Act 

provides that a class II device may be 

exempted from the 510(k) premarket 

notification requirements, if the Agency 

determines that premarket notification 

is not necessary to reasonably assure the 

safety and effectiveness of the device. 

II. Regulatory History of the Devices 

On February 3, 1994, FDA issued a 

Memorandum to manufacturers and 

initial distributors of sharps containers 

and destroyers used by health care 

manufacturers to clarify the regulatory 

status of sharps destroyer devices (Ref. 

1). 

On March 6, 1997, FDA approved its 

first needle destruction device through 

its PMA process under section 515 of 

the FD&C Act (21 U.S.C. 360e). In the 

June 11, 1997, Federal Register notice 

(62 FR 31831), FDA announced a PMA 

approval order for Millenium Medical 

Supply’s Incorporated Needle-EaseTM

25011 device and the availability of the 

Summary of Safety and Effectiveness 

Data for the Device (SSED) (Ref. 2). As 

of the date of issuance of this proposed 

order, FDA has approved 18 original 

PMAs for this device type.2


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On March 2, 2001, FDA finalized 

guidance entitled, ‘‘Premarket Approval 

Applications (PMA) for Sharps Needle 

Destruction Devices,’’ describing the 

Agency’s recommendations for 

information to include in PMA 

applications for sharps needle 

destruction devices intended for use in 

health care settings (Ref. 3). 

III. Device Description 

A sharps needle destruction device is 

a postamendments device classified into 

class III under section 513(f)(1) of the 

FD&C Act. A sharps needle destruction 

device is a prescription device intended 

for home use or in professional health 

care facilities to destroy sharps or 

needles used for medical purposes by 

incineration or mechanical means. 

Sharps needle destruction devices are 

typically electrical devices that can 

destruct sharps and/or needles in a 

variety of methods (grinding, 

incinerating, etc.) that can be either 

portable or stationary. Some of these 

devices may also employ software to 

provide the user with greater control. 

Please note these devices were 

originally identified as needle 

destruction devices (product code MTV) 

in FDA SSEDs and product code 

database; however, FDA believes the 

identification of sharps needle 

destruction device more accurately 

describes this device type as it can be 

used to destroy devices other than 

needles (e.g., sharps). 

IV. Proposed Reclassification 

As part of the Center for Devices and 

Radiological Health’s 2014–2015 

strategic priority ‘‘Strike the Right 

Balance Between Premarket and 

Postmarket Data Collection,’’ a 

retrospective review of class III devices 

subject to PMA was completed to 

determine whether or not, based on our 

current understanding of the 

technology, reclassification may be 

appropriate. On August 8, 2016, FDA 

published a document in the Federal 

Register entitled ‘‘Retrospective Review 

of Premarket Approval Application 

Devices; Striking the Balance Between 

Premarket and Postmarket Data 

Collection’’ in which FDA announced 

plans to reclassify sharps needle 

destruction devices identified with the 

MTV product code from class III to class 

II (81 FR 52445). FDA has found that 

sufficient information exists to establish 

special controls that, together with 

general controls, can provide a 

reasonable assurance of safety and 

effectiveness for sharps needle 

destruction devices. 

In accordance with section 513(f)(3) of 

the FD&C Act and 21 CFR part 860, 

subpart C, FDA is proposing to 

reclassify this postamendments class III 

device into class II. FDA believes that 

there is sufficient information available 

to FDA through FDA’s accumulated 

experience with these devices from 

review submissions, peer-reviewed 

literature, and knowledge of similar 

devices to establish special controls that 

effectively mitigate the risks to health 

identified in section V. Absent the 

special controls identified in this 

proposed order, general controls 

applicable to the device are insufficient 

to provide reasonable assurance of the 

safety and effectiveness of the device. 

FDA is proposing to create a separate 

classification regulation for sharps 

needle destruction devices that will be 

reclassified from class III to II. Under 

this proposed order, if finalized, the 

sharps needle destruction devices will 

be identified as a prescription device. 

As such, the prescription device must 

satisfy prescription labeling 

requirements (see § 801.109 (21 CFR 

801.109), Prescription devices). 

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 § 801.5 (21 CFR 801.5), as 

long as the conditions of § 801.109 are 

met. In this proposed order, if finalized, 

the Agency has identified the special 

controls under section 513(a)(1)(B) of 

the FD&C Act that, together with general 

controls, will provide a reasonable 

assurance of the safety and effectiveness 

for sharps needle destruction devices. 

Section 510(m) of the FD&C Act 

provides that FDA may exempt a class 

II device from the premarket notification 

requirements under section 510(k) of the 

FD&C Act if FDA determines that 

premarket notification is not necessary 

to provide reasonable assurance of the 

safety and effectiveness of the device. 

For this type of device, FDA has 

determined that premarket notification 

is necessary for sharps needle 

destruction devices to provide 

reasonable assurance of the safety and 

effectiveness. Therefore, the Agency 

does not intend to exempt these 

proposed class II devices from 510(k) 

requirements. Persons who intend to 

market this type of device must submit 

to FDA a 510(k) and receive clearance 

prior to marketing the device. 

V. Risks to Health 

After considering the information 

available to FDA through review 

submissions, peer-reviewed literature, 

and knowledge of similar devices, FDA 

determined the probable risks to health 

associated with the use of sharps needle 

destruction devices are as follows: 

• Patient/user exposure to 

environmental contaminants. 

Destroying a used sharp or needle may 

generate hazardous emissions from the 

device that may result in infection or 

respiratory problems for the patient 

and/or user. Contamination of the 

patient environment can occur through 

emission of toxic fumes or infectious 

aerosol when the device destroys a 

sharp by incineration or mechanical 

means, and may result from device 

malfunction (mechanical and/or 

software). The device may also become 

contaminated through regular usage and 

may cause cross-contamination. 

• Patient/user burns as a result of 

excessive heat discharge or spark 

formation. Excessive heat or sparks may 

be generated and discharged from the 

device during destruction of sharps that 

may burn the user. 

• Electromagnetic interference. While 

in operation, the device may interfere 

with other electrically powered devices, 

causing them to malfunction. 

• Electrical shock. While in 

operation, the device may discharge 

electricity that could shock the user. 

• Sharps injury. Incompletely 

destroyed sharps, physical device 

instability, device malfunctions, or use 

error may pose a risk for a sharps injury 

to the user. 

VI. Summary of Reasons for 

Reclassification 

FDA believes that the sharps needle 

destruction devices intended for home 

use or in professional health care 

facilities to reduce the incidence of 

needlesticks by destroying sharps and/ 

or needles in a variety of methods 

(grinding, incinerating, etc.) should be 

reclassified from class III to class II in 

light of new information about the 

effectiveness of these devices. There is 

sufficient information to establish 

special controls for sharps needle 

destruction devices, in addition to 

general controls, which can provide 

reasonable assurance of safety and 

effectiveness of the device, as general 

controls themselves are insufficient to 

provide reasonable assurance of its 

safety and effectiveness. FDA believes 

that the risks to health associated with 

sharps needle destruction devices 

intended for home use or in professional 

health care facilities to reduce the 

incidence of needlesticks can be 

mitigated with special controls and that 

these mitigations will provide a 

reasonable assurance of its safety and 

effectiveness. 

Based on a reconsideration of the 

available information and data, FDA 

believes that there is valid scientific 

evidence of effectiveness for sharps 


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51588 Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Proposed Rules 

needle destruction devices to reduce the 

incidence of needlesticks. 

VII. Summary of Data Upon Which the 

Reclassification Is Based 

FDA believes that the identified 

special controls, in addition to general 

controls, are necessary to provide 

reasonable assurance of safety and 

effectiveness of these devices. Taking 

into account the probable health 

benefits of the use of the device and the 

nature and known incidence of the risks 

of the device, FDA, on its own initiative, 

is proposing to reclassify this 

postamendments class III device into 

class II. FDA has considered and 

analyzed the following information: An 

inclusive search of the Agency’s 

Manufacturer and User Facility Device 

Experience (MAUDE) database, which 

shows no adverse events for sharps 

needle destruction devices; data 

contained in PMAs approved 6 or more 

years before the date of this proposal 

(reviewed under section 520(h)(4) of the 

FD&C Act, also known as the 6-year 

rule); a review of sharps containers 

regulated under 21 CFR 880.5570, 

which have similar intended uses, but 

different technology, and are currently 

regulated as class II devices; and one 

relevant article found from a literature 

search that discussed the benefits and 

the probable risks of these devices (Ref. 

4). 

VIII. Proposed Special Controls 

FDA believes that the following 

special controls, together with general 

controls, are sufficient to mitigate the 

risks to health described in section V 

and provide a reasonable assurance of 

safety and effectiveness for sharps 

needle destruction devices. 

• Performance testing will 

demonstrate: 

Æ The device’s ability to contain or 

ventilate aerosols or fumes from device 

operation that may result in 

environmental contamination and crosscontamination. Performance testing will 

demonstrate that harmful fumes, such as 

ozone, are not emitted by the device 

during destruction of sharps needles. 

Æ Excessive heat or sparks are not 

generated during device operation that 

may injure users or patients through 

characterization of the heat dissipation 

profile from the heat source to the 

enclosure surface, and the point of 

contact between the held syringe and 

the user. Performance testing will 

ensure the heat generated through 

normal operation of the device will not 

harm users or patients or affect circuit 

performance and useful life of the 

device. 

Æ Complete destruction of sharps 

intended to be destructed to mitigate 

user injuries from incomplete sharps 

destruction by conducting performance 

testing such as simulated use 

demonstrating complete destruction of 

the sharps and/or needles intended to 

be destroyed. 

Æ Mitigation of injuries from device 

instability through characterization of 

the vibrations and movement generated 

by the device to ensure device stability 

in the use environment. 

• Validation of cleaning and 

disinfection instructions to demonstrate 

that the device can be safely and 

effectively reprocessed after use to 

minimize the risk of patient/user crosscontamination. 

• Performance testing ensures 

electromagnetic compatibility with 

other devices under conditions which 

are consistent with the intended 

environment of device use. 

• Electrical safety testing ensures the 

risk of shock to the patient/user is 

minimized. 

• Software hazard analysis, as well as 

software verification and validation, 

ensures that software performs as 

intended and potential software 

malfunctions do not impact the 

performance of the device. 

• Labeling to ensure proper use of the 

device, including warnings of the 

generation of excessive heat, potential 

for needle stick injuries, instructions for 

reprocessing, and instructions for 

installation (e.g., on a stable surface, 

adequate ventilation). 

Table 1 shows how FDA believes 

these special controls will mitigate each 

risk to health described in section V. 

TABLE 1—RISKS TO HEALTH AND MITIGATION MEASURES FOR SHARPS

NEEDLE DESTRUCTION DEVICES

Identified risk to 

health Mitigation measures 

Patient/user exposure 

to environmental 

contaminants.

Performance testing. 

Reprocessing validation. 

Software verification, 

validation, and hazard analysis. 

Labeling. 

Patient/user burns ..... Performance testing. 

Labeling. 

Electrical shock ......... Electrical Safety Testing. 

Labeling. 

Electromagnetic interference.Electromagnetic 

Compatibility 

(EMC) Testing. 

Labeling. 

TABLE 1—RISKS TO HEALTH AND MITIGATION MEASURES FOR SHARPS

NEEDLE DESTRUCTION DEVICES— 

Continued 

Identified risk to 

health Mitigation measures 

Sharps injury ............. Performance testing. 

Software verification, 

validation, and hazard analysis. 

Labeling. 

In addition, FDA is proposing to limit 

these devices to prescription use under 

§ 801.109. 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 and § 801.5, as long as the 

conditions of § 801.109 are met 

(referring to 21 U.S.C. 352(f)(1)). Under 

21 CFR 807.81, the device would 

continue to be subject to 510(k) 

notification requirements. FDA does not 

believe that clinical data is necessary to 

mitigate the identified risks to health for 

sharps needle destruction devices. FDA 

may request clinical data to evaluate 

substantial equivalence when a 

manufacturer includes new indications 

for use, such as indications for disease 

prevention or organism destruction. 

This reclassification order and the 

identified special controls, if finalized, 

would provide sufficient detail 

regarding FDA’s requirements to 

reasonably assure safety and 

effectiveness of sharps needle 

destruction devices. FDA intends to 

withdraw the final guidance entitled, 

‘‘Premarket Approval Applications 

(PMA) for Sharps Needle Destruction 

Devices; Final Guidance for Industry 

and FDA’’ issued in 2001 upon 

finalization of this proposed 

reclassification order (Ref. 3). 

IX. 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. 

X. Paperwork Reduction Act of 1995 

FDA tentatively concludes that this 

proposed order contains no new 

collections of information. Therefore, 

clearance by the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA) (44 U.S.C. 

3501–3520) is not required. This 

proposed order refers to previously 

approved collections of information 


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Federal Register / Vol. 82, No. 214 / Tuesday, November 7, 2017 / Proposed Rules 51589 

found in FDA regulations. These 

collections of information are subject to 

review by OMB under the PRA. The 

collections of information in 21 CFR 

part 807, subpart E have been approved 

under OMB control number 0910–0120 

and the collections of information under 

21 CFR part 801 have been approved 

under OMB control number 0910–0485. 

XI. Proposed Effective Date 

FDA proposes that any final order 

based on this proposal become effective 

30 days after the date of its publication 

in the Federal Register. 

XII. References 

The following references are on 

display in the Dockets Management 

Staff (see ADDRESSES) and are available 

for viewing by interested persons 

between 9 a.m. and 4 p.m., Monday 

through Friday; they are also available 

electronically at https://

www.regulations.gov. FDA has verified 

the Web site addresses, as of the date 

this document publishes in the Federal 

Register, but Web sites are subject to 

change over time. 

1. FDA memorandum ‘‘To Manufacturers 

and Initial Distributors of Sharps Containers 

and Destroyers Used by Health Care 

Professionals,’’ February 3, 1994, available at: 

https://www.fda.gov/downloads/medical

devices/deviceregulationandguidance/ 

guidancedocuments/ucm070679.pdf. 

2. FDA ‘‘Premarket Approval of Millenium 

Medical Supply Incorporated Needle-EaseTM

2501–ACTION,’’ March 6, 1997, available at: 

https://www.accessdata.fda.gov/cdrh_docs/ 

pdf/p960044.pdf. 

3. ‘‘Premarket Approval Applications 

(PMA) for Sharps Needle Destruction 

Devices; Final Guidance for Industry and 

FDA,’’ March 2, 2001, available at: https://

www.fda.gov/downloads/MedicalDevices/ 

DeviceRegulationandGuidance/Guidance

Documents/ucm073601.pdf. 

4. Tamplin S.A., D. Davidson, B. Powis, 

and Z. O’Leary, ‘‘Issues and Options for the 

Safe Destruction and Disposal of Used 

Injection Materials,’’ Waste Management, vol. 

25, pp. 655–665, 2005. 

List of Subjects in 21 CFR Part 880 

Medical devices. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 321 

et seq., as amended) and under 

authority delegated to the Commissioner 

of Food and Drugs, it is proposed that 

21 CFR part 880 be amended as follows: 

PART 880—GENERAL HOSPITAL AND 

PERSONAL USE DEVICES 

■ 1. The authority citation for part 880 

continues to read as follows: 

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

360j, 371. 

■ 2. Add § 880.6210 to subpart G to read 

as follows: 

§ 880.6210 Sharps needle destruction 

device. 

(a) Identification. A sharps needle 

destruction device is a prescription 

device that is intended to destroy 

needles or sharps used for medical 

purposes by incineration or mechanical 

means. 

(b) Classification. Class II (special 

controls). The special controls for this 

device are: 

(1) Performance testing must 

demonstrate the following during 

operation of the device: 

(i) The device safely contains or 

ventilates aerosols or fumes from device 

operation. 

(ii) Excessive heat or sparks are not 

generated that may injure users or 

patients. 

(iii) Simulated use testing must 

demonstrate sharps and/or needles are 

completely destroyed using a range of 

types and sizes of sharps sufficient to 

represent actual use. 

(iv) Simulated use testing must 

demonstrate that the device is 

physically stable on the surface for 

which it is intended to be mounted to 

ensure the risk of harm to the patient/ 

user as a result of the device falling is 

minimized. 

(2) Validation of cleaning and 

disinfection instructions must 

demonstrate that the device can be 

safely and effectively reprocessed after 

use per the recommended cleaning and 

disinfection protocol in the instructions 

for use. 

(3) Analysis and/or testing must 

validate electromagnetic compatibility 

(EMC) and electrical safety, including 

the safety of any battery used in the 

device, under conditions which are 

consistent with the intended 

environment of device use. 

(4) Software verification, validation, 

and hazard analysis must be performed. 

(5) Labeling must include: 

(i) A clear description of the device 

and its technological features; 

(ii) How the device is to be used, 

including validated cleaning and 

disinfection instructions; 

(iii) Relevant precautions and 

warnings based on performance and inuse testing to ensure proper use of the 

device; and 

(iv) Instructions to install device in 

adequately ventilated area and stable 

area. 

Dated: November 2, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–24191 Filed 11–6–17; 8:45 am] 

BILLING CODE 4164–01–P 

LIBRARY OF CONGRESS 

Copyright Royalty Board 

37 CFR Part 381 

[Docket No. 16–CRB–0002–PBR (2018– 

2022)] 

Determination of Rates and Terms for 

Public Broadcasting (PB III) 

AGENCY: Copyright Royalty Board (CRB), 

Library of Congress. 

ACTION: Proposed rule. 

SUMMARY: The Copyright Royalty Judges 

solicit comments on proposed rates and 

terms for use of certain works in 

connection with noncommercial 

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January 1, 2018, and ending on 

December 31, 2022. 

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