8146 Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Rules and Regulations 

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 Kansas City, Missouri, on 

February 10, 2016. 

Pat Mullen, 

Acting Manager, Small Airplane Directorate, 

Aircraft Certification Service. 

[FR Doc. 2016–03307 Filed 2–17–16; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 888 

[Docket No. FDA–2011–N–0661] 

Effective Date of Requirement for 

Premarket Approval for Total Metal-onMetal Semi-Constrained Hip Joint 

Systems 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing a final 

order to require the filing of a premarket 

approval application (PMA) or a notice 

of completion of a product development 

protocol (PDP) for the hip joint metal/ 

metal semi-constrained, with a 

cemented acetabular component, 

prosthesis; and hip joint metal/metal 

semi-constrained, with an uncemented 

acetabular component, prosthesis. 

DATES: This order is effective on 

February 18, 2016. 

FOR FURTHER INFORMATION CONTACT: 

Sergio M. de del Castillo, Center for 

Devices and Radiological Health, 10903 

New Hampshire Ave., Bldg. 66, Rm. 

1538, Silver Spring, MD 20993, 301– 

796–6419. 

SUPPLEMENTARY INFORMATION: 

I. Background—Regulatory Authorities 

The Federal Food, Drug, and Cosmetic 

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

Medical Device Amendments of 1976 

(the 1976 amendments) (Pub. L. 94– 

295), the Safe Medical Devices Act of 

1990 (Pub. L. 101–629), the Food and 

Drug Administration Modernization Act 

of 1997 (Pub. L. 105–115), the Medical 

Device User Fee and Modernization Act 

of 2002 (Pub. L. 107–250), the Medical 

Devices Technical Corrections Act (Pub. 

L. 108–214), the Food and Drug 

Administration Amendments Act of 

2007 (Pub. L. 110–85), and the Food and 

Drug Administration Safety and 

Innovation Act (FDASIA) (Pub. L. 112– 

144), among other amendments, 

established 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). 

Under section 513(d) of the FD&C Act, 

devices that were in commercial 

distribution before the enactment of the 

1976 amendments, May 28, 1976 

(generally referred to as preamendments 

devices), are classified after FDA has: (1) 

Received a recommendation from a 

device classification panel (an FDA 

advisory committee); (2) published the 

panel’s recommendation for comment, 

along with a proposed regulation 

classifying the device; and (3) published 

a final regulation classifying the device. 

FDA has classified most 

preamendments devices under these 

procedures. 

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) 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 preamendments device that has 

been classified into class III and devices 

found substantially equivalent by means 

of premarket notification (510(k)) 

procedures to such a preamendments 

device or to a device within that type 

(both the preamendments and 

substantially equivalent devices are 

referred to as preamendments class III 

devices) may be marketed without 

submission of a PMA until FDA issues 

a final order under section 515(b) of the 

FD&C Act (21 U.S.C. 360e(b)) requiring 

premarket approval. Section 515(b)(1) of 

the FD&C Act directs FDA to issue an 

order requiring premarket approval for a 

preamendments class III device. 

Although, under the FD&C Act, the 

manufacturer of a preamendments class 

III device may respond to the call for 

PMAs by filing a PMA or a notice of 

completion of a PDP. In practice, the 

option of filing a notice of completion 

of a PDP has rarely been used. For 

simplicity, although the PDP option 

remains available to manufacturers in 

response to a final order under section 

515(b) of the FD&C Act, this document 

will refer only to the requirement for the 

filing of, and obtaining approval of, a 

PMA. 

On July 9, 2012, FDASIA was enacted. 

Section 608(a) of FDASIA amended 

section 513(e) of the FD&C Act, 

changing the process for reclassifying a 

device from rulemaking to an 

administrative order. Section 608(b) of 

FDASIA amended section 515(b) of the 

FD&C Act, changing the process for 

requiring premarket approval for a 

preamendments class III device from 

rulemaking to an administrative order. 

FDA is requiring PMAs for total 

metal-on-metal (MoM) semi-constrained 

hip joint systems (heretofore referenced 

as ‘‘MoM hips’’), which include the 

following two specific preamendments 

class III devices: Hip joint metal/metal 

semi-constrained, with a cemented 

acetabular component, prosthesis; and 

hip joint metal/metal semi-constrained, 

with an uncemented acetabular 

component, prosthesis. 

Section 515(b)(1) of the FD&C Act sets 

forth the process for issuing a final 

order. Specifically, prior to the issuance 

of a final order requiring premarket 

approval for a preamendments class III 

device, the following must occur: (1) 

Publication of a proposed order in the 

Federal Register; (2) a meeting of a 

device classification panel described in 

section 513(b) of the FD&C Act; and (3) 

consideration of comments from all 

affected stakeholders, including 

patients, payors, and providers. FDA 

published a proposed order to require 

PMAs for MoM hips in the Federal 

Register of January 18, 2013 (78 FR 

4094), and convened a meeting of a 

device classification panel for MoM 

hips as discussed in the proposed order 

and in this document. 

Section 515(b)(3) of the FD&C Act 

provides that FDA shall, after the close 

of the comment period on the proposed 

order, consideration of any comments 

received, and a meeting of a device 

classification panel described in section 

513(b) of the FD&C Act, issue a final 

order to require premarket approval or 

publish a document terminating the 

proceeding together with the reasons for 

such termination. 

A preamendments class III device 

may be commercially distributed 

without a PMA until 90 days after FDA 

issues a final order (a final rule issued 


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Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Rules and Regulations 8147 

under section 515(b) of the FD&C Act 

prior to the enactment of FDASIA is 

considered to be a final order for 

purposes of section 501(f) of the FD&C 

Act (21 U.S.C. 351(f))) requiring 

premarket approval for the device, or 30 

months after final classification of the 

device under section 513 of the FD&C 

Act, whichever is later. For MoM hips, 

the later of these two time periods is the 

90-day period. Therefore, section 

501(f)(2)(B) of the FD&C Act requires 

that a PMA for such devices be filed 

within 90 days of the date of issuance 

of this final order. If a PMA is not filed 

for such devices within 90 days after the 

issuance of this final order, the devices 

will be deemed adulterated under 

section 501(f) of the FD&C Act. 

Also, a preamendments device subject 

to the order process under section 

515(b) of the FD&C Act is not required 

to have an approved investigational 

device exemption (IDE) (see part 812 (21 

CFR part 812)) contemporaneous with 

its interstate distribution until the date 

identified by FDA in the final order, 

requiring the filing of a PMA for the 

device. At that time, an IDE is required 

only if a PMA has not been filed. If the 

manufacturer, importer, or other 

sponsor of the device submits an IDE 

application and FDA approves it, the 

device may be distributed for 

investigational use. If a PMA is not filed 

by the later of the two dates, and the 

device is not distributed for 

investigational use under an IDE, the 

device is deemed to be adulterated 

within the meaning of section 

501(f)(1)(A) of the FD&C Act, and 

subject to seizure and condemnation 

under section 304 of the FD&C Act (21 

U.S.C. 334), if its distribution continues. 

Other enforcement actions include, but 

are not limited to, the following: 

Shipment of devices in interstate 

commerce may be subject to injunction 

under section 302 of the FD&C Act (21 

U.S.C. 332), and the individuals 

responsible for such shipment may be 

subject to prosecution under section 303 

of the FD&C Act (21 U.S.C. 333). 

FDA held a meeting of a device 

classification panel described in section 

513(b) of the FD&C Act with respect to 

MoM hips on August 8, 2001, and 

therefore, has met this requirement 

under section 515(b)(1) of the FD&C Act. 

The panel recommended that the 

devices remain in class III because there 

was insufficient information to establish 

special controls; the panel also agreed 

unanimously that MoM hips are for a 

use which is of substantial importance 

in preventing impairment of human 

health (Ref. 1). FDA is not aware of new 

information that would provide a basis 

for a different recommendation or 

findings, and the recent reports and 

evaluations discussed in the proposed 

order further support that 

reclassification of MoM hips is not 

appropriate. Furthermore, the problems 

identified in the medical device 

reporting systems and recalls for MoM 

hips further indicate the need to review 

these devices under a PMA to provide 

reasonable assurance of their safety and 

effectiveness. 

FDA received and has considered 

several sets of comments from nine 

commenters on the proposed order, as 

discussed in section II. 

II. Public Comments in Response to the 

Proposed Order 

In response to the January 18, 2013 

(78 FR 4094), proposed order to require 

premarket approval for MoM hips, FDA 

received several sets of comments from 

nine commenters. These comments, as 

well as the Agency’s consideration of 

them, are summarized further in this 

section. 

Six commenters generally agreed with 

FDA’s proposal to require PMAs for 

MoM hips. One commenter (the 

American Academy of Orthopaedic 

Surgeons, also referred to as AAOS) 

stated that the existing data is not 

adequate to support reclassification of 

MoM hips because special controls 

could not be established to provide a 

reasonable assurance of device safety 

and effectiveness. This comment echoes 

the findings and recommendations of 

the August 8, 2001, panel. 

Another commenter stated that MoM 

hip resurfacing devices should be 

classified as Class III; however, MoM 

hip resurfacing devices are not regulated 

under 21 CFR 888.3320 or 21 CFR 

888.3330 and are not the subject of this 

order. 

Several commenters requested that all 

currently marketed MoM hips be 

removed from the market, either 

through a FDA-initiated recall or 

voluntary action by the device 

manufacturer. 

As explained in more detail in section 

III of this order, if a PMA for a currently 

marketed MoM hip is not filed on or 

before the 90th day past the effective 

date of this order, that device will be 

deemed adulterated under section 

501(f)(1)(A) of the FD&C Act, and 

commercial distribution of the device 

must cease immediately. FDA intends to 

take appropriate action to ensure 

compliance with the 90-day deadline for 

the submission of PMAs. The Agency 

believes this information adequately 

addresses the commenters’ concern. 

One commenter recommended 

standardizing the modularity and other 

design features of MoM hips to mitigate 

adverse events attributed to the 

manufacturing process for these devices. 

The Agency does not believe sufficient 

information exists to establish any 

manufacturing standards or specific 

technical specifications for MoM hips 

that could potentially be generalized for 

this technology to mitigate adverse 

events. 

One commenter requested that the 

Agency set revision surgery standards. 

Revision surgery involves a complex 

clinical decision that falls within the 

practice of medicine, which FDA 

generally does not regulate. In addition, 

insufficient information exists to 

establish any standards for revision 

surgery. FDA notes, however, that the 

American Association of Hip and Knee 

Surgeons, the American Academy of 

Orthopaedic Surgeons, and the Hip 

Society issued a consensus statement 

regarding assessment of risks in patients 

implanted with MoM hips, including 

factors to consider for revision surgery, 

based on currently available information 

(Ref. 2). FDA’s Web site for MoM hips 

also provides some general 

considerations regarding revision 

surgery (Ref. 3). 

One commenter requested that MoM 

hips not be used in women, including 

those of child-bearing age, and children 

who are still growing (i.e., skeletally 

immature). As noted in the proposed 

order and as presented during the June 

27–28, 2012, panel meeting, labeling for 

MoM hips includes warnings or 

contraindications for skeletally 

immature patients and patients who are 

pregnant or who may become pregnant 

(Ref. 4). In addition, the Agency will 

review all data included in the required 

PMA for a MoM hip to determine what 

information needs to be included in the 

device labeling to assure its safe and 

effective use, including any warnings 

and contraindications. The removal of 

any current contraindications for these 

patient populations would need to be 

supported by valid scientific evidence, 

in accordance with 21 CFR 860.7. 

One commenter requested the 

adoption of standards for metal ion 

levels in the serum of patients 

implanted with a MoM hip. As 

discussed in detail during the June 28, 

2012, panel meeting, there are 

challenges to implementing metal ion 

testing into clinical evaluations of 

patients treated with MoM hips, as well 

as challenges in the interpretation of 

metal ion testing results (Ref. 5). For 

example, the equipment and expertise 

required to conduct such testing are 

currently not widely available in health 

care facilities. In addition, there can be 

significant variability in test results, 

based on a number of factors, including 


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8148 Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Rules and Regulations 

the laboratory conducting the testing 

(inter-laboratory variability) and the 

specific MoM hip implanted in the 

patient. Further, insufficient 

information exists to establish a 

definitive correlation between metal ion 

levels and clinical outcomes. Therefore, 

the Agency does not believe such 

standards can be adequately developed 

at this time. Nonetheless, the Agency 

acknowledges the importance of using 

metal ion levels within the overall 

clinical assessment of patients 

implanted with MoM hips. On May 6, 

2011, under section 522 of the FD&C 

Act (21 U.S.C. 360l), FDA ordered 

manufacturers of MoM hips to conduct 

postmarket surveillance studies of these 

devices. As part of these studies, 

manufacturers are required to study the 

effects of metal ion concentrations in 

the bloodstream. The Agency will use 

the data from these studies to determine 

if any additional recommendations can 

be developed with respect to metal ion 

levels. 

One commenter stated that FDA 

should affirmatively assert that common 

law liability claims relating to MoM 

hips that are included under this final 

order, which were cleared through the 

510(k) process before the effective date 

of this final order, should not be 

preempted under section 521 of the 

FD&C Act (21 U.S.C. 360k). Section 521 

of the FD&C Act includes an express 

preemption provision that preempts 

certain state requirements that are 

‘‘different from, or in addition to’’ 

certain Federal requirements applicable 

to devices. Two Supreme Court cases: 

Medtronic, Inc. v. Lohr, 518 U.S. 470 

(1996) and Riegel v. Medtronic, Inc., 552 

U.S. 312 (2008), address the scope of 

this provision. In Lohr, the Court held 

that design defect, manufacturing, and 

failure to warn claims relating to a 

510(k)-cleared device were not 

preempted because there were no 

Federal ‘‘requirements’’ imposed by the 

510(k) review where (1) the device 

could ‘‘take any particular form for any 

particular reason,’’ and (2) the general 

Federal manufacturing and labeling 

requirements were not specific to the 

device in question. Id. at 493, 497–502. 

In contrast, the Court determined in 

Riegel that the PMA review imposed 

Federal ‘‘requirements’’ under section 

521 of the FD&C Act because FDA 

required that the PMA-approved device 

be made with almost no deviations from 

the specifications in the approved PMA. 

552 U.S. at 323. The Riegel Court went 

on to hold that the Riegels’ common law 

claims were preempted where New 

York law imposed requirements on the 

PMA-approved device that were 

‘‘different from, or in addition to’’ the 

Federal requirements. Id. at 327–330. As 

seen in these cases, the preemption 

analysis under section 521 of the FD&C 

Act depends on whether 

‘‘requirements’’ imposed by State law 

are different from or in addition to 

‘‘requirements’’ imposed by Federal 

law. This determination involves 

resolution of a number of critical factual 

issues, including identifying the 

applicable State and Federal (if any) 

requirements that relate to the claims 

asserted, defining the scope of those 

requirements, and evaluating their 

relationship to one another. Although 

Lohr may be relevant to the situation 

described in the comment, FDA notes 

that the inquiry into preemption needs 

to consider the context and all relevant 

facts. The situation described in the 

comment is fairly generalized, and as 

such, FDA believes it would not be 

helpful to opine on this issue at this 

point in time. 

Finally, several comments 

recommended actions that address 

broader issues or programmatic areas, 

such as changes to the postmarket 

surveillance process for all class III 

medical devices, recommendations for 

research studies, and the establishment 

of a ‘‘trust fund’’ for healthcare 

reimbursement of failed MoM hips. 

These requests are outside the scope of 

the regulatory actions described in this 

order. 

III. The Final Order 

Under section 515(b)(3) of the FD&C 

Act, FDA is adopting its findings as 

published in the proposed order (78 FR 

4094), and is issuing this final order to 

require the filing of a PMA for MoM 

hips, which specifically includes the 

following two device types: Hip joint 

metal/metal semi-constrained, with a 

cemented acetabular component, 

prosthesis; and hip joint metal/metal 

semi-constrained, with an uncemented 

acetabular component, prosthesis. This 

final order will revise 21 CFR part 888. 

Under the final order, a PMA is 

required to be filed on or before May 18, 

2016, for any of these preamendments 

class III devices that were in commercial 

distribution before May 28, 1976, or that 

has been found by FDA to be 

substantially equivalent to such a device 

on or before May 18, 2016. An applicant 

of a device subject to this order that was 

legally in commercial distribution 

before May 28, 1976, or that has been 

found to be substantially equivalent to 

a device that was legally in commercial 

distribution before May 28, 1976, may 

continue marketing such class III device 

during FDA’s review of the PMA 

provided that the PMA is filed on or 

before May 18, 2016. However, if FDA 

denies approval of the PMA, then the 

device will be deemed adulterated 

under section 501(f)(1)(A) of the FD&C 

Act, and commercial distribution of the 

device must cease immediately. Any 

other device subject to this order is 

required to have an approved PMA in 

effect before it may be marketed. FDA 

intends to review any PMA for the 

device within 180 days, and any notice 

of completion of a PDP for the device 

within 90 days of the date of filing. FDA 

cautions that under section 

515(d)(1)(B)(i) of the FD&C Act, the 

Agency may not enter into an agreement 

to extend the review period for a PMA 

beyond 180 days unless the Agency 

finds that ‘‘the continued availability of 

the device is necessary for the public 

health.’’ 

If a PMA for any of the 

preamendments class III devices subject 

to this order is not filed on or before 

May 18, 2016, that device will be 

deemed adulterated under section 

501(f)(1)(A) of the FD&C Act, and 

commercial distribution of the device 

must cease immediately. FDA requests 

that manufacturers take action to 

prevent the further use of MoM hips for 

which no PMA has been filed. 

The device may, however, be 

distributed for investigational use, if the 

applicable requirements of the IDE 

regulations (part 812), including 

obtaining IDE approval, are met on or 

before 90 days after the effective date of 

this order. There will be no extended 

period for filing an IDE or exemption 

from the IDE requirements (see 

§ 812.2(d)), and clinical studies may not 

be initiated without appropriate IDE 

approvals, as required. 

IV. 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. 

V. Paperwork Reduction Act of 1995 

This final order refers to previously 

approved collections of information 

found in 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 

21 CFR part 812 have been approved 

under OMB control number 0910–0078; 

the collections of information in 21 CFR 

part 807, subpart E, have been approved 

under OMB control number 0910–0120; 


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Federal Register / Vol. 81, No. 32 / Thursday, February 18, 2016 / Rules and Regulations 8149 

the collections of information in 21 CFR 

part 814, subpart B, have been approved 

under OMB control number 0910–0231; 

and the collections of information under 

21 CFR part 801 have been approved 

under OMB control number 0910–0485. 

VI. Codification of Orders 

Prior to the amendments by FDASIA, 

section 515(b) of the FD&C Act provided 

for FDA to issue regulations to require 

approval of an application for premarket 

approval for preamendments devices or 

devices found substantially equivalent 

to preamendments devices. Section 

515(b) of the FD&C Act, as amended by 

FDASIA, provides for FDA to require 

approval of an application for premarket 

approval for such devices by issuing a 

final order following the issuance of a 

proposed order in the Federal Register. 

FDA will continue to codify the 

requirement for an application for 

premarket approval in the Code of 

Federal Regulations (CFR). Therefore, 

under section 515(b)(1) of the FD&C Act, 

as amended by FDASIA, in this final 

order, FDA is requiring approval of an 

application for premarket approval for 

total MoM semi-constrained hip joint 

systems, which include the following 

two specific preamendments class III 

devices: Hip joint metal/metal semiconstrained, with a cemented acetabular 

component, prosthesis; and hip joint 

metal/metal semi-constrained, with an 

uncemented acetabular component, 

prosthesis; and the Agency is making 

the language in 21 CFR 888.3320 and 

888.3330 consistent with this final 

order. 

VII. References 

The following references are on 

display in the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852, 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 http://

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, Orthopaedic and Rehabilitation 

Devices Panel transcript, August 8, 2001. 

Available at http://www.fda.gov/ohrms/

dockets/ac/01/transcripts/3780t1.rtf. 

2. Kwon et al. ‘‘Risk Stratification Algorithm 

for Management of Patients with Metalon-Metal Hip Arthroplasty.’’ Journal of 

Bone and Joint Surgery, American 

Volume, 96:e4, 2014. 

3. FDA, Metal-on-Metal Hip Implants Web 

site, Information for Orthopaedic 

Surgeons. Available at http://

www.fda.gov/MedicalDevices/

ProductsandMedicalProcedures/

ImplantsandProsthetics/MetalonMetal

HipImplants/ucm241667.htm. 

4. FDA, Orthopaedic and Rehabilitation 

Devices Panel, FDA Executive Summary, 

June 27–28, 2012. Available at http://

www.fda.gov/downloads/

AdvisoryCommittees/Committees

MeetingMaterials/MedicalDevices/

MedicalDevicesAdvisoryCommittee/

OrthopaedicandRehabilitationDevices

Panel/UCM309302.pdf. 

5. FDA, Orthopaedic and Rehabilitation 

Devices Panel transcript, June 28, 2012. 

Available at http://www.fda.gov/

downloads/AdvisoryCommittees/

CommitteesMeetingMaterials/

MedicalDevices/

MedicalDevicesAdvisoryCommittee/

OrthopaedicandRehabilitationDevices

Panel/UCM313605.pdf. 

List of Subjects in 21 CFR Part 888 

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 888 is 

amended as follows: 

PART 888—ORTHOPEDIC DEVICES 

■ 1. The authority citation for 21 CFR 

part 888 continues to read as follows: 

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

360j, 371. 

■ 2. Section 888.3320 is amended by 

revising paragraph (c) to read as follows: 

§ 888.3320 Hip joint metal/metal semiconstrained, with a cemented acetabular 

component, prosthesis. 

* * * * * 

(c) Date PMA or notice of completion 

of PDP is required. A PMA or a notice 

of completion of a PDP is required to be 

filed with the Food and Drug 

Administration on or before May 18, 

2016, for any hip joint metal/metal 

semi-constrained prosthesis with a 

cemented acetabular component that 

was in commercial distribution before 

May 28, 1976, or that has, on or before 

May 18, 2016, been found to be 

substantially equivalent to a hip joint 

metal/metal semi-constrained prosthesis 

with a cemented acetabular component 

that was in commercial distribution 

before May 28, 1976. Any other hip joint 

metal/metal semi-constrained prosthesis 

with a cemented acetabular component 

shall have an approved PMA or a 

declared completed PDP in effect before 

being placed in commercial 

distribution. 

■ 3. Section 888.3330 is amended by 

revising paragraph (c) to read as follows: 

§ 888.3330 Hip joint metal/metal semiconstrained, with an uncemented 

acetabular component, prosthesis. 

* * * * * 

(c) Date PMA or notice of completion 

of PDP is required. A PMA or a notice 

of completion of a PDP is required to be 

filed with the Food and Drug 

Administration on or before May 18, 

2016, for any hip joint metal/metal 

semi-constrained prosthesis with an 

uncemented acetabular component that 

was in commercial distribution before 

May 28, 1976, or that has, on or before 

May 18, 2016, been found to be 

substantially equivalent to a hip joint 

metal/metal semi-constrained prosthesis 

with an uncemented acetabular 

component that was in commercial 

distribution before May 28, 1976. Any 

other hip joint metal/metal semiconstrained prosthesis with an 

uncemented acetabular component shall 

have an approved PMA or a declared 

completed PDP in effect before being 

placed in commercial distribution. 

Dated: February 11, 2016. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2016–03331 Filed 2–17–16; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[TD 9750] 

RIN 1545–BM59 

Reporting of Original Issue Discount 

on Tax-Exempt Obligations; Basis and 

Transfer Reporting by Securities 

Brokers for Debt Instruments and 

Options 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Final regulations. 

SUMMARY: This document contains final 

regulations relating to information 

reporting by brokers for transactions 

involving debt instruments and options, 

including the reporting of original issue 

discount (OID) on tax-exempt 

obligations, the treatment of certain 

holder elections for reporting a 

taxpayer’s adjusted basis in a debt 

instrument, and transfer reporting for 

section 1256 options and debt 

instruments. The regulations in this 

document provide guidance to brokers 

and payors and to their customers. 

DATES:

Effective date: These regulations are 

effective on February 18, 2016. 


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