[Federal Register Volume 80, Number 195 (Thursday, October 8, 2015)]
[Proposed Rules]
[Pages 60809-60817]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25627]


 ========================================================================
 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 80, No. 195 / Thursday, October 8, 2015 / 
Proposed Rules  

[[Page 60809]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 880

[Docket No. FDA-2015-N-0701]


General Hospital and Personal Use Devices: Renaming of Pediatric 
Hospital Bed Classification and Designation of Special Controls for 
Pediatric Medical Crib; Classification of Medical Bassinet

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is proposing to rename 
pediatric hospital beds as pediatric medical cribs and establish 
special controls for these devices. FDA is also proposing to establish 
a separate classification regulation for medical bassinets, previously 
under the pediatric hospital bed classification regulation, as a class 
II (special controls) device. The proposed regulation for both 
pediatric medical cribs and medical bassinets would also include the 
Consumer Product Safety Commission's (CPSC) mattress flammability 
standards for the mattresses intended for use with these devices. In 
addition, this proposed rule would require prescription use of 
pediatric medical cribs and bassinets.

DATES: Submit either electronic or written comments by December 7, 
2015. See section VII of this document for the proposed effective date 
of a final rule based on this proposed rule.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2015-N-0701 for ``General Hospital and Personal Use Devices: 
Renaming of Pediatric Hospital Bed Classification and Designation of 
Special Controls for Pediatric Medical Crib; Classification of Medical 
Bassinet.'' Received comments will be placed in the docket and, except 
for those submitted as ``Confidential Submissions,'' publicly viewable 
at http://www.regulations.gov or at the Division of Dockets Management 
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 http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Michael J. Ryan, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1615, Silver Spring, MD 20993-0002, 301-
796-6283.

SUPPLEMENTARY INFORMATION: 

I. Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 
301 et seq.), as amended by the Medical Device Amendments of 1976 (the 
1976 amendments) (Pub. L. 94-295), the Safe Medical Device Amendments 
of 1990 (SMDA) (Pub. L. 101-629), the Food and Drug Administration 
Modernization Act of 1997 (Pub. L. 105-115), the Food and Drug 
Administration Amendments Act of 2007 (Pub. L. 110-85), and the FDA 
Safety and Innovation Act (Pub. L. 112-

[[Page 60810]]

144), among other amendments, 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) establishes three categories (classes) 
of devices, based on 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).
    Most generic types of devices that were on the market before May 
28, 1976, the date of the 1976 amendments (generally referred to as 
preamendments devices), have been classified by FDA through the 
issuance of regulations in accordance with the procedures set forth in 
section 513(c) and (d) of the FD&C Act into one of these three 
regulatory classes. Devices introduced into interstate commerce for the 
first time on or after May 28, 1976 (generally referred to as post-
amendments devices), are classified automatically by statute (section 
513(f) of the FD&C Act) into class III without any FDA rulemaking 
process. These devices remain in class III and require premarket 
approval, unless FDA initiates one of the following procedures: (1) FDA 
reclassifies the device into class I or II; (2) FDA issues an order 
classifying the device into class I or II in accordance with section 
513(f)(2) of the FD&C Act; or (3) FDA issues an order finding the 
device to be substantially equivalent, under section 513(i), to a 
predicate device that is already legally marketed. The Agency 
determines whether new devices are substantially equivalent to 
predicate devices through review of premarket notifications under 
section 510(k) of the FD&C Act (21 U.S.C. 360(k)). Section 510(k) of 
the FD&C Act and its implementing regulations, codified in Title 21 of 
the Code of Federal Regulations (21 CFR part 807, subpart E), require 
persons who intend to market a new device that does not require a 
premarket approval application under section 515 of the FD&C Act (21 
U.S.C. 360e) to submit a premarket notification report (510(k)) 
containing information that allows FDA to determine whether the new 
device is ``substantially equivalent'' within the meaning of section 
513(i) of the FD&C Act to a legally marketed device that does not 
require premarket approval.
    Section 513(a)(1)(B) of the FD&C Act defines class II devices as 
those devices for which the general controls in section 513(a)(1)(A) by 
themselves are insufficient to provide reasonable assurance of safety 
and effectiveness, but for which there is sufficient information to 
establish special controls to provide such assurance, including the 
issuance of performance standards, postmarket surveillance, patient 
registries, development and dissemination of guidelines, 
recommendations, and any other appropriate actions the Agency deems 
necessary to provide such assurance (see also 21 CFR 860.3(c)(2)).
    Section 510(m)(2) of the FD&C Act provides that FDA may exempt a 
class II device from the premarket notification requirements on its own 
initiative or upon petition of an interested person, if FDA determines 
that a 510(k) is not necessary to provide reasonable assurance of the 
safety and effectiveness of the device. Devices under the pediatric 
hospital bed classification regulation were exempted from premarket 
notification, subject to certain limitations, in accordance with 
section 510(m) of the FD&C Act (63 FR 59222 at 59229, November 3, 
1998).

II. Regulatory History and Description of the Devices

    FDA classified pediatric hospital beds (21 CFR 880.5140) as class 
II devices (45 FR 69678 at 69694, October 21, 1980), and later exempted 
them from premarket notification (510(k)), in a final rule published in 
the Federal Register of November 3, 1998 (63 FR 59222 at 59229). In 
Sec.  880.5140, a pediatric hospital bed is defined as ``a device 
intended for medical purposes that consists of a bed or crib designed 
for the use of a pediatric patient, with fixed end rails and movable 
and latchable side rails. The contour of the bed surface may be 
adjustable.''
    A medical bassinet is a non-powered device that consists of two 
components: (1) A basket, the sleep or bed component, which is 
typically made of plastic and (2) a durable frame with wheels, which 
holds the basket or bed component (FDA refers to this component as a 
``basket or bed component'' in this proposed rule). The basket or bed 
component is a box-like structure, generally made of a clear, high-
impact resistant plastic material, with an open top and four stationary 
walls to keep the baby in place. Medical bassinets are typically used 
in hospital settings for infants up to 5 months in age. Medical 
bassinets currently fall under the pediatric hospital bed 
classification regulation.

III. Proposed Regulation

    Pediatric medical cribs that meet the definition of a device in 
section 201(h) of the FD&C Act (21 U.S.C. 321(h)) are regulated by FDA 
(referred to as pediatric medical cribs or cribs intended for medical 
purposes) (product code FMS) and, if this rule is finalized, will have 
to comply with the special controls identified in the final regulation 
for pediatric medical cribs. Cribs outside of the device definition 
(referred to as cribs for non-medical purposes) must meet the CPSC's 
regulations and guidelines. A crib designed for the use of a pediatric 
patient may meet the medical device definition if it is intended for 
use in the cure, mitigation or treatment of disease (see section 201(h) 
of the FD&C Act).
    In the Federal Register of December 28, 2010 (75 FR 81766), the 
CPSC issued a final rule prohibiting the use of the drop-side rail 
design for non-medical cribs in consumer households as of June 28, 
2011. Child care facilities, family child care homes, and places of 
public accommodation (e.g., hotels and motels) had to comply with the 
rule as of December 28, 2012. CPSC's rule establishes new standards for 
full-size and non-full-size cribs used for non-medical purposes, which 
effectively prohibit the manufacture or sale of cribs for non-medical 
purposes with a drop-side rail design in households, child care 
facilities, family child care homes, and places of public 
accommodation. This rule did not affect pediatric medical cribs 
regulated by FDA, which may contain a drop-side rail design that 
includes movable and latchable side and end rails.
    Because drop-side rail cribs for non-medical purposes and pediatric 
medical cribs are regulated by different agencies, CPSC consulted with 
FDA about the impact their final rule could have on settings, such as 
nursery schools and day care centers, where pediatric medical cribs 
with drop-side rails are often used for pediatric patients after they 
have been discharged from a health care facility. CPSC, which regulates 
consumer products, including drop-side rail cribs not intended for 
medical purposes, received reports of deaths of children attributable 
to entrapment and/or strangulation caused by the malfunctioning of 
drop-side rail cribs.
    Although drop-side cribs for non-medical purposes are now 
prohibited, there is still a need for pediatric medical cribs with 
drop-side rails inside and outside of traditional health care settings. 
CPSC and FDA have heard from medical device consumers and health care 
providers that pediatric medical cribs with drop-side rails are 
extremely helpful for patient care in hospital settings and even 
outside of traditional health care settings, such as day care centers 
caring for infants and children with disabilities, because they allow 
parents and care givers easy

[[Page 60811]]

access to children to perform routine and emergency medical procedures, 
including, but not limited to, CPR, blood collection, IV insertion, 
respiratory care, and skin care. These drop-side rail cribs also make 
it easier for hospital staff to facilitate safe patient transport and 
reduce the chance of caregiver injury. Health care workers have stated 
that they need to have continued access to these medical cribs with 
drop-side rails (Ref. 1). Therefore, FDA is proposing to permit 
manufacturers to continue to manufacture and sell medical cribs with 
the drop-side rail design in traditional health care settings and to 
permit the use of pediatric medical cribs with drop-side rail designs 
outside of traditional health care settings through prescription use 
only (it is noted that State child care licensing agencies are 
generally responsible for overseeing day care providers while FDA is 
responsible for medical devices).
    FDA is proposing to revise the identification in Sec.  880.5140 to 
include only pediatric medical cribs, establish special controls for 
this device, and change the name of the classification regulation from 
``pediatric hospital bed'' to ``pediatric medical crib.'' The Agency is 
taking these actions to clarify the devices that fall under this 
particular classification regulation and establish special controls the 
Agency believes are necessary for a reasonable assurance of safety and 
effectiveness. In addition, FDA is proposing that use of a pediatric 
medical crib be restricted to prescription use in accordance with 21 
CFR 801.109. In order to use or administer use of pediatric medical 
cribs, authorization must be made by a practitioner licensed by law 
through a prescription for the device.
    This rule also proposes to create a separate regulation for medical 
bassinets and establish special controls for this device type to 
provide a reasonable assurance of safety and effectiveness. In 
addition, FDA is proposing that use of medical bassinets be restricted 
to prescription use in accordance with 21 CFR 801.109. In order to use 
or administer use of medical bassinets, authorization must be made by a 
practitioner licensed by law through a prescription for the device. FDA 
proposes not to change the 510(k) exempt status of pediatric medical 
cribs and medical bassinets.
    Devices currently under the pediatric hospital bed classification 
regulation include: Open pediatric medical cribs, medical bassinets, 
pediatric cribs with integrated air mattresses, youth beds, pediatric 
stretchers, crib enclosure beds, and cuddle-carrier infant beds. If 
this proposed rule is finalized, devices that do not meet the 
definition of ``pediatric medical crib'' will be administratively moved 
to more appropriate class II regulations, and no longer be under the 
revised pediatric hospital bed classification regulation. At that time, 
FDA proposes to send manufacturers of the remaining pediatric hospital 
beds notices identifying the new classification regulation and product 
code under which the device will be classified.
    If this proposed rule is finalized, FDA intends to move the 
following medical devices listed under Sec.  880.5140 to devices with 
similar intended uses and class II regulations: Pediatric cribs with 
integrated air mattresses to 21 CFR 890.5170, ``Powered flotation 
therapy bed;'' youth beds to either 21 CFR 880.5100, ``AC powered 
adjustable hospital bed,'' or 21 CFR 880.5120, ``Manual adjustable 
hospital bed,'' depending on whether they are powered or not; pediatric 
stretchers to 21 CFR 880.6910, ``Wheeled stretchers;'' and crib 
enclosure beds to 21 CFR 880.6760, ``Protective restraint.'' This 
action would not have any substantive effect on the current marketing 
status of the devices. However, manufacturers of these devices would 
need to refer to the new regulation classification and product code 
provided by the Agency in future interactions with FDA.
    As discussed in section IV, an analysis of Medical Device Reports 
(MDRs) submitted to the Manufacturer and User Facility Device 
Experience (MAUDE) database from January 1, 2005, to September 1, 2015, 
indicated 516 adverse events associated with pediatric medical cribs 
including 15 serious injuries. The adverse events associated with 
pediatric medical cribs were assessed to better understand the risks 
and establish the proposed special controls for this device. FDA 
believes that sufficient information is available to establish special 
controls to provide a reasonable assurance of the safety and 
effectiveness of the device.
    As discussed further in section VI, FDA believes risks to health 
resulting from use of these cribs would be effectively mitigated by the 
special controls proposed in this rule, and that these controls, in 
combination with the general controls, would provide a reasonable 
assurance of safety and effectiveness for pediatric medical cribs for 
their intended use. Therefore, FDA is proposing new safety requirements 
and allowing medical cribs in homes and day cares only when medically 
necessary.
    FDA is also taking this opportunity to address adverse event 
reports pertaining to medical bassinets by proposing to establish 
special controls for these devices to provide a reasonable assurance of 
safety and effectiveness. FDA has received adverse events from 
hospitals regarding incidents of medical bassinet tipping and improper 
cleaning of the basket or bed component that caused cracks and crazing, 
which have resulted in patient injury. The Agency is proposing to 
separate medical bassinets from other types of pediatric hospital beds 
to allow for more targeted postmarket surveillance of these devices. 
FDA believes the special controls it is proposing here, in combination 
with the general controls, would provide a reasonable assurance of 
safety and effectiveness for medical bassinets.

IV. Risks to Health

A. Pediatric Medical Crib

    Between January 1, 2005, and September 1, 2015, FDA received 516 
adverse event reports, or MDRs, associated with open pediatric medical 
cribs, through the Agency's MAUDE database. There were 15 adverse event 
reports of serious injuries including 6 reports of entrapment, which 
were predominantly extremity entrapments of legs or arms. The majority 
of MDRs for medical cribs were for malfunctions such as drop-side rails 
not latching or lowering, brakes not holding, wheels or casters 
breaking, and where applicable, scales not reading correct weights. 
These malfunctions (501 reports) were not associated with any adverse 
health effects. After considering available information, FDA determined 
that the following risks to health are associated with the use of 
pediatric medical cribs:
     Injury resulting from mechanical or structural failure of 
the device--Mechanical or structural failure of the crib can result in 
failure of load-bearing components such as the wheels or casters, or 
failure of the latches or other locking mechanisms that secure the 
sides of the crib. These failures can result in injuries, as 
demonstrated by the MDRs received in FDA's database.
     Pinching, laceration, splinters, and foreign body 
ingestion--Depending on the material of the pediatric crib, certain 
cribs may peel or crack and may expose pediatric patients to substances 
or materials that may be toxic or may cause abrasions or lacerations if 
the surface of the crib material is compromised.
     Entrapment, falls, and strangulation--Pediatric medical 
cribs may cause entrapment of patient limbs if the width of the side 
rails are not correct and if there are gaps between the mattress and 
crib frame that are larger

[[Page 60812]]

than the width of two fingers. Depending on the height requirements of 
the rails a pediatric patient may escape or fall from the crib. The 
term ``entrapment'' refers to circumstances where a patient is caught, 
trapped, or entangled in the space in or about the bed rail, mattress, 
or hospital bed frame.
     Burns--Certain flammable materials used in the 
construction of pediatric medical cribs may allow for the spread of 
fire, which may result in serious injuries. Fires can spread easily in 
hospital rooms with a patient using oxygen. The free-flowing oxygen can 
intensify a fire, which can rapidly spread to flammable objects in the 
room, including crib mattresses.
     Use error--Use error may contribute to or exacerbate any 
of the previously mentioned adverse events. For example, a user may be 
unaware that a side rail did not latch, or may fail to properly 
maintain a pediatric medical crib. Therefore, adequate instructions for 
use and user education are essential to safe device operation.

B. Medical Bassinet

    Between January 1, 2005, and September 1, 2015, FDA received 40 
adverse event reports associated with this device type. The most common 
MDRs for medical bassinets include reports of malfunctions such as 
casters or wheels not working, which have caused tipping, and broken 
bassinet base components, such as doors and drawers, or collapse or 
breakage of utility shelves or chart holders. There are also reports of 
the plastic sleep basket or bed component crazing (cracking), resulting 
in sharp edges and cuts to hospital personnel.
    FDA has considered the available information and determined that 
the following risks to health are associated with medical bassinets:
     Injury resulting from mechanical or structural failure of 
the device--Mechanical or structural failure of the bassinet can result 
in failure of load-bearing components such as the wheels or casters, or 
failure of the latches or other locking mechanisms that secure the 
drawers of the bassinet. These failures can result in injuries, 
particularly if the bassinet tips over, as demonstrated by the MDRs 
received in FDA's database.
     Burns--Certain flammable materials used in the 
construction of pediatric medical bassinets may allow for the spread of 
fire, which may result in serious injuries. Fires can spread easily in 
hospital rooms with a patient using oxygen. The free-flowing oxygen can 
intensify a fire, which can rapidly spread to flammable objects in the 
room, including bassinet mattresses.
     Crazing or cracking of basket or bed component--The basket 
or bed component of the bassinet that the pediatric patient is placed 
in may craze or crack due to improper care or handling, such as 
cleaning the plastic material of the basket or bed component with 
inappropriate cleaning solutions. Crazing or cracking may result in 
injuries such as cuts.
     Use error--Use error may contribute to, or exacerbate, any 
of the previously mentioned risks. For example, a user may accidentally 
leave a door or drawer in the base component of the bassinet open or 
place too much weight in a drawer or on a shelf, which may present a 
tipping hazard. Also, a user may fail to properly maintain a medical 
bassinet.

V. Establishment of Special Controls

    Under section 513(a)(1)(B) of the FD&C Act, as amended by the SMDA, 
class II devices are defined as devices for which general controls by 
themselves are insufficient to provide reasonable assurance of safety 
and effectiveness, but for which there is sufficient information to 
establish special controls to provide such assurance. Special controls 
may include the issuance of performance standards, postmarket 
surveillance, patient registries, development and dissemination of 
guidelines, recommendations, and other appropriate actions the Agency 
deems necessary to provide such assurance (see also Sec.  860.3(c)(2)).
    Under this authority, FDA is proposing to establish special 
controls for pediatric medical cribs (Sec.  880.5140) and pediatric 
medical bassinets (Sec.  880. 5145). The Agency believes that the 
applicable special controls, together with the general controls, would 
provide reasonable assurance of the safety and effectiveness of these 
devices.

VI. Proposed Special Controls

A. Pediatric Medical Crib

    FDA consulted with health care providers in children's hospitals, 
registered nurses in pediatric units, biomedical engineers, and 
technicians, and analyzed the associated adverse events with pediatric 
medical cribs. Specifically, FDA consulted with MedSun hospitals 
regarding their 2011 survey on clinicians' experiences with pediatric 
medical cribs with drop-side rails used in MedSun's hospitals (Ref. 1). 
The MedSun survey summary highlights the clinical perspective and the 
importance of this device in medical and health care settings. The most 
common issues and concerns in the survey were the lack of understanding 
of side rail operation and the need for reinforcing patient safety when 
the side rails are raised or lowered. Many respondents of the survey 
suggested further improvements for pediatric medical cribs, for 
instance, improved labeling, specific distance between slats and 
emergency releases on side rails for faster access to pediatric 
patients. The adverse events identified in the MedSun survey are 
similar to the MDRs FDA has received on this device. FDA believes that 
the special controls proposed in this proposed rule, in combination 
with the general controls, would provide a reasonable assurance of 
safety and effectiveness for pediatric medical cribs their intended 
use.

Table 1--Health Risks and Mitigation Measures for Pediatric Medical Crib
------------------------------------------------------------------------
       Identified risks to health              Mitigation measures
------------------------------------------------------------------------
Injury Resulting from Mechanical or      Performance Testing.
 Structural Failure of the Device.       Design Testing.
Pinching, Lacerations, Splinters, and    Appropriate Materials Free From
 Foreign Body Ingestion.                  Surface Defects.
                                         Labeling.
Entrapment, Falls, and Strangulation...  Performance Testing.
                                         Rail and End Panel Design.
                                         Side Rail Spacing and Safety
                                          Features.
                                         Appropriate Fitting of
                                          Mattress.
Burns..................................  CPSC's Mattress Flammability
                                          Standard.
Use Error..............................  Labeling.
------------------------------------------------------------------------


[[Page 60813]]

    As provided in Table 1, the Agency believes the following special 
controls, in combination with the general controls, would effectively 
mitigate the identified risks to health and provide reasonable 
assurance of the safety and effectiveness of the device:
    1. Design and performance testing must be conducted to ensure the 
mechanical and structural stability of the crib under expected 
conditions of use, including the security of latches and other locking 
mechanisms when engaged. These requirements are derived from sections 
6.2 and 6.3 of ASTM (formerly the American Society for Testing and 
Materials) International Standard F1169-13, entitled ``Standard 
Consumer Safety Specification for Full-Size Baby Cribs'' (Ref. 2) and 
sections 5.7 and 6.3 of ASTM International Standard F2710-13, entitled 
``Standard Consumer Safety Performance Specification for Commercial 
Cribs'' (Ref. 3), which was developed with input from crib 
manufacturers.
    2. To reduce possible injury of pinching, lacerations, and 
crushing, the crib shall be designed and constructed in a manner that 
eliminates hardware accessible to a child within the crib. This 
requirement is derived from section 5.10 of ASTM International Standard 
F1169-13, entitled ``Standard Consumer Safety Specification for Full-
Size Baby Cribs'' (Ref. 2), which was developed with input from crib 
manufacturers. Also, materials used shall be appropriate for the 
conditions of use, allow for proper sanitation, and free from surface 
defects of the device that could result in injuries.
    3. To reduce the risk of head and limb entrapment, the distance 
between side rail components (such as slats, spindles, corner posts, 
and rods) shall be designed to reduce potential entrapment of pediatric 
patients and the distance between such components shall not exceed 2\3/
8\ inches (6 centimeters) apart. In addition, the rails and end panels 
of a crib must be of a height to mitigate the possibility of falls and/
or escapes by the patient. These requirements are derived from sections 
5.7.2 and 5.8.1 of ASTM International Standard F1169-13, entitled 
``Standard Consumer Safety Specification for Full-Size Baby Cribs'' 
(Ref. 2), which was developed with input from crib manufacturers.
    4. To reduce the risk of head and limb entrapment, no gap shall 
exist between the edge of the bottom rail and the top of the mattress 
surface and the mattress must fit tightly around all four sides of the 
crib. These requirements are derived from section 5.9 of ASTM 
International Standard F1169-13, entitled ``Standard Consumer Safety 
Specification for Full-Size Baby Cribs'' (Ref. 2), which was developed 
with input from crib manufacturers.
    5. To reduce flammability and the risk of burns, the mattress for 
the crib shall meet the CPSC Standard for the Flammability of 
Mattresses and Mattress Pads and its Standard for the Flammability 
(Open Flame) of Mattress Sets, 16 CFR parts 1632 and 1633, 
respectively. This proposed special control would clarify for 
manufacturers the standards necessary for mattresses intended to be 
used with pediatric medical cribs to prevent the spread of fires that 
can easily occur in hospital rooms with a patient using oxygen. The 
free-flowing oxygen can intensify a fire, which can rapidly spread to 
most of the flammable objects in the room especially mattresses. The 
consumer standards for flammability of mattresses in 16 CFR parts 1632 
and 1633 are also accepted by the Joint Commission (formerly the Joint 
Commission on Accreditation of Healthcare Organizations). CPSC's 
mattress and mattress pad flammability standard under 16 CFR part 1632 
addresses mattress fires ignited by open flame sources, including 
matches, candles, lighters, and other related scenarios. It prescribes 
a test to determine the ignition resistance of a mattress or a mattress 
pad when exposed to a lighted cigarette. CPSC's standard for the 
flammability of mattress sets under 16 CFR part 1633 is a broader 
standard designed to reduce deaths and injuries caused by mattress 
fires, particularly those fires ignited by, among others things, oxygen 
use or electrical equipment sources that may occur in a patient's room. 
In addition, CPSC's regulations require that manufacturers meet an 
established fire safety performance standard, based on ASTM E2187-09, 
entitled ``International's Standard Test Method for Measuring the 
Ignition Strength of Cigarettes'' (Ref. 4), which was developed with 
input from crib manufacturers.
    6. To reduce flammability and the risk of burns, the labeling must 
bear all information required pursuant to the CPSC Standard for the 
Flammability of Mattresses and Mattress Pads and its Standard for the 
Flammability (Open Flame) of Mattress Sets, 16 CFR parts 1632 and 1633, 
respectively.
    7. To reduce the risk of use error, which may result in mechanical 
or structural failure of the crib due to inadequate care or 
maintenance, pediatric medical crib labeling must include adequate 
instructions for users to care for and maintain their crib. These 
requirements are derived from sections 5.18 of ASTM International 
Standard F1169-13, entitled ``Standard Consumer Safety Specification 
for Full-Size Baby Cribs'' (Ref. 2).
    FDA believes that the special controls proposed in this rule would 
provide a reasonable assurance of safety and effectiveness of pediatric 
medical cribs in their intended use. The ASTM and CPSC standards noted 
above apply to all mattresses and mattress pads intended or promoted 
for sleeping upon, as defined in 16 CFR 1632.1(a), including medical 
mattresses that are regulated by FDA as an accessory to medical beds. 
Therefore, FDA anticipates that manufacturers would be able to meet the 
requirements imposed by the proposed special controls in this proposed 
rule without undue burden. FDA invites comments on this conclusion, 
including comments regarding the types of performance testing 
manufacturers conduct for pediatric medical cribs, particularly to 
ensure the performance of medical crib latches on drop-side rails.
    In addition, FDA is proposing to restrict these devices to 
prescription use under section 520(e) of the FD&C Act (see Sec.  
801.109 (prescription devices)). In order to use or administer use of 
pediatric medical cribs, authorization must be made by a practitioner 
licensed by law.

B. Medical Bassinet

    Table 2 lists the risks to health FDA has identified for Medical 
Bassinets, as described in the Risks to Health, section IV of this 
proposed rule, along with the corresponding proposed mitigation 
measures for each risk.

   Table 2--Health Risks and Mitigation Measures for Medical Bassinet
------------------------------------------------------------------------
       Identified risks to health              Mitigation measures
------------------------------------------------------------------------
Injury Resulting from Mechanical or      Performance Testing.
 Structural Failure of the Device.
                                         Labeling.
Burns..................................  CPSC's Mattress Flammability
                                          Standard.

[[Page 60814]]

 
Crazing or Cracking of Basket or Bed     Performance Testing.
 Component.
                                         Labeling.
Use Error..............................  Labeling.
------------------------------------------------------------------------

    The Agency believes the following special controls, in combination 
with the general controls, would effectively mitigate the identified 
risks to health and provide reasonable assurance of the safety and 
effectiveness of medical bassinets:
    1. To mitigate crazing, cracking, and deterioration of the basket 
or bed component of the device, the manufacturer must conduct 
performance testing to determine material compatibility with cleansing 
products labeled to clean the device.
    2. To reduce flammability and the risk of burns, the bassinet shall 
meet CPSC's Standard for the Flammability of Mattresses and Mattress 
Pads and its Standard for the Flammability (Open Flame) of Mattress 
Sets, 16 CFR parts 1632 and 1633, respectively.
    3. To reduce the risk of injury resulting from mechanical or 
structural failure of the device, and particularly, device tipping that 
can result from those failures; manufacturers shall conduct performance 
testing to ensure the mechanical and structural stability of the 
bassinet under expected use conditions, including transport of patients 
in the bassinet.
    4. To reduce the risk of use error, specifically error that may 
result in bassinet tipping, FDA proposes that manufacturers shall have 
a label on the front of the bassinet cabinet with the following warning 
statement:

    WARNING: To avoid tipping hazards of this device, make sure that 
the basket or bed component sits firmly in the base and that all 
doors, drawers, and casters are secure.

    The label must be affixed to the front of the bassinet base cabinet 
and the text shall be in letters not less than 10 millimeters in 
height.
    FDA believes this warning is necessary because even if performance 
testing demonstrates that a bassinet does not present a tipping hazard 
under expected use conditions, users may exceed these expected use 
conditions, particularly during transport of a patient in the bassinet.
    5. To reduce the risk of use error, which may result in mechanical 
or structural failure of the bassinet due to inadequate care or 
maintenance, medical bassinet labeling must include adequate 
instructions for users to care for and maintain the bassinet.
    FDA believes that the special controls proposed in this rule would 
provide a reasonable assurance of safety and effectiveness of medical 
bassinets in their intended use. The CPSC standards noted previously 
apply to all mattresses and mattress pads intended or promoted for 
sleeping upon, as defined in 16 CFR 1632.1(a), including medical 
mattresses that are regulated by FDA as an accessory to medical beds. 
Therefore, FDA believes most manufacturers are already complying with 
the proposed special control for mattress flammability set forth in 
this proposed rule. FDA invites comments on the types of performance 
testing manufacturers conduct for medical bassinets.
    In addition, FDA is proposing to restrict these devices to 
prescription use under section 520(e) of the FD&C Act (see Sec.  
801.109 (Prescription devices)). In order to use or administer use of 
medical bassinets, authorization must be made by a practitioner 
licensed by law.

VII. Proposed Effective Date

    FDA proposes that any final rule based on this proposal become 
effective 60 days after its publication in the Federal Register.

VIII. Environmental Impact, No Significant 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.

IX. Economic Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612) and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). The Agency believes that this proposed rule is not a 
significant regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because the expected costs associated with this rule 
are expected to be modest, we propose to certify that this rule would 
not have a significant economic impact on a substantial number of small 
entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that Agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $144 million, using the most current (2014) Implicit 
Price Deflator for the Gross Domestic Product. We do not expect this 
proposed rule to result in any 1-year expenditure that would meet or 
exceed this amount.

A. Objective of the Rule

    Pediatric hospital beds are classified as class II, 510(k) exempt 
medical devices intended for the treatment, care, or diagnosis of 
diseases or illnesses of pediatric patients. In this proposed rule, FDA 
proposes to amend Sec.  880.5140 by revising the identification and 
establishing special controls for pediatric medical cribs. This rule 
would also change the name of the classification regulation from 
``pediatric hospital bed'' to ``pediatric medical crib,'' and place 
medical bassinets, previously under the pediatric hospital beds 
classification regulation, as a separate class II, 510(k) exempt 
device, subject to its own special controls.
    Pediatric medical cribs used in health care settings contain a 
drop-side rail design that includes movable and latchable side and end 
rails. As stated previously, the CPSC issued a final rule prohibiting 
the use of the drop-side rail design for non-medical cribs in consumer 
households as of June 28,

[[Page 60815]]

2011 (December 28, 2010, 75 FR 81766). CPSC's rule establishes new 
standards for full-size and non-full-size cribs used for non-medical 
purposes, which effectively prohibit the manufacture or sale of cribs 
for non-medical purposes with a drop-side rail design in households, 
child care facilities, family child care homes, and places of public 
accommodation. The compliance date for this same rule for child care 
facilities, family child care homes, and places of public accommodation 
was December 28, 2012 (75 FR 81766). CPSC's rule was established in 
response to infant deaths that occurred when the side rail of a crib 
used for non-medical purposes detached or disengaged. In contrast, 
there have been no deaths and a few serious injuries reported to FDA 
associated with pediatric medical cribs, which are made of more durable 
materials and construction in comparison to cribs used for non-medical 
purposes. Additionally, FDA has determined that drop-side rails are 
essential for patient care in hospital settings and even outside of 
traditional health care settings to allow parents and care givers easy 
access to their patients in order to perform both routine and emergency 
medical procedures. To address concerns raised by CPSC's reports on 
consumer drop-side rail cribs and account for the medical need of this 
device, FDA is proposing to establish special controls and require a 
prescription for this device when used outside of traditional health 
care setting. Thus, FDA has determined that cribs with drop-side rail 
designs may remain on the market when intended for medical use, and can 
be used outside of traditional health care settings through 
prescription use only. In addition, this proposed rule adds specific 
special controls for medical bassinets to mitigate health risks such as 
tipping of the device and crazing of the plastic basket or bed 
component. Regulation of this device under a separate regulation would 
also allow for more targeted post market surveillance for this device.

B. Benefits

    FDA's Registration and Listing database identifies 38 manufacturers 
of medical cribs and bassinets. FDA has reviewed the safety standards 
of several large pediatric crib and bassinet manufacturers in order to 
determine the compliance burden associated with the proposed special 
controls. The Agency concludes that many of the special controls 
proposed by this rule are consistent with current industry practice 
among many medical crib and bassinet manufacturers. The proposed 
special control that is not currently practiced is the warning labeling 
requirements for medical bassinets. For new pediatric medical crib and 
bassinet manufacturers entering the market or manufacturers that may 
not be currently following the practices required by the proposed 
special controls, if this proposed rule is finalized, its special 
controls will clarify safety standards and minimize the risk of injury 
to pediatric patients.
    The beneficial features of medical bassinets are portability, ease 
of cleaning, and, when it is made of a clear material, the ability to 
see the baby from all sides. The proposed special controls would 
require bassinet manufacturers to place labels on their devices warning 
against device tipping. This requirement would apply to new bassinets; 
bassinets that have already been sold would not be required to add the 
new labels to their devices. The warning label is intended to prevent 
tipping of the device, which may be caused by unlatched drawers, 
dislodged wheels, or too much weight on the shelves. The Agency has not 
received any reports of death or serious injury related to medical 
bassinets, although there have been a small number of reports of 
malfunctioning casters, which may cause device tipping. The benefits of 
the new warning label are not readily quantifiable, but it is expected 
to reduce the risk of the bassinet from tipping and thus, reduce 
potential injury to pediatric patients.
    The provision allowing for the medical cribs outside of traditional 
health care settings would benefit pediatric patients who require the 
specialized care provided by these devices outside of traditional 
health care settings. Due to the CPSC rule regarding cribs used for 
non-medical purposes, discussed previously, consumers and child care 
facilities are restricted from using cribs with a drop-side rail 
design. If this proposed rule is finalized, it will allow consumers and 
child care facilities to utilize the pediatric medical cribs if they 
are prescribed by a health care professional.
    The special controls regarding the mechanical structure of 
pediatric medical cribs are intended to minimize the risk of injury, 
including entrapment or strangulation of pediatric patients. The 
spacing specifications of the side rail components are designed to 
prevent head or neck entrapment and strangulation incidents in which 
infants may slip between the openings of the slats, and the performance 
testing requirements are designed to ensure the side rail latches of 
pediatric medical cribs will perform as intended and remain secure when 
the latches are engaged. The special control requiring specific height 
of the rails and end panels may prevent falls and/or escapes by the 
patient. Also, by having pediatric medical crib manufacturers use 
materials that are appropriate for the conditions of use and allow for 
proper sanitation, these special controls may help mitigate surface 
defects that can cause injury to the patient.
    Additionally, the mattress size standards for cribs and bassinets 
are intended to reduce the risk of significant gaps between the 
mattress and the device structure, which could potentially create an 
entrapment hazard. The flammability standard is intended to reduce 
deaths and injuries related to mattress fires, particularly those 
initially ignited by open flame sources such as lighters, candles, and 
matches. Although the practices proposed in these special controls are 
believed to be followed by almost all manufacturers of products 
currently on the market, the proposed special controls would reinforce 
safety standards for such manufacturers and ensure that other 
manufacturers and manufacturers of new products adhere to the same 
safety standards.

C. Costs

    The economic impact of the proposed regulation is determined 
primarily by whether manufacturers currently comply with the proposed 
special controls. As stated previously, the special controls that are 
not currently practiced by industry, of which FDA is aware, are the 
bassinet warning labeling and the performance testing requirements. FDA 
is also aware that many manufacturers of pediatric medical cribs and 
medical bassinets registered with the FDA currently conform to the risk 
mitigations and structural requirements that are being proposed as 
special controls, and thus conforming to these special controls, if 
finalized, would not result in an increase in cost to pediatric medical 
crib manufacturers and only cause a small increase in cost for medical 
bassinet manufactures. Additionally, the renaming of pediatric medical 
cribs and redesignation in the CFR for medical bassinets and the 
remaining devices under the pediatric hospital bed classification are 
administrative in nature, and are not expected to result in any cost 
burdens.
    The new warning labeling requirements for medical bassinets will 
apply to manufacturers of new bassinets only. FDA does not expect 
bassinets that are currently on the market to be relabeled. If 
manufacturers of new bassinets add labels to the devices at the

[[Page 60816]]

time of production, the cost burden to manufacturers would be 
minimized. Although we do not have direct estimates of labeling costs 
for these devices, the best estimate of these costs is derived from 
FDA's labeling cost model. Because FDA would require specific language 
and format of the labels, we consider this to be a minor labeling 
change that would not require label design, market tests, or analytical 
tests. Labeling costs would include labor and material, and are 
estimated to be, on average, approximately $140 per unit. Then we use 
the number of live births per year as reported by the Center for 
Disease Control and Prevention in order to determine the number of 
bassinets produced per year for medical use (Ref. 5). Using an estimate 
of 4 million births per year and 11,000 births per day, we estimate 
that each birth requires an average hospital stay of 3 days. This 
yields a total supply of approximately 33,000 medical bassinets in the 
United States. Given an average yearly replacement rate of 20 percent 
for all medical bassinets, we estimate that approximately 6,600 new 
bassinets will be produced annually. Applying the $140 per unit 
labeling cost yields a total yearly cost of $924,000 associated with 
the new bassinet warning label requirement.
    The special controls require performance testing for medical 
bassinets to reduce the risk of crazing of the plastic basket or bed 
component. We assume that the performance testing may be conducted as 
an extension to current product testing and may be performed at the 
same testing facilities currently utilized by bassinet manufacturers. 
FDA projects that a maximum of an additional week of testing would be 
required. The costs associated with the performance testing include the 
labor costs of mechanical engineers, who typically perform these tests. 
The mean 2012 hourly wage for mechanical engineers is $40.75, as 
reported by the Occupational Employment Statistics provided by the 
Bureau of Labor Statistics (Ref. 6). Applying a multiplier of 1.45 to 
adjust for benefits, hourly labor costs are estimated to be 
approximately $59. Assuming a 40-hour work week, the total maximum 
estimated cost for each manufacturer to perform these additional tests 
is approximately $2,360. It is uncertain the exact number of 
manufacturers that do not currently conduct performance testing and 
would therefore be required to extend current testing practices. 
However, given the relatively small number of medical bassinet 
manufacturers, FDA anticipates that even the upper-bound total cost 
would be modest.
    The prescription use of pediatric medical cribs outside of 
traditional health care settings may potentially increase Medicaid 
spending for eligible pediatric patients. According to our review of 
Healthcare Common Procedure Coding System billing codes for the 
Medicaid program, currently, States typically offer Medicaid coverage 
for prescribed rental or purchase of hospital beds and pediatric cribs 
(Ref. 7). We estimate the number of additional prescriptions for 
pediatric medical cribs to be filled annually as a result of this 
proposed rule would be less than 100. Medicaid expenditure on pediatric 
medical cribs is estimated to be on average $2,500 per device. This 
yields a maximum annual total cost of $250,000.
    Although it is unlikely that these devices would require physical 
modification to meet the standards proposed by the special controls in 
this proposed rule, there may be manufacturers on the market of which 
we are unaware that do not conform to the requirements proposed in the 
special controls. The proposed special controls could have a 
significant impact on firms that are not currently in compliance with 
the special controls, as their products may require modifications. The 
special control that may cause additional costs for manufacturers is 
the special control concerning the mechanical structure of pediatric 
medical cribs. We are not able to estimate the actual compliance costs 
for manufacturers of pediatric medical cribs because such costs may 
vary by firm size and the amount of modification required. 
Alternatively, we provide an estimate of the modification cost by using 
aggregate industry market price information and cost data. The costs 
associated with these modifications may include the costs associated 
with product design and testing, labor, material, and production. We 
use data from the Annual Survey of Manufacturers to calculate aggregate 
labor and materials costs as a percentage of total sales for 
manufacturers represented by North American Industry Classification 
System code 339113 (Ref. 8). The data indicate that labor and materials 
represent approximately 45 percent of total sales. Allowing market 
price to represent per unit revenue at the firm level, we estimate the 
cost of modification to be approximately 45 percent of the average 
price of a pediatric medical crib. After surveying market prices of 
pediatric medical cribs, we estimate an average per unit price of 
$2,500. This yields an average cost of approximately $1,125 to modify a 
pediatric medical crib to be in compliance with the proposed special 
controls.
    FDA invites comments on the compliance of manufacturers with the 
special controls, including the performance testing, mechanical 
structure, flammability requirements, and bassinet labeling 
requirements, as well as cost information if modifications are 
required.

X. Paperwork Reduction Act of 1995

    The proposed rule refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management Budget (OMB) and the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections 
of information, regarding premarket notification submissions (21 CFR 
part 807, subpart E), are approved under OMB control number 0910-0120. 
The collections of information, regarding labeling (21 CFR part 801), 
including prescription device labeling and adequate directions for use, 
are approved under OMB control number 0910-0485. The collections of 
information regarding current good manufacturing practice quality 
systems (21 CFR part 820), including design controls (as referenced in 
proposed Sec.  880.5140(b)(1) and proposed Sec.  880.5145(b)(1) and 
(b)(3) of this document), are approved under OMB control number 0910-
0073. The collections of information in 16 CFR 1632 and 1633, regarding 
mattress flammability, are approved under OMB control number 3041-0014.
    In addition, FDA concludes that the warning label for bassinets 
does not constitute a ``collection of information'' under the PRA. 
Rather, the labeling statement is ``public disclosure(s) of information 
originally supplied by the Federal government to the recipient for the 
purpose of disclosure to the public.'' (5 CFR 1320.3(c)(2)).

XI. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and are available electronically at http://www.regulations.gov. (FDA 
has verified the Web site addresses, but FDA is not responsible for any 
subsequent changes to the Web sites after this document publishes in 
the Federal Register.)

1. MedSun: Newsletter #66: ``Pediatric Hospital Cribs: MedSun Small 
Sample Survey Summary'' (November 2011),

[[Page 60817]]

available at http://www.fda.gov/downloads/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/Newsletters/UCM422131.pdf.
2. ASTM International (formerly the American Society for Testing and 
Materials), ``Standard Consumer Safety Specifications for Full-Size 
Baby Cribs,'' Designation: F1169-13, available at http://www.astm.org/Standards/F1169.htm, 2013.
3. ASTM International (formerly the American Society for Testing and 
Materials), ``Standard Consumer Safety Performance Specification for 
Commercial Cribs,'' Designation: F2710-13, available at http://www.astm.org/Standards/F2710.htm, 2013.
4. ASTM International, ``Standard Test Method for Measuring the 
Ignition Strength of Cigarettes,'' Designation: E2187-09 Standard, 
available at http://www.astm.org/Standards/E2187.htm.
5. Centers for Disease Control and Prevention (CDC), National Vital 
Statistics System, Birth Data, available at http://www.cdc.gov/nchs/births.htm.
6. Occupational Employment Statistics provided by the Bureau of 
Labor Statistics, May 2012 Occupational Employment Statistics, 
available at http://www.bls.gov/oes/2012/may/oes_stru.htm.
7. Centers for Medicare & Medicaid Services, HCPCS 2015 Code: E0300, 
available at http://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/index.html?redirect=/medhcpcsgeninfo/.
8. U.S. Census Bureau, 2013 Annual Survey of Manufacturers, 
available at http://www.census.gov/manufacturing/asm/index.html.

List of Subjects in 21 CFR Part 880

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act 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

0
1. The authority citation for 21 CFR part 880 continues to read as 
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Revise Sec.  880.5140 to read as follows:


Sec.  880.5140  Pediatric medical crib.

    (a) Identification. A pediatric medical crib is a prescription 
device intended for medical purposes for use with a pediatric patient 
that consists of an open crib, fixed-end rails, movable and latchable 
side rail components, and possibly an accompanying mattress. The 
contour of the crib surface may be adjustable.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec.  880.9. The special controls for 
this device are:
    (1) Crib design and performance testing shall demonstrate the 
mechanical and structural stability of the crib under expected 
conditions of use, including the security of latches and other locking 
mechanisms when engaged;
    (2) Materials used shall be appropriate for the conditions of use, 
allow for proper sanitation and free from surface defects that could 
result in injuries;
    (3) Rails and end panels shall be designed taking into account the 
crib's height at its lowest point to the top of the mattress to prevent 
patient falls and/or escape. Hardware and fasteners shall be designed 
and constructed to eliminate mechanical hazards to the patient;
    (4) The distance between components of the side rail (such as 
slats, spindles, and corner posts) shall not be greater than 2\3/8\ 
inches (6 centimeters (cm)) apart at any point. Side rails shall 
contain safety features for locking and adjust the lowest position of 
the crib to a height that shall be 20 inches (51 cm) above the top of 
the mattress;
    (5) The device shall not have a gap between the bottom of the rail 
and the top surface of the mattress and the mattress pad must fit 
tightly around all four sides of the crib;
    (6) The mattress for the crib shall meet the Consumer Product 
Safety Commission (CPSC) Standard for the Flammability of Mattresses 
and Mattress Pads and Standard for the Flammability (Open Flame) of 
Mattress Sets, 16 CFR parts 1632 and 1633, respectively;
    (7) The labeling must bear all information required pursuant to the 
CPSC Standard for the Flammability of Mattresses and Mattress Pads and 
Standard for the Flammability (Open Flame) of Mattress Sets, 16 CFR 
parts 1632 and 1633, respectively; and
    (8) Pediatric medical crib labeling must include adequate 
instructions for users to care for and maintain their crib.
0
3. Add Sec.  880.5145 to subpart F to read as follows:


Sec.  880.5145  Medical bassinet.

    (a) Identification. A medical bassinet is a prescription device 
that is a small bed intended for use with pediatric patients, generally 
from birth to approximately 5 months of age. It is intended for medical 
purposes for use in a nursery, labor and delivery unit, or patient 
room, but may also be used outside of traditional health care settings. 
A medical bassinet is a non-powered device that consists of two 
components: The plastic basket or bed component and a durable frame 
with wheels, which holds the basket or bed component. The basket or bed 
component is a box-like structure, generally made of a clear, high 
impact-resistant plastic material, with an open top and four stationary 
walls to hold the pediatric patient. The frame can include drawers, 
shelving or cabinetry that provides space to hold baby care items. The 
wheels or casters allow the bassinet to transport the baby throughout 
the care setting.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec.  880.9. The special controls for 
this device are:
    (1) The manufacturer must conduct performance testing to determine 
material compatibility with cleansing products labeled to clean the 
device. Testing must demonstrate that the cleaning instructions 
provided by the manufacturer do not cause crazing, cracking, or 
deterioration of the device;
    (2) The mattress for the device shall meet the Consumer Product 
Safety Commission Standard for the Flammability of Mattresses and 
Mattress Pads and Standard for the Flammability (Open Flame) of 
Mattress Sets, 16 CFR parts 1632 and 1633, respectively;
    (3) Manufacturers shall conduct performance testing to ensure the 
mechanical and structural stability of the bassinet under expected use 
conditions, including transport of patients in the bassinet. Testing 
must demonstrate that failures such as wheel or caster breakage do not 
occur, and that the device does not present a tipping hazard due to any 
mechanical failures, under expected use conditions;
    (4) Each device must have affixed a label on the front of the 
bassinet cabinet with the following language in text of at least 10 
millimeters in height:

    WARNING: To avoid tipping hazards of this device, make sure that 
the basket or bed component sits firmly in the base and that all 
doors, drawers, and casters are secure.

    (5) Labeling must include adequate instructions for users to care 
for and maintain their bassinet.

    Dated: October 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-25627 Filed 10-7-15; 8:45 a.m.]
 BILLING CODE 4164-01-P