Federal Register / Vol. 65, No. 10 / Friday, January 14, 2000 / Rules and Regulations 2295

From To MEA MAA

§ 95.7001 Jet Routes

§ 95.7189 Jet Route No. 189 is Amended to Read in Part

Klamath Falls, OR VORTAC ............................................ Battle Ground, WA VORTAC ........................................... #19000 45000

#MEA is established with a gap in navigation signal coverage

§ 95.8003 VOR Federal Airway Changeover Points Airway Segment V–16 is Amended to Add Changeover Point

From To

Changeover points

Distance From

Pulaski, VA VORTAC ........................................................ Roanoke, VA VORTAC .................................................... 10 Pulaski

V–603 is Amended to Add Changeover Point

Elfee, AK NDB .................................................................. Dillingham, AK VOR/DME ................................................ 207 Elfee

V–617 is Amended to Add Changeover Point

Homer, AK VORTAC ........................................................ Johnstone Point, AK VORTAC ........................................ 63 Homer

§ 95.8005 Jet Routes Changeover Points Airway Segment J–189 is Amended to Modify Changeover Point

Klamath Falls, OR VORTAC ............................................. Battle Ground, WA VORTAC ........................................... 78 Klamath

Falls

#MEA is established with a gap in navigation signal covera

[FR Doc. 00–933 Filed 1–13–00; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Parts 121, 125

[Docket No. FAA–1999–6140; Amendment

Nos. 121–271 and 125–32]

RIN 2120–AG88

Revisions to Digital Flight Data

Recorder Requirements for Airbus

Airplanes; Correction

AGENCY: Federal Aviation

Administration (FAA), DOT.

ACTION: Final Rule; correction.

SUMMARY: The FAA published a final

rule in the Federal Register on August

24, 1999, (64 FR 46117). The rule

amended the flight data recorder

regulations by adding language to allow

certain Airbus airplanes to record

certain data parameters using resolution

and sampling requirements that differed

slightly from the regulation. This

document makes certain corrections to

Appendix E to Part 125, Airplane Flight

Recorder Specifications.

EFFECTIVE DATE: August 17, 1999.

FOR FURTHER INFORMATION CONTACT: Gary

E. Davis, Air Carrier Operations Branch

(AFS–201), Flight Standards Service,

Federal Aviation Administration, 800

Independence Avenue, SW.,

Washington, DC 20591, telephone (202)

267–8166.

SUPPLEMENTARY INFORMATION: On August

24, 1999, the FAA published an

amendment to the flight data recorder

requirements of 14 CFR Parts 121 and

125 (64 FR 46117). In the amendment to

Appendix E to Part 125, Airplane Flight

Recorder Specifications, one parameter

listing was inadvertently omitted. This

action corrects that omission.

Correction

In FR Doc. 99–21783, published on

August 24, 1999 (64 FR 46117), make

the following correction:

On page 46122, third column, in

Appendix E to Part 125, Airplane Flight

Recorder Specifications, insert

parameter 21, in numerical order, to

read as follows:

* * * * *

Appendix E to Part 125—Airplane

Flight Recorder Specifications

The recorded values must meet the

designated range, resolution, and

accuracy requirements during dynamic

and static conditions. All data recorded

must be correlated in time to within one

second.

Parameters Range

Accuracy

(sensor

input)

Seconds

per sampling

interval

Resolution Remarks

*******

21. Leading Edge Flap or Cockpit Control Selection 11.

*******

2296 Federal Register / Vol. 65, No. 10 / Friday, January 14, 2000 / Rules and Regulations

* * * * *

Issued in Washington, DC on January 12,

2000.

Donald P. Byrne,

Assistant Chief Counsel, Regulations

Division.

[FR Doc. 00–1056 Filed 1–13–00; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 862, 864, 866, 868, 870,

872, 874, 876, 878, 880, 882, 884, 886,

888, 890, and 892

[Docket No. 98N–0009]

Medical Devices; Exemption From

Premarket Notification and Reserved

Devices; Class I

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending its

classification regulations to designate

class I devices that are exempt from the

premarket notification requirements,

subject to certain limitations, and to

designate those class I devices that

remain subject to premarket notification

requirements under the new statutory

criteria for premarket notification

requirements. The devices FDA is

designating as exempt do not include

class I devices that have been previously

exempted by regulation from the

premarket notification requirements.

This action is being taken under the

Federal Food, Drug, and Cosmetic Act

(the act), as amended by the Medical

Device Amendments of 1976 (the 1976

amendments), the Safe Medical Devices

Act of 1990 (SMDA), and the FDA

Modernization Act of 1997 (FDAMA).

FDA is taking this action in order to

implement a requirement of FDAMA.

Elsewhere in this issue of the Federal

Register, FDA is announcing that it is

withdrawing proposed rules to revoke

existing exemptions from premarket

notification for two devices.

DATES: This regulation is effective

February 14, 2000.

FOR FURTHER INFORMATION CONTACT:

Heather S. Rosecrans, Center for Devices

and Radiological Health (HFZ–404),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1190.

SUPPLEMENTARY INFORMATION:

I. Statutory Background

Under section 513 of the act (21

U.S.C. 360c), FDA must classify devices

into one of three regulatory classes:

Class I, class II, or class III. FDA

classification of a device is determined

by the amount of regulation necessary to

provide a reasonable assurance of safety

and effectiveness. Under the 1976

amendments (Public Law 94–295), as

amended by the SMDA (Public Law

101–629), devices are to be classified

into class I (general controls) if there is

information showing that the general

controls of the act are sufficient to

ensure safety and effectiveness; into

class II (special controls), if general

controls, by themselves, are insufficient

to provide reasonable assurance of

safety and effectiveness, but there is

sufficient information to establish

special controls to provide such

assurance; and into class III (premarket

approval), if there is insufficient

information to support classifying a

device into class I or class II and the

device is a life-sustaining or lifesupporting device, or is for a use which

is of substantial importance in

preventing impairment of human

health, or presents a potential

unreasonable risk of illness or injury.

Most generic types of devices that

were on the market before the date of

the 1976 amendments (May 28, 1976)

(generally referred to as preamendments

devices) have been classified by FDA

under the procedures set forth in section

513(c) and (d) of the act through the

issuance of classification regulations

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 postamendments devices) are

classified through the premarket

notification process under section

510(k) of the act (21 U.S.C. 360(k)).

Section 510(k) of the act and the

implementing regulations, part 807 (21

CFR part 807), require persons who

intend to market a new device 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 act to

a legally marketed device that does not

require premarket approval. Unless

exempted from premarket notification

requirements, persons may not market a

new device under section 510(k) of the

act, unless they receive a substantial

equivalence order from FDA or an order

reclassifying the device into class I or

class II, under section 513(f) of the act.

On November 21, 1997, the President

signed FDAMA into law (Public Law

105–115). Section 206 of FDAMA, in

part, added a new section 510(l) to the

act. Under section 206 of FDAMA, new

section 510(l) of the act became effective

on February 19, 1998. New section

510(l) of the act provides that a class I

device is exempt from the premarket

notification requirements under section

510(k) of the act, unless the device is

intended for a use which is of

substantial importance in preventing

impairment of human health or it

presents a potential unreasonable risk of

illness or injury. This document refers

to devices that FDA believes meet these

criteria as ‘‘reserved.’’ FDA has

evaluated all class I devices to

determine which device types should be

subject to premarket notification

requirements.

In developing the list of reserved

devices, the agency considered its

experience in reviewing premarket

notifications for these device types,

focusing on the risk inherent with the

device and/or the disease being treated

or diagnosed. FDA believes that the

devices listed as reserved are intended

for a use that is of substantial

importance in preventing impairment of

human health or present a potential

unreasonable risk of illness or injury.

II. Limitations on Exemptions

FDA believes that the generic types of

class I devices listed herein, in addition

to a vast majority of class I devices

previously exempted, should be exempt

from the premarket notification

requirements under section 510(l) of the

act. FDA further believes, however, that

these generic device categories should

be exempt only to the extent that they

have existing or reasonably foreseeable

characteristics of commercially

distributed devices within that generic

type or, in the case of in vitro diagnostic

devices (IVD’s), only to the extent that

misdiagnosis as a result of using the

device would not be associated with

high morbidity or mortality. FDA

believes that certain changes to devices

within a generic device type that is

generally exempt may make the device

intended for a use that is of substantial

importance in preventing impairment of

human health or may make the device

present a potential unreasonable risk of

illness or injury. Accordingly, devices

changed in this manner would fall

within the reserved criteria under

section 510(l) of the act and would

require premarket notification.

FDA believes that devices that have

different intended uses than legally

marketed devices in that generic device

type present a potential unreasonable

risk of illness or injury because their

safety and effectiveness characteristics