23382 Federal Register / Vol. 63, No. 82 /Wednesday, April 29, 1998 /Rules and Regulations

Aerospatiale Modification 01392 has not

been installed, certificated in any category.

Note 1: This AD applies to each airplane

identified in the preceding applicability

provision, regardless of whether it has been

otherwise modified, altered, or repaired in

the area subject to the requirements of this

AD. For airplanes that have been modified,

altered, or repaired so that the performance

of the requirements of this AD is affected, the

owner/operator must request approval for an

alternative method of compliance in

accordance with paragraph (b) of this AD.

The request should include an assessment of

the effect of the modification, alteration, or

repair on the unsafe condition addressed by

this AD; and, if the unsafe condition has not

been eliminated, the request should include

specific proposed actions to address it.

Compliance: Required as indicated, unless

accomplished previously.

To prevent reduced structural integrity of

the airplane resulting from fatigue cracking of

the windshield frame structure, accomplish

the following:

(a) Prior to the accumulation of 24,000 total

flight cycles, or within 60 days after the

effective date of this AD, whichever occurs

later: Inspect to detect cracking of the

windshield frame structure in accordance

with Operation Description (B—Inspection)

of the Accomplishment Instructions of

Aerospatiale Service Bulletin ATR42–53–

0093, Revision 1, or ATR42–53–0094,

Revision 2, both dated February 19, 1996.

(1) If the inspection reveals no crack, or

reveals cracking that does not exceed the

specifications listed in Figure 6, Sheet 1, of

Service Bulletin ATR42–53–0093, Revision 1,

dated February 19, 1996: Prior to further

flight, modify the windshield frame structure

in accordance with either service bulletin.

(2) If the inspection reveals any crack that

exceeds the specifications in Figure 6, Sheet

1, of Service Bulletin ATR42–53–0093,

Revision 1, dated February 19, 1996, but does

not exceed the cut-out areas specified in

Figure 7, Sheet 1, of Service Bulletin ATR42–

53–0094, Revision 2, dated February 19,

1996: Prior to further flight, modify the

windshield frame structure in accordance

with Service Bulletin 42–53–0094, Revision

2, dated February 19, 1996.

(3) If the inspection reveals any crack that

exceeds the cut-out areas specified in Figure

7, Sheet 1, of Service Bulletin ATR42–53–

0094, Revision 2, dated February 19, 1996:

Prior to further flight, modify the windshield

frame structure in accordance with a method

approved by the Manager, International

Branch, ANM–116, FAA, Transport Airplane

Directorate.

Note 2: Accomplishment of the

modifications specified in ATR Service

Bulletin ATR42–53–0093, Revision 1, or

ATR42–53–0094, Revision 2, both dated

February 19, 1996, is not equivalent to

accomplishment of Aerospatiale

Modification 01392. Therefore the ATR42

Time Limits Document inspection items with

‘‘PRE MOD 1392’’ effectivity are still

applicable for airplanes modified by either of

the previously described service bulletins.

(b) An alternative method of compliance or

adjustment of the compliance time that

provides an acceptable level of safety may be

used if approved by the Manager,

International Branch, ANM–116. Operators

shall submit their requests through an

appropriate FAA Principal Maintenance

Inspector, who may add comments and then

send it to the Manager, International Branch,

ANM–116.

Note 3: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the International Branch,

ANM–116.

(c) Special flight permits may be issued in

accordance with sections 21.197 and 21.199

of the Federal Aviation Regulations (14 CFR

21.197 and 21.199) to operate the airplane to

a location where the requirements of this AD

can be accomplished.

(d) The actions shall be done in accordance

with the following Aerospatiale Service

Bulletins, which contain the specified

effective pages:

Service bulletin referenced and date Page number shown on page

Revision

level

shown on

page

Date shown on page

ATR42–53–0093, Revision 1, February 19, 1996 ..... 1–4, 13 ....................................................................... 1 .............. February 19, 1996.

5–12, 14–41 ............................................................... Original .... April 26, 1995.

ATR42–53–0094, Revision 2, February 19, 1996 ..... 1, 2, 8, 9, 16, 18, 39, 40, 48, 53, 54 ......................... 2 .............. February 19, 1996.

3, 4, 7, 10–15, 17, 19–24, 26, 27, 29–32, 34–38,

47, 55, 56.

1 .............. May 29, 1995.

5, 6, 25, 28, 33, 41–46, 49–52 .................................. Original .... April 24, 1995

This incorporation by reference was

approved by the Director of the Federal

Register in accordance with 5 U.S.C. 552(a)

and 1 CFR part 51. Copies may be obtained

from Aerospatiale, 316 Route de Bayonne,

31060 Toulouse, Cedex 03, France. Copies

may be inspected at the FAA, Transport

Airplane Directorate, 1601 Lind Avenue,

SW., Renton, Washington; or at the Office of

the Federal Register, 800 North Capitol

Street, NW., suite 700, Washington, DC.

Note 4: The subject of this AD is addressed

in French airworthiness directive 95–126–

061(B), dated June 21, 1995.

(e) This amendment becomes effective on

June 3, 1998.

Issued in Renton, Washington, on April 21,

1998.

Darrell M. Pederson,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 98–11068 Filed 4–28–98; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. 96–NM–59–AD; Amendment

39–10504; AD 98–09–23]

RIN 2120–AA64

Airworthiness Directives; Lockheed

Model L–1011 Series Airplanes

Equipped With Rolls Royce Model

RB211–22B Engines

AGENCY: Federal Aviation

Administration, DOT.

ACTION: Final rule.

SUMMARY: This amendment supersedes

an existing airworthiness directive (AD),

applicable to certain Lockheed Model

L–1011 series airplanes, that currently

requires various modifications and

corrective actions to prevent a potential

fire hazard caused by heat damage to the

flex fuel feed line from an undetected

gearbox fire. In lieu of the various

modifications and corrective actions,

that AD also provides for an optional

terminating action (i.e., installation of a

vent air tube in the gear compartment

and thickened gearbox housings) for

another existing AD. For airplanes on

which that optional terminating action

has been accomplished, this amendment

requires accomplishment of the various

modifications and corrective actions.

This amendment is prompted by a

report indicating that, due to bearing

failure, an in-flight fire occurred on an

airplane on which a thickened gearbox

housing was installed. The actions

specified by this AD are intended to

detect and correct bearing failure, which

could lead to a fire in the gearbox.

DATES: Effective June 3, 1998.

The incorporation by reference of

certain publications listed in the

regulations is approved by the Director

of the Federal Register as of June 3,

1998.
Federal Register / Vol. 63, No. 82 /Wednesday, April 29, 1998 /Rules and Regulations 23383

ADDRESSES: The service information

referenced in this AD may be obtained

from Lockheed Aeronautical Systems

Support Company (LASSC), Field

Support Department, Dept. 693, Zone

0755, 2251 Lake Park Drive, Smyrna,

Georgia 30080. This information may be

examined at the Federal Aviation

Administration (FAA), Transport

Airplane Directorate, Rules Docket,

1601 Lind Avenue, SW., Renton,

Washington; or at the FAA, Small

Airplane Directorate, Atlanta Aircraft

Certification Office, One Crown Center,

1895 Phoenix Boulevard, suite 450,

Atlanta, Georgia 30349; or at the Office

of the Federal Register, 800 North

Capitol Street, NW., suite 700,

Washington, DC.

FOR FURTHER INFORMATION CONTACT:

Thomas B. Peters, Aerospace Engineer,

Systems and Flight Test Branch, ACE–

116A, FAA, Small Airplane Directorate,

Atlanta Aircraft Certification Office,

One Crown Center, 1895 Phoenix

Boulevard, suite 450, Atlanta, Georgia

30349; telephone (770) 703–6063; fax

(770) 703–6097.

SUPPLEMENTARY INFORMATION: A

proposal to amend part 39 of the Federal

Aviation Regulations (14 CFR part 39)

by superseding AD 87–07–10,

amendment 39–5597 (52 FR 10736,

April 3, 1987), which is applicable to

certain Lockheed Model L–1011 series

airplanes, equipped with Rolls Royce

Model RB211–22B engines, was

published in the Federal Register on

July 18, 1997 (62 FR 38491). That action

proposed to continue to require various

modifications and corrective actions to

prevent a potential fire hazard caused

by heat damage to the flex fuel feed line

from an undetected gearbox fire. In lieu

of the various modifications and

corrective actions, that action also

provided for an optional terminating

action (i.e., installation of a vent air tube

in the gear compartment and thickened

gearbox housings) for another existing

AD. For airplanes on which the optional

terminating action has been

accomplished, that action proposed to

require accomplishment of the various

modifications and corrective actions.

Comments

Interested persons have been afforded

an opportunity to participate in the

making of this amendment. Due

consideration has been given to the

comments received.

One commenter supports the

proposed rule.

The Air Transport Association (ATA)

of America, on behalf of one of its

members, requests that any alternative

method of compliance approved

previously for compliance with

paragraphs (a) and (b) of AD 87–07–10

be approved as an alternative method of

compliance for this proposed AD. The

FAA concurs with the commenter’s

request. Paragraph (e) of this final rule

has been revised to indicate that any

approval of an alternative method of

compliance that was granted previously

for AD 87–07–10 is approved as an

alternative method of compliance with

the requirements of paragraphs (a) and

(b) of this AD.

The ATA, on behalf of another

commenter, states that the proposed AD

is unnecessary. The commenter notes

that the proposal is somewhat

redundant in that it only eliminates an

alternative method of compliance with

AD 87–07–10. The commenter further

states that neither AD 87–07–10 nor the

proposed AD does anything to address

the basic problem, which is failure of

accessory gearbox bearings. According

to the commenter, several

enhancements have been made over the

years to prevent bearing failures, which,

if unnoticed by available monitoring

methods (chip detectors), could result in

fires. The commenter believes that

proper management of the chip detector

monitoring and improvements available

to upgrade the accessory gearbox

bearings make the proposed AD and

contemplated breather temperature

sensors unnecessary. Last, the

commenter notes that the latest gearbox

fires did not occur in an RB211–22Bstyle gearbox.

The FAA does not concur that

issuance of this AD is unnecessary. The

commenter is correct in noting that the

latest gearbox fires did not occur in an

RB211–22B-style gearbox. Rather, fires

have occurred in engines with the

thicker, RB211–524-style gearbox

housings. In light of this more recent

service experience, it is evident that the

installation of the thicker gearbox

housings is not, in itself, sufficient to

eliminate the unsafe condition

addressed in AD 87–07–10. Therefore,

AD 87–07–10 is being superseded to

eliminate the installation of those

gearbox housings, without further

action, as an approved method of

compliance.

The commenter is also correct in

noting that the basic problem is failure

of accessory gearbox bearings. There are,

however, no known means to

completely eliminate the possibility that

such bearings could fail and precipitate

fires. It is, therefore, necessary to ensure

that any fire that does occur in the

gearbox housing can be detected in a

timely manner. Compliance with the

requirements of this AD will ensure

that, in the event such a fire does occur,

the flight crew can take corrective

action, i.e., engine shutdown and

discharge of the fire suppression system,

on a timely basis.

Conclusion

After careful review of the available

data, including the comments noted

above, the FAA has determined that air

safety and the public interest require the

adoption of the rule with the change

previously described. The FAA has

determined that this change will neither

increase the economic burden on any

operator nor increase the scope of the

AD.

Cost Impact

There are approximately 130

Lockheed Model L–1011 series

airplanes equipped with Rolls Royce

Model RB211–22B engines of the

affected design in the worldwide fleet.

The FAA estimates that 76 airplanes of

U.S. registry will be affected by this AD.

The actions that are currently

required by AD 87–07–10 take

approximately 3 work hours per engine

(3 engines per airplane) to accomplish,

at an average labor rate of $60 per work

hour. Required parts for Walter Kidde

systems will cost approximately $2,100

per engine. Required parts for Graviner

systems will cost approximately $8,100

per engine. Based on these figures, the

cost impact of the installation currently

required by AD 87–07–10 on U.S.

operators is estimated to be $6,840 per

airplane (for Walter Kidde systems) or

$24,840 per airplane (for Graviner

systems).

The required modification will take

approximately 6 work hours per

airplane to accomplish, at an average

labor rate of $60 per work hour.

Required parts will cost approximately

$10,000 per airplane. Based on these

figures, the cost impact on U.S.

operators of the modification required

by this AD is estimated to be $787,360,

or $10,360 per airplane.

The introduction of a vent air tube

will take approximately 3 work hours

per engine (3 engines per airplane) to

accomplish, at an average labor rate of

$60 per work hour. Required parts will

cost approximately $500 per engine.

Based on these figures, the cost impact

on U.S. operators of the introduction of

a vent air tube required by this AD is

estimated to be $155,040, or $2,040 per

airplane.

The cost impact figures discussed

above are based on assumptions that no

operator has yet accomplished any of

the current or proposed requirements of

this AD action, and that no operator

would accomplish those actions in the

future if this AD were not adopted.
23384 Federal Register / Vol. 63, No. 82 /Wednesday, April 29, 1998 /Rules and Regulations

Regulatory Impact

The regulations adopted herein will

not have substantial direct effects on the

States, on the relationship between the

national government and the States, or

on the distribution of power and

responsibilities among the various

levels of government. Therefore, in

accordance with Executive Order 12612,

it is determined that this final rule does

not have sufficient federalism

implications to warrant the preparation

of a Federalism Assessment.

For the reasons discussed above, I

certify that this action (1) is not a

‘‘significant regulatory action’’ under

Executive Order 12866; (2) is not a

‘‘significant rule’’ under DOT

Regulatory Policies and Procedures (44

FR 11034, February 26, 1979); and (3)

will not have a significant economic

impact, positive or negative, on a

substantial number of small entities

under the criteria of the Regulatory

Flexibility Act. A final evaluation has

been prepared for this action and it is

contained in the Rules Docket. A copy

of it may be obtained from the Rules

Docket at the location provided under

the caption ADDRESSES.

List of Subjects in 14 CFR Part 39

Air transportation, Aircraft, Aviation

safety, Incorporation by reference,

Safety.

Adoption of the Amendment

Accordingly, pursuant to the

authority delegated to me by the

Administrator, the Federal Aviation

Administration amends part 39 of the

Federal Aviation Regulations (14 CFR

part 39) as follows:

PART 39—AIRWORTHINESS

DIRECTIVES

1. The authority citation for part 39

continues to read as follows:

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

§ 39.13 [Amended]

2. Section 39.13 is amended by

removing amendment 39–5597 (52 FR

10736, April 3, 1987), and by adding a

new airworthiness directive (AD),

amendment 39–10504, to read as

follows:

98–09–23 Lockheed: Amendment 39–

10504. Docket 96–NM–59–AD.

Supersedes AD 87–07–10, Amendment

39–5597.

Applicability: Model L–1011 series

airplanes equipped with Rolls Royce RB211–

22B engines, certificated in any category.

Note 1: If an operator has accomplished the

requirements of paragraphs (a) and (b) of this

AD on any affected airplane and,

subsequently, installs a different Model

RB211–22B engine on that airplane, the

airplane and all installed engines are still

subject to the requirements of this AD.

Note 2: This AD applies to each airplane

identified in the preceding applicability

provision, regardless of whether it has been

modified, altered, or repaired in the area

subject to the requirements of this AD. For

airplanes that have been modified, altered, or

repaired so that the performance of the

requirements of this AD is affected, the

owner/operator must request approval for an

alternative method of compliance in

accordance with paragraph (e) of this AD.

The request should include an assessment of

the effect of the modification, alteration, or

repair on the unsafe condition addressed by

this AD; and, if the unsafe condition has not

been eliminated, the request should include

specific proposed actions to address it.

Compliance: Required as indicated, unless

accomplished previously.

To detect and correct bearing failure,

which could lead to a fire in the gearbox,

accomplish the following:

(a) Within 8,000 flight hours or 30 months

after May 8, 1987 (the effective date of AD

87–07–10, amendment 39–5597), whichever

occurs first, accomplish the procedures

specified in the Accomplishment

Instructions of the service bulletins listed in

paragraphs (a)(1) and (a)(2) of this AD.

(1) Lockheed Service Bulletin 093–26–036,

dated April 1, 1986, Installation of Fire

Detector Segment; and

(2) Lockheed Service Bulletin 093–71–067,

Revision 1, dated April 1, 1986, Gearbox

Breather Duct Modification.

(b) Within 8,000 flight hours or 30 months

after May 8, 1987, whichever occurs first,

accomplish the procedures specified in the

Accomplishment Instructions of the service

bulletins listed in paragraphs (b)(1) and (b)(2)

of this AD.

(1) Rolls Royce Service Bulletin RB.211–

72–4666, Revision 3, dated October 14, 1977,

Introduction of Vent Air Tube in Gear

Compartment; and

(2) Rolls Royce Service Bulletin RB.211–

72–8138, dated March 21, 1986, Installation

of Additional No. 7 Fire Sensor.

(c) For airplanes on which Rolls Royce

Service Bulletin RB.211–72–4666, Revision

3, dated October 14, 1977, and Rolls Royce

Service Bulletin RB.211–72–3878, Revision

3, dated June 25, 1976, have been

accomplished in accordance with paragraph

C. of AD 87–07–10: Within 48 months or

16,000 flight hours after the effective date of

this AD, whichever occurs first, accomplish

the actions specified in paragraphs (a) and (b)

of this AD.

(d) Accomplishment of the requirements of

paragraphs (a) and (b) of this AD; or

accomplishment of the requirements of

paragraph (c) of this AD; constitutes

terminating action for the requirements of AD

85–09–03, amendment 39–5056. The AFM

limitations required by AD 85–09–03 may be

removed following accomplishment of the

terminating action.

(e)(1) An alternative method of compliance

or adjustment of the compliance time that

provides an acceptable level of safety may be

used if approved by the Manager, Atlanta

Aircraft Certification Office (ACO), FAA,

Small Airplane Directorate. Operators shall

submit their requests through an appropriate

FAA Principal Maintenance Inspector, who

may add comments and then send it to the

Manager, Atlanta ACO.

(2) Alternative methods of compliance,

approved previously in accordance with AD

87–07–10, amendment 39–5597, are

approved as alternative methods of

compliance with paragraphs (a) and (b) of

this AD.

Note 3: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Atlanta ACO.

(f) Special flight permits may be issued in

accordance with §§ 21.197 and 21.199 of the

Federal Aviation Regulations (14 CFR 21.197

and 21.199) to operate the airplane to a

location where the requirements of this AD

can be accomplished.

(g) The actions shall be done in accordance

with the following service bulletins, which

contain the specified effective pages:

Service bulletin referenced and date Page No.

Revision

level

shown on

page

Date shown on page

Lockheed Service Bulletin 093–26–036, April

1, 1986.

1–7 ................................................................. Original .... April 1, 1986.

Lockheed Service Bulletin 093–71–067, Revision 1, April 1, 1986.1–7, 9–11 ....................................................... 1 .............. April 1, 1986.

8 ..................................................................... Original .... February 5, 1986.

Rolls Royce Service Bulletin RB.211–72–

8138, March 21, 1986.

1–34 ............................................................... Original .... March 21, 1986.
Federal Register / Vol. 63, No. 82 /Wednesday, April 29, 1998 /Rules and Regulations 23385

Service bulletin referenced and date Page No.

Revision

level

shown on

page

Date shown on page

Rolls Royce Service Bulletin RB.211–72–

4666, Revision 3, October 14, 1977.

1 ..................................................................... 3 .............. October 14, 1977.

2–6, 6A, 7–10 ................................................ 2 .............. August 26, 1977.

This incorporation by reference was

approved by the Director of the Federal

Register in accordance with 5 U.S.C. 552(a)

and 1 CFR part 51. Copies may be obtained

from Lockheed Aeronautical Systems

Support Company (LASSC), Field Support

Department, Dept. 693, Zone 0755, 2251 Lake

Park Drive, Smyrna, Georgia 30080. Copies

may be inspected at the FAA, Transport

Airplane Directorate, 1601 Lind Avenue,

SW., Renton, Washington; or at the FAA,

Small Airplane Directorate, Atlanta Aircraft

Certification Office, One Crown Center, 1895

Phoenix Boulevard, Suite 450, Atlanta,

Georgia 30349; or at the Office of the Federal

Register, 800 North Capitol Street, NW., suite

700, Washington, DC.

(h) This amendment becomes effective on

June 3, 1998.

Issued in Renton, Washington, on April 21,

1998.

Gary L. Killion,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 98–11088 Filed 4–28–98; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 892

[Docket No. 96N–0320]

Radiology Devices; Classifications for

Five Medical Image Management

Devices

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is classifying five

radiology devices that provide functions

related to medical image

communication, storage, processing,

and display into class I (general

controls) or class II (special controls).

The medical image storage device and

medical image communications device

are classified into class I, and they are

exempted from the requirement of

premarket notification when they do not

use irreversible compression. The

medical image digitizer, the medical

image hardcopy device, and the picture

archiving and communications system

are classified into class II. These actions

are being taken under the Federal Food,

Drug, and Cosmetic Act (the act), as

amended by the Medical Device

Amendments of 1976 and the Safe

Medical Devices Act of 1990.

EFFECTIVE DATE: May 29, 1998.

FOR FURTHER INFORMATION CONTACT:

Loren A. Zaremba, Center for Devices

and Radiological Health (HFZ–470),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1212.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of December 2,

1996 (61 FR 63769), FDA issued a

proposed rule to classify five medical

image management devices into class I

or class II. The medical image storage

device and medical image

communications device were proposed

to be classified into class I, and

exempted from the requirement of

premarket notification when they do not

use irreversible compression. The

medical image digitizer, medical image

hardcopy device, and picture archiving

and communications system were

proposed to be classified into class II.

FDA provided for interested persons to

submit written comments on the

proposal by March 3, 1997.

II. Response to Comments

The agency received six comments

responding to the proposed rule. These

comments were submitted by a law

firm, two manufacturers of medical

image management devices, two

medical professional organizations, and

a medical device manufacturers’

association.

1. One comment expressed concern

that exempting medical image storage

devices from the requirement of

premarket notification would encourage

less experienced manufacturers to use

the marketplace as a testing ground for

their new products. This comment

stated that the medical image

management industry needs guidance

from FDA on material choices, labeling,

and quality assurance issues. The

comment also suggested that FDA

consider adopting minimum standards

relating to specifications, device

compatibility, lifetime, and labeling.

FDA agrees that the integrity of

medical image storage devices is

important in health care. The agency

does not believe, however, that

premarket notification is necessary to

ensure the safety and effectiveness of

these products. The agency believes that

other general controls, particularly the

good manufacturing practices

requirements (part 820) (21 CFR part

820)), which include controls on

production, packaging, labeling, and

recordkeeping, are sufficient to provide

reasonable assurance of their safety and

effectiveness. On November 21, 1997,

the President signed into law the Food

and Drug Administration Modernization

Act of 1997 (FDAMA) (Pub. L. 105–115).

Section 206(a)(2) of FDAMA added

sections 510(l) and 510(m) to the act (21

U.S.C. 360(l) and (m)). Section 510(l) of

the act provides that a premarket

notification is not required for a class I

device, unless the device is intended for

a use that is of substantial importance

in preventing impairment of human

health or the device presents a potential

unreasonable risk of illness or injury.

Section 510(m) of the act provides that

FDA may exempt a class II device from

the premarket notification requirements

if FDA determines that a premarket

notification is not necessary to provide

reasonable assurance of the safety and

effectiveness of the device. FDA has

determined that the medical image

storage device and the medical image

communications device do not require

premarket notifications in accordance

with the criteria in section 510(l) of the

act. Also, FDA has determined that the

medical image digitizer, the medical

image hardcopy device, and the picture

archiving and communication system

require premarket notification in order

to provide reasonable assurance of their

safety and effectiveness. The class II

devices in this rule will be subject to the

design control requirements in part 820,

while the class I devices will be exempt

from the design control requirements in

accordance with § 820.30. FDA believes

that design controls are not necessary

for class I devices in this rule. To

provide guidance to the industry, FDA

will continue to participate in the

activities of voluntary standards

organizations in the development of

recommendations relating to materials