39098 Federal Register / Vol. 63, No. 139 /Tuesday, July 21, 1998 / Notices

2. The date the application was

initially submitted with respect to the

human drug product under section 505

of the act: April 15, 1996. FDA has

verified the applicant’s claim that the

new drug application (NDA) for

FlowmaxTM (NDA 20–579) was initially

submitted on April 15, 1996.

3. The date the application was

approved: April 15, 1997. FDA has

verified the applicant’s claim that NDA

20–579 was approved on April 15, 1997.

This determination of the regulatory

review period establishes the maximum

potential length of a patent extension.

However, the U.S. Patent and

Trademark Office applies several

statutory limitations in its calculations

of the actual period for patent extension.

In its application for patent extension,

this applicant seeks 1,825 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before September 21, 1998, submit

to the Dockets Management Branch

(address above) written comments and

ask for a redetermination. Furthermore,

any interested person may petition FDA,

on or before January 19, 1998, for a

determination regarding whether the

applicant for extension acted with due

diligence during the regulatory review

period. To meet its burden, the petition

must contain sufficient facts to merit an

FDA investigation. (See H. Rept. 857,

part 1, 98th Cong., 2d sess., pp. 41–42,

1984.) Petitions should be in the format

specified in 21 CFR 10.30.

Comments and petitions should be

submitted to the Dockets Management

Branch (address above) in three copies

(except that individuals may submit

single copies) and identified with the

docket number found in brackets in the

heading of this document. Comments

and petitions may be seen in the

Dockets Management Branch between 9

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

Friday.

Dated: June 26, 1998.

Thomas J. McGinnis,

Deputy Associate Commissioner for Health

Affairs.

[FR Doc. 98–19379 Filed 7–20–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 98N–0473, 98P–0275, 98P–

0215, 98P–0216, and 98P–0338]

Medical Devices; Exemptions From

Premarket Notification; Class II

Devices

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is publishing a

list of petitions requesting exemption

from the premarket notification

requirements for certain class II devices.

FDA is publishing this notice in order

to obtain comments on these petitions

in accordance with procedures

established by the Food and Drug

Administration Modernization Act of

1997 (FDAMA).

DATES: Written comments by August 20,

1998.

ADDRESSES: Submit written comments

on this notice to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

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 Federal

Food, Drug, and Cosmetic Act (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 Medical

Device Amendments of 1976 (the 1976

amendments (Pub. L. 94–295)), as

amended by the Safe Medical Devices

Act of 1990 (the SMDA (Pub. L. 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

assure 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, 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.

On November 21, 1997, the President

signed into law FDAMA (Pub. L. 105–

115). Section 206 of FDAMA, in part,

added a new section 510(m) to the act.

Section 510(m)(1) of the act requires

FDA, within 60 days after enactment of

FDAMA, to publish in the Federal

Register a list of each type of class II

device that does not require a report

under section 510(k) of the act to

provide reasonable assurance of safety

and effectiveness. Section 510(m) of the

act further provides that a 510(k) will no

longer be required for these devices

upon the date of publication of the list

in the Federal Register. FDA published

that list in the Federal Register of

January 21, 1998 (63 FR 3142).

Section 510(m)(2) of the act provides

that, 1 day after date of publication of

the list under section 510(m)(1), FDA

may exempt a device 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. This section

requires FDA to publish in the Federal

Register a notice of intent to exempt a

device, or of the petition, and to provide

a 30-day comment period. Within 120

days of publication of this document,

FDA must publish in the Federal

Register its final determination
Federal Register / Vol. 63, No. 139 /Tuesday, July 21, 1998 / Notices 39099

regarding the exemption of the device

that was the subject of the notice. If FDA

fails to respond to a petition under this

section within 180 days of receiving it,

the petition shall be deemed granted.

II. Criteria for Exemption

There are a number of factors FDA

may consider to determine whether a

510(k) is necessary to provide

reasonable assurance of the safety and

effectiveness of a class II device. These

factors are discussed in the guidance the

agency issued on February 19, 1998,

entitled ‘‘Procedures for Class II Device

Exemptions from Premarket

Notification, Guidance for Industry and

CDRH Staff.’’ That guidance can be

obtained through the World Wide Web

on the CDRH Home Page at ‘‘http://

www.fda.gov/cdrh’’ or by facsimile

through CDRH Facts-on-Demand at 1–

800–899–0381 or 301–827–0111.

Specify ‘‘159’’ when prompted for the

document shelf number.

III. List of Petitions

FDA has received the following

petitions requesting an exemption from

premarket notification for class II

devices:

1. Sandhill Scientific Inc., 21 CFR

876.1725 Gastrointestinal motility

monitoring system.

2. Welch Allyn, Inc., 21 CFR 886.1570

Ophthalmoscope.

3. Computerized Medical Systems,

Inc., 21 CFR 892.5840 Radiation therapy

simulation system, exemption requested

only for Radiation Oncologist Data Entry

Workstation.

4. Chemicon International Inc., 21

CFR 866.3175 Cytomegalovirus

serological reagents, and 21 CFR

866.3900 Varicella-zoster virus

serological reagents.

IV. Comments

Interested persons may, on or before

August 20, 1998, submit to the Dockets

Management Branch (address above)

written comments regarding this notice.

Two copies of any comments are to be

submitted, except that individuals may

submit one copy. Comments are to be

identified with the docket number

found in brackets in the heading of this

document. The petitions and received

comments may be seen in the office

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

Monday through Friday.

Dated: July 10, 1998.

D.B. Burlington,

Director, Center for Devices and Radiological

Health.

[FR Doc. 98–19316 Filed 7–20–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0437]

New Model Medical Device

Development Process; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration FDA is announcing the

availability of a document entitled

‘‘New Model Medical Device

Development Process.’’ In this

document, FDA outlines a new model

for the investigational device exemption

(IDE) and premarket approval

application (PMA) development and

review process. FDA is issuing this

document as part of its commitment to

improve the IDE and PMA development

and review process.

DATES: Written comments concerning

this document must be received by

October 19, 1998.

ADDRESSES: See the SUPPLEMENTARY

INFORMATION section for information on

electronic access to the document.

Written comments concerning this

document must be submitted to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852. Comments should be

identified with the docket number

found in brackets in the heading of this

document. Submit written requests for

single copies on a 3.5’’ diskette of ‘‘New

Model Medical Device Development

Process’’ to the Division of Small

Manufacturers Assistance, Center for

Devices and Radiological Health (HFZ–

220), Food and Drug Administration,

1350 Piccard Dr., Rockville, MD 20850.

Send two self-addressed adhesive labels

to assist that office in processing your

request, or fax your request to 301–443–

8818.

FOR FURTHER INFORMATION CONTACT:

Robert R. Gatling, Center for Devices

and Radiological Health (HFZ–470),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1220.

SUPPLEMENTARY INFORMATION:

I. Background

Despite a marked improvement in

device approval times, FDA’s Center for

Devices and Radiological Health (CDRH)

is committed to substantial

improvement of the IDE application and

PMA development and review process.

Often FDA’s involvement with the

product has been greatest at the end of

the process—during review of the PMA.

The lack of early and effective FDA and

sponsor interaction too often results in

a PMA with significant flaws requiring

repair, including development of

additional data, and multiple cycles of

PMA review. These cycles can be costly

and time consuming both for the

medical device industry and FDA and

can delay marketing of new devices.

As part of its reengineering process,

CDRH is proposing a new model for the

development and review of such class

III medical devices that includes three

tracks: (1) ‘‘Expedited’’ review for

devices which offer significant

advantages over current therapy; (2)

‘‘standard’’ review for most devices; and

(3) ‘‘streamlined’’ review for devices

which are very well understood by both

the sponsor and FDA.

The new model also encourages

interaction between the agency and the

applicant, including early agreement on

the overall development plan, and offers

modular submission and review

building the application and

administrative file over time.

The guidance document outlines why

FDA believes that the model will lead

to ‘‘fast, fair, and smart’’ decisions that

bring safe and effective devices to

market as early as possible.

This guidance document represents

the agency’s current thinking on

expediting the IDE/PMA process. It does

not create or confer any rights for or on

any person and does not operate to bind

FDA or the public. An alternative

approach may be used if such approach

satisfies the applicable statute,

regulations or both. FDA is issuing this

as a Level 1 guidance document. Public

comment prior to implementation is not

required because the guidance is

presenting a less burdensome policy

that is consistent with the public health.

II. Electronic Access

In order to receive ‘‘New Model

Medical Device Development Process’’

via your fax machine, call the CDRH

Facts-On-Demand (FOD) system at 1–

800–899–0381 or 301–827–0111 from a

touch-tone telephone. At the first voice

prompt press 1 to access DSMA Facts,

at second voice prompt press 2, and

then enter the document number (1101)

followed by the pound sign (#). Then

follow the remaining voice prompts to

complete your request.

Persons interested in obtaining a copy

of the guidance may also do so using the

World Wide Web (WWW). CDRH

maintains an entry on the WWW for

easy access to information including

text, graphics, and files that may be

downloaded to a personal computer