29384 Federal Register / Vol. 79, No. 99 / Thursday, May 22, 2014 / Proposed Rules 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2014–0326; Directorate 

Identifier 2013–CE–051–AD] 

RIN 2120–AA64 

Airworthiness Directives; Rockwell 

Collins, Inc. Transponders 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: We propose to adopt a new 

airworthiness directive (AD) for certain 

Rockwell Collins TDR–94 and TDR–94D 

Mode select (S) transponders that are 

installed on airplanes. This proposed 

AD was prompted by instances where 

the TDR–94 and TDR–94D Mode S 

transponders did not properly respond 

to Mode S Only All-Call interrogations 

when the airplane transitioned from a 

ground to airborne state. This proposed 

AD would require inspecting the setting 

of the airplane type code category 

strapping and require either modifying 

the airplane type code category setting 

or installing the software upgrade to 

convert the affected transponders to the 

new part number. We are proposing this 

AD to correct the unsafe condition on 

these products. 

DATES: We must receive comments on 

this proposed AD by July 7, 2014. 

ADDRESSES: You may send comments, 

using the procedures found in 14 CFR 

11.43 and 11.45, by any of the following 

methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov. Follow the 

instructions for submitting comments. 

• Fax: 202–493–2251. 

• Mail: U.S. Department of 

Transportation, Docket Operations, M– 

30, West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue SE., 

Washington, DC 20590. 

• Hand Delivery: Deliver to Mail 

address above between 9 a.m. and 5 

p.m., Monday through Friday, except 

Federal holidays. 

For service information identified in 

this proposed AD, contact Rockwell 

Collins, Inc., Collins Aviation Services, 

350 Collins Road NE., M/S 153–250, 

Cedar Rapids, IA 52498–0001; 

telephone: 888–265–5467 (U.S.) or 319– 

265–5467; fax: 319–295–4941 (outside 

U.S.); email: 

techmanuals@rockwellcollins.com; 

Internet: http:// 

www.rockwellcollins.com/ 

Services_and_Support/ 

Publications.aspx. You may review this 

referenced service information at the 

FAA, Small Airplane Directorate, 901 

Locust, Kansas City, Missouri 64106. 

For information on the availability of 

this material at the FAA, call (816) 329– 

4148. 

Examining the AD Docket 

You may examine the AD docket on 

the Internet at http:// 

www.regulations.gov by searching for 

and locating Docket No. FAA–2014– 

0326; or in person at the Docket 

Management Facility between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. The AD docket 

contains this proposed AD, the 

regulatory evaluation, any comments 

received, and other information. The 

street address for the Docket Office 

(phone: 800–647–5527) is in the 

ADDRESSES section. Comments will be 

available in the AD docket shortly after 

receipt. 

FOR FURTHER INFORMATION CONTACT: Ben 

Tyson, Aerospace Engineer, Wichita 

Aircraft Certification Office, FAA, 1801 

Airport Road, Room 100, Wichita, 

Kansas 67209; phone: 316–946–4174; 

fax: 316–946–4107; email: 

ben.tyson@faa.gov. 

SUPPLEMENTARY INFORMATION: 

Comments Invited 

We invite you to send any written 

relevant data, views, or arguments about 

this proposal. Send your comments to 

an address listed under the ADDRESSES

section. Include ‘‘Docket No. FAA– 

2014–0326; Directorate Identifier 2013– 

CE–051–AD’’ at the beginning of your 

comments. We specifically invite 

comments on the overall regulatory, 

economic, environmental, and energy 

aspects of this proposed AD. We will 

consider all comments received by the 

closing date and may amend this 

proposed AD because of those 

comments. 

We will post all comments we 

receive, without change, to http:// 

www.regulations.gov, including any 

personal information you provide. We 

will also post a report summarizing each 

substantive verbal contact we receive 

about this proposed AD. 

Discussion 

We were notified that Bombardier 

CL604 airplanes in Eurocontrol airspace 

were not transmitting the appropriate 

Mode S replies. In at least one case, the 

flight crews switched to the other 

installed transponder, resulting in 

normal operation. Rockwell Collins, Inc. 

confirmed that other types of airplane 

could exhibit this same unsafe 

condition. As a result of the issue in 

Eurocontrol airspace, EASA issued 

Airworthiness Directive 2010–0003R1, 

effective date January 11, 2010. 

The TDR–94 and TDR–94D Mode S 

transponder internal software does not 

correctly implement the air/ground 

override function when the airplane 

type code strapping is set to any value 

other than (1) or (0) and the airplane 

rotation speed is greater than 100 knots. 

The error in the air/ground override 

function inhibits the Mode S Only AllCall replies. This condition, if not 

corrected, could result in increased pilot 

and air traffic controller workload as 

well as reduced separation of airplanes. 

Relevant Service Information 

We reviewed Rockwell Collins, Inc. 

Service Information Letter 07–2, 

Revision No. 1, 523–0810069–101000, 

dated September 2, 2008; Service 

Bulletin 505, 523–0816034–001000, 

dated September 2, 2008; Service 

Bulletin 507, 523–0816423–301000, 

dated Revision 3, dated December 5, 

2011; Service Bulletin 508, 523– 

0817821–001000, dated September 16, 

2009; and Service Bulletin 509, 523– 

0817822–001000, dated September 16, 

2009. The service information describes 

procedures for verifying the airplane 

type category strapping is correctly set 

and installing the software upgrade to 

convert the affected transponders to the 

new part number. 

FAA’s Determination 

We are proposing this AD because we 

evaluated all the relevant information 

and determined the unsafe condition 

described previously is likely to exist or 

develop in other products of the same 

type design. 

Proposed AD Requirements 

This proposed AD would require 

inspecting the setting of the airplane 

type code category strapping and 

require either modifying the airplane 

type code category setting or installing 

the software upgrade to convert the 

affected transponders to the new part 

number. 

Costs of Compliance 

We estimate that this proposed AD 

affects 8,000 products installed on 

airplanes of U.S. registry. 

We estimate the following costs to 

comply with this proposed AD: 

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Federal Register / Vol. 79, No. 99 / Thursday, May 22, 2014 / Proposed Rules 29385 

ESTIMATED COSTS

Action Labor cost Parts cost Cost per 

product 

Cost on U.S. 

operators 

Inspect the setting of the airplane type category 

strapping.

1 work-hour × $85 per 

hour = $85.

Not applicable .................. $85 $680,000 

We estimate the following costs to do 

any necessary corrections that would be 

required based on the results of the 

proposed inspection. We have no way of 

determining the number of airplane that 

might need these corrections: 

ON-CONDITION COSTS

Action Labor cost Parts cost Cost per product 

Modify the airplane type code category strapping .......... 1 work-hour × $85 per 

hour = $85.

Not applicable .................... $85. 

Convert the part number of the equipment ..................... 2 work-hours × $85 per 

hour = $170.

See conversion parts cost 

table.

Varies depending on applicable part number or 

service bulletin. 

CONVERSION PARTS COST TABLE—TDR–94 AND TDR–94D 

Starting part number Service 

Bulletin 505 

Service 

Bulletin 507 

Service 

Bulletin 508 

Service 

Bulletin 509 

–007 ................................................................................................................. N/A $5,886 $12,636 $18,465 

–008 ................................................................................................................. $2,323 5,886 3,414 9,429 

–108 ................................................................................................................. 2,323 N/A N/A 6,816 

–207 ................................................................................................................. N/A 5,886 9,234 15,057 

–308 ................................................................................................................. 2,323 5,886 3,414 9,429 

–309 ................................................................................................................. N/A 5,886 3,414 9,429 

–310 ................................................................................................................. N/A N/A N/A 6,183 

–408 ................................................................................................................. 2,323 N/A N/A 3,414 

–409 ................................................................................................................. N/A N/A N/A 3,414 

Authority for This Rulemaking 

Title 49 of the United States Code 

specifies the FAA’s authority to issue 

rules on aviation safety. Subtitle I, 

section 106, describes the authority of 

the FAA Administrator. Subtitle VII: 

Aviation Programs, describes in more 

detail the scope of the Agency’s 

authority. 

We are issuing this rulemaking under 

the authority described in Subtitle VII, 

Part A, Subpart III, Section 44701: 

‘‘General requirements.’’ Under that 

section, Congress charges the FAA with 

promoting safe flight of civil aircraft in 

air commerce by prescribing regulations 

for practices, methods, and procedures 

the Administrator finds necessary for 

safety in air commerce. This regulation 

is within the scope of that authority 

because it addresses an unsafe condition 

that is likely to exist or develop on 

products identified in this rulemaking 

action. 

Regulatory Findings 

We determined that this proposed AD 

would not have federalism implications 

under Executive Order 13132. This 

proposed AD would not have a 

substantial direct effect 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. 

For the reasons discussed above, I 

certify this proposed regulation: 

(1) Is not a ‘‘significant regulatory 

action’’ under Executive Order 12866, 

(2) Is not a ‘‘significant rule’’ under 

the DOT Regulatory Policies and 

Procedures (44 FR 11034, February 26, 

1979), 

(3) Will not affect intrastate aviation 

in Alaska, and 

(4) 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. 

List of Subjects in 14 CFR Part 39 

Air transportation, Aircraft, Aviation 

safety, Incorporation by reference, 

Safety. 

The Proposed Amendment 

Accordingly, under the authority 

delegated to me by the Administrator, 

the FAA proposes to amend 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. The FAA amends § 39.13 by adding 

the following new airworthiness 

directive (AD): 

Rockwell Collins, Inc.: Docket No. FAA– 

2014–0326; Directorate Identifier 2013– 

CE–051–AD. 

(a) Comments Due Date 

We must receive comments by July 7, 2014. 

(b) Affected ADs 

None. 

(c) Applicability 

(1) This AD applies to the following 

Rockwell Collins, Inc. part number (P/N) 

Mode S transponders that are known to be 

installed on but not limited to the airplanes 

listed in paragraphs (c)(2)(i) through 

(c)(2)(xiv) of this AD, except for those 

airplanes listed in paragraphs (c)(3)(i) 

through (c)(3)(vi) of this AD, that have been 

modified in-production or in-service: 

(i) TDR–94: CPN 622–9352–008, 622– 

9352–108, 622–9352–308, 622–9352–408; 

and 

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29386 Federal Register / Vol. 79, No. 99 / Thursday, May 22, 2014 / Proposed Rules 

(ii) TDR–94D: CPN 622–9210–008, 622– 

9210–108, 622–9210–308, 622–9210–408. 

(2) The products listed in paragraphs 

(c)(1)(i) and (c)(1)(ii) of this AD may be 

installed on but not limited to the following 

airplanes featuring weight-on wheels input to 

the transponder, certificated in any category: 

(i) ATR42 and ATR72; 

(ii) Bombardier (Canadair) CL–600–2B16 

(604 Variant); 

(iii) Bombardier CL–600–2B19 (RJ100 and 

RJ200); 

(iv) Cessna 525, serial numbers (S/N) 525– 

0600 through 525–0684 (CJ1); 

(v) Cessna 525A, S/N 525A–0300 through 

525A–0438 (CJ2); 

(vi) Cessna 525B, S/N 525B–0001 through 

525B–0293 (CJ3); 

(vii) Cessna 560, S/N 560–0751 through 

560–0802 (Citation Encore); 

(viii) Cessna 560XL, S/N 560–6001 and 

subsequent; 

(ix) Dassault Aviation Mystere-Falcon 50; 

(x) Dassault Aviation Mystere-Falcon 900; 

(xi) Dassault Aviation Falcon 2000; 

(xii) Dassault Aviation Falcon 2000EX; 

(xiii) Piaggio Aero Industries P.180 (Avanti 

and Avanti II); and 

(xiv) SAAB 2000. 

(3) This AD action does not apply to the 

excepted airplane models, identified in 

paragraphs (c)(3)(i) through (c)(3)(vi) of this 

AD, that have been modified in-production 

or in-service. They do not have the unsafe 

condition described in this AD. 

(i) Dassault airplanes that have been 

modified in-service or in-production 

following the applicable Dassault Aviation 

service information as listed in table 1 of 

paragraph (c)(3)(i) of this AD. 

TABLE 1 OF PARAGRAPH (C)(3)(i) OF THIS AD: EXCEPTED DASSAULT AIRPLANES

Airplane models Service Bulletin Modification(s) 

Mystere-Falcon 50 ............................................. F50–457 ........................................................... M2966 and M2968. 

Mystere-Falcon 900 ........................................... F900–354 ......................................................... M3896. 

Falcon 900EX ..................................................... F900EX–239 .................................................... M3896. 

Falcon 2000 ....................................................... F2000–312 ....................................................... M2624 and M2632. 

Falcon 2000EX ................................................... F2000EX–043 .................................................. M2624. 

(ii) Model ATR 42 airplanes or ATR 72 

airplanes that had P/N 622–9210–108 

transponders installed in production using 

ATR modification 05614 or installed inservice using ATR Service Bulletin ATR42– 

34–0167 or ATR Service Bulletin ATR72–34– 

1094, as applicable. 

(iii) SAAB Model 2000 airplanes that had 

P/N 622–9210–008 transponders installed in 

production using SAAB modifications 6231, 

6243, and 6249 or installed in-service using 

SAAB Service Bulletins 2000–34–066, 2000– 

34–072, and 2000–34–076. 

(iv) Bombardier Aerospace (Canadair) 

airplanes Model CL–600–2B16 (604 Variant) 

that had P/N 622–9210–008 transponders 

installed and incorporated the corrective 

actions recommended in the Bombardier 

Advisory Wire AW 604–34–0078 using the 

instructions in Bombardier Aerospace 

Service Bulletin 604–34–054 (drawing 604– 

70482 Engineering Order, Revison D–1) or 

using a service request for product support. 

Bombardier Aerospace (Canadair) airplanes 

Model CL–600–2B19 (RJ100 and RJ200) that 

had P/N 622–9210–008 transponders 

installed in production using Bombardier 

Aerospace Modification TC601R16789 or in 

service using Bombardier Aerospace Service 

Bulletin 601R–34–142 (Modification 

TC601R16790). 

(v) Cessna Aircraft Company Models 525, 

525A, and 525B airplanes that had P/N 622– 

9352–008 transponders installed in 

production using Cessna Engineering Change 

Records (ECRs) 55298, 58654, and 59567; and 

Model 525B airplanes that had P/N 622– 

9352–008 transponders installed in service 

using Cessna Aircraft Company Service 

Bulletin SB525B–34–03 or SB525B–34–08. 

Cessna Aircraft Company Models 525, 525A, 

525B, 560, and 560XL airplanes that had P/ 

N 622–9210–008 transponders installed in 

production using Cessna ECRs 55298, 58654, 

59567, 56135, and 58032; and Model 525B 

airplanes that had P/N 622–9210–008 

transponders installed in service using 

Cessna Service Bulletin SB525B–34–03 or 

SB525B–34–08. 

(vi) Piaggio Aero Industries Model P.180 

(Avanti) airplanes that had P/N 622–9210– 

008 transponders installed in production 

using Piaggio modification 80–0773 or in 

service using Piaggio Service Bulletin SB– 

80–0227. Piaggio Aero Industries Model 

P.180 (Avanti II) airplanes that had P/N 622– 

9210–008 transponders installed in 

production using Piaggio modification 80– 

0588 and 80–0598. 

(d) Subject 

Joint Aircraft System Component (JASC)/ 

Air Transport Association (ATA) of America 

Code 34, Navigation. 

(e) Unsafe Condition 

This AD was prompted by instances where 

the TDR–94 and TDR–94D Mode S 

transponders did not properly respond to 

Mode S Only All-Call interrogations when 

the airplane transitioned from a ground to 

airborne state. We are issuing this AD to 

detect and correct Mode S transponders that 

do not respond correctly to Mode S Only AllCall interrogations, which could result in 

increased pilot and air traffic controller 

workload as well as reduced separation of 

airplanes. 

(f) Compliance 

Comply with this AD within the 

compliance times specified, unless already 

done. 

(g) Inspection 

Within the next 2 years after the effective 

date of this AD, inspect the airplane type 

code category strapping setting for a value of 

zero (0) or one (1) following Rockwell 

Collins, Inc. Service Information Letter 07–2, 

523–0810069–101000, Revision 1, dated 

September 2, 2008. If the airplane type code 

category strapping is set to a value of zero (0) 

or one (1), no further action is required by 

this AD. 

(h) Modification 

If the airplane type code category strapping 

is not set to a value of zero (0) or one (1), 

within two years after the effective date of 

this AD, do the actions required in either 

paragraph (h)(1) or (h)(2) of this AD. 

(1) Modify the airplane type code category 

strapping setting to a value of zero (0) or one 

(1) following Rockwell Collins, Inc. Service 

Information Letter 07–2, 523–0810069– 

101000, Revision 1, dated September 2, 2008. 

(2) Install a software upgrade to convert the 

part numbers of the transponders to the new 

part numbers using the following service 

information, as applicable: 

Note 1 to paragraph (h)(2) of this AD: More 

than one of the bulletins may apply to your 

particular P/N transponder, but each bulletin 

brings different capabilities and associated 

costs. We recommend reviewing each 

bulletin to determine the optimal choice for 

your installation. 

(i) Service Bulletin 505, 523–0816034– 

001000, dated September 2, 2008; 

(ii) Service Bulletin 507, 523–0816423– 

301000, Revision 3, dated December 5, 2011; 

(iii) Service Bulletin 508, 523–0817821– 

001000, dated September 16, 2009; or 

(iv) Service Bulletin 509, 523–0817822– 

001000, dated September 16, 2009. 

(i) Alternative Methods of Compliance 

(AMOCs) 

(1) The Manager, Wichita Aircraft 

Certification Office (ACO), FAA, has the 

authority to approve AMOCs for this AD, if 

requested using the procedures found in 14 

CFR 39.19. In accordance with 14 CFR 39.19, 

send your request to your principal inspector 

or local Flight Standards District Office, as 

appropriate. If sending information directly 

to the manager of the ACO, send it to the 

attention of the person identified in 

paragraph (j)(1) of this AD. 

(2) Before using any approved AMOC, 

notify your appropriate principal inspector, 

or lacking a principal inspector, the manager 

of the local flight standards district office/ 

certificate holding district office. 

(j) Related Information 

(1) For more information about this AD, 

contact Ben Tyson, Aerospace Engineer, 

Wichita ACO, FAA, 1801 Airport Road, 

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Federal Register / Vol. 79, No. 99 / Thursday, May 22, 2014 / Proposed Rules 29387 

Room 100, Wichita, Kansas 67209; phone: 

316–946–4174; fax: 316–946–4107; email: 

ben.tyson@faa.gov. 

(2) For service information identified in 

this AD, contact Rockwell Collins, Inc., 

Collins Aviation Services, 350 Collins Road 

NE., M/S 153–250, Cedar Rapids, IA 52498– 

0001; telephone: 888–265–5467 (U.S.) or 

319–265–5467; fax: 319–295–4941 (outside 

U.S.); email: 

techmanuals@rockwellcollins.com; Internet: 

http://www.rockwellcollins.com/ 

Services_and_Support/Publications.aspx. 

You may review this referenced service 

information at the FAA, Small Airplane 

Directorate, 901 Locust, Kansas City, 

Missouri 64106. For information on the 

availability of this material at the FAA, call 

(816) 329–4148. 

Issued in Kansas City, Missouri, on May 

16, 2014. 

Earl Lawrence, 

Manager, Small Airplane Directorate, Aircraft 

Certification Service. 

[FR Doc. 2014–11846 Filed 5–21–14; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 866 

[Docket No. FDA–2014–N–0440] 

Microbiology Devices; Reclassification 

of Influenza Virus Antigen Detection 

Test Systems Intended for Use Directly 

With Clinical Specimens 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed order. 

SUMMARY: The Food and Drug 

Administration (FDA) is proposing to 

reclassify antigen based rapid influenza 

virus antigen detection test systems 

intended to detect influenza virus 

directly from clinical specimens that are 

currently regulated as influenza virus 

serological reagents from class I into 

class II with special controls and into a 

new device classification regulation. 

DATES: Submit either electronic or 

written comments on the proposed 

order by August 20, 2014. See section XI 

for the proposed effective date of any 

final order that may publish based on 

this proposed order. 

ADDRESSES: You may submit comments, 

identified by Docket No. FDA–2014–N– 

0440, by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions in the 

following ways: 

• Mail/Hand delivery/Courier (for 

paper submissions): Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

Instructions: All submissions received 

must include the Agency name and 

Docket No. FDA–2014–N–0440 for this 

rulemaking. All comments received may 

be posted without change to http:// 

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

of the SUPPLEMENTARY INFORMATION

section. 

Docket: For access to the docket to 

read background documents or 

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: 

Stefanie Akselrod, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5517, Silver Spring, 

MD 20993–0002, 301–796–6188. 

SUPPLEMENTARY INFORMATION: 

I. Regulatory Authorities 

The Federal Food, Drug, and Cosmetic 

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

Medical Device Amendments of 1976 

(the 1976 amendments) (Pub. L. 94– 

295), the Safe Medical Devices Act of 

1990 (Pub. L. 101–629), and the Food 

and Drug Administration Modernization 

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

the Medical Device User Fee and 

Modernization Act of 2002 (Pub. L. 107– 

250), the Medical Devices Technical 

Corrections Act (Pub. L. 108–214), the 

Food and Drug Administration 

Amendments Act of 2007 (Pub. L. 110– 

85), and the Food and Drug 

Administration Safety and Innovation 

Act (FDASIA) (Pub. L. 112–144), among 

other amendments, established a 

comprehensive system for the regulation 

of medical devices intended for human 

use. Section 513 of the FD&C Act (21 

U.S.C. 360c) established three categories 

(classes) of devices, reflecting the 

regulatory controls needed to provide 

reasonable assurance of their safety and 

effectiveness. The three categories of 

devices are class I (general controls), 

class II (special controls), and class III 

(premarket approval). 

Under the FD&C Act, FDA clears or 

approves the three classes of medical 

devices for commercial distribution in 

the United States through three 

regulatory processes: Premarket 

approval (PMA), product development 

protocol, and premarket notification (a 

premarket notification is generally 

referred to as a ‘‘510(k)’’ after the section 

of the FD&C Act where the requirement 

is found). The purpose of a premarket 

notification is to demonstrate that the 

new device is substantially equivalent 

to a legally marketed predicate device. 

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

a device is substantially equivalent if it 

has the same intended use and 

technological characteristics as a 

predicate device, or has different 

technological characteristics but data 

demonstrate that the new device is as 

safe and effective as the predicate 

device and does not raise different 

issues of safety or effectiveness. 

FDA determines whether new devices 

are substantially equivalent to 

previously offered devices by means of 

premarket notification procedures in 

section 510(k) of the FD&C Act (21 

U.S.C. 360(k)) and part 807 of the 

regulations (21 CFR part 807). Section 

510(k) of the FD&C Act and the 

implementing regulations in part 807, 

subpart E, require a person who intends 

to market a medical device to submit a 

premarket notification submission to 

FDA before proposing to begin the 

introduction, or delivery for 

introduction into interstate commerce, 

for commercial distribution of a device 

intended for human use. 

In accordance with section 513(f)(1) of 

the FD&C Act, devices that were not in 

commercial distribution before May 28, 

1976, the date of enactment of the 1976 

amendments, generally referred to as 

postamendment devices, are classified 

automatically by statute into class III 

without any FDA rulemaking process. 

These devices remain in class III and 

require premarket approval, unless FDA 

classifies the device into class I or class 

II by issuing an order finding the device 

to be substantially equivalent, in 

accordance with section 513(i) of the 

FD&C Act, to a predicate device that 

does not require premarket approval or 

the device is reclassified into class I or 

class II. The Agency determines whether 

new devices are substantially equivalent 

to predicate devices by means of 

premarket notification procedures in 

section 510(k) of the FD&C Act and part 

807 of FDA’s regulations. 

Section 513(f)(2) of the FD&C Act 

establishes procedures for ‘‘de novo’’ 

risk-based review and classification of 

postamendment devices automatically 

classified into class III by section 

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