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Complexity Categorization of 

IVDs According to CLIA

Program Updates

March 18, 2014

Don St. Pierre

Deputy Director, Office of In Vitro 

Diagnostics and Radiological Health
Outline 

• What has or is changing

– Administrative Tracking Mechanisms

– MDUFA III Commitments

– Guidance for CLIA Administrative Procedures

• What changes mean for stakeholders

– Industry Sponsors

– Clinical Labs and CMS

• CLIA Background

3
Background

• 1988: Clinical Laboratory Improvement Amendments 

(CLIA) established quality standards for all laboratory 

testing to ensure accuracy, reliability and timeliness 

of patient test results regardless of where the test 

was performed

• 1992: Final Regulations

4
Background (continued)

• 1999: FR Notice transferring responsibility for 

categorization from CDC to FDA/CDRH

• 2008: FDA issued 2 separate guidance documents 

– Administrative Procedures for CLIA Categorizations 

– Recommendations on CLIA Waiver Applications

• 2012: FDASIA/MDUFA III 

– instituted review goals for Waiver by Application and

– established a Dual 510(k) Waiver by Application 

submission pathway 5
What gets categorized?

1. IVDs approved/cleared by CDRH/OIR*

2. IVDs approved/cleared/ licensed by CBER*

3. IVDs exempt from premarket review*

4. Letters reissued for name and/or distributor changes

5. IVDs that are legally marketed and for which the 

sponsor is seeking a waiver categorization*

6

*Reference: 

64 FR 73561, 

Dec 30, 1999
How are IVDs categorized?

• Legally marketed IVDs (i.e., cleared, approved, 

licensed, or exempt) are categorized: 

– as high or moderate complexity based on an objective 

scoring system; or 

– as waived by regulation (42 CFR 493.15); or 

– as waived by clearance/approval for over-the-counter use

• FDA also considers applications requesting waiver 

categorizations of legally marketed IVDs (called 

Waiver by Application) based on clinical data that 

demonstrate a test is accurate and poses an 

insignificant risk of erroneous results 7
Outline 

• CLIA Background

• What changes mean for stakeholders

– Industry Sponsors

– Clinical Labs and CMS

• What has or is changing

– Administrative Tracking Mechanisms

– MDUFA III Commitments (implemented 2012)

– Guidance for CLIA Administrative Procedures

8
9

2012:

FDASIA/ 

MDUFA III 

Commitments 

re CLIA Waiver 

by Application

2014:

New CDRH IT 

System with 

New Tracking 

Nomenclature

2014: 

CLIA 

Administrative 

Procedures 

Guidance 

Document

Nomenclature 

described in 

guidance update

IT system 

designed for 

tracking and 

reporting of 

commitments

• Performance goals 

outlined in guidance

• New “Dual” program 

outlined in guidance

2014:

Public 

CLIA 

database

Nomenclature 

reflected in public 

database

What has or is changing?
Today CLIA 

Categorizations 

tracked under:

510(K), PMA, 

HDE, De Novo

BP, BL, BK

X-file

(Xxxxxxx)

510(k) Add-toFile or PMA

supplement

Parent 

Document

Type of CLIA 

Categorization

Devices Approved 

/ Cleared / 

Licensed by CBER

Pre-Market Review 

Exempt Devices

Name Changes 

(e.g., name, 

distributor)

Devices Approved 

/ Cleared by 

CDRH

Kxxxxxx, 

Pxxxxxx, 

Hxxxxxx

BPxxxxxx,

BLxxxxxx,

BKxxxxxx

CRxxxxxx

Kxxxxxx, 

Pxxxxxx, 

Hxxxxxx,

On March 21th

2014 CLIA will be 

filed as:

CRxxxxxx

CRxxxxxx

CRxxxxxx

CRxxxxxx

What is changing: 

Administrative Tracking Mechanisms
Today CLIA 

Waiver By 

Application 

tracked under:

510(k) Add-toFile or PMA

supplement

BP, BL, BK

X-file

(Xxxxxxx)

Type of CLIA 

Waiver by 

Application

Devices Approved 

/ Cleared / 

Licensed by CBER

Pre-Market Review 

Exempt Devices

Devices Approved 

/ Cleared by 

CDRH

On March 21th

2014 CLIA will be 

filed as:

CWxxxxxx

CWxxxxxx

CWxxxxxx

Parent 

Document

Kxxxxxx, 

Pxxxxxx, 

Hxxxxxx

BPxxxxxx,

BLxxxxxx,

BKxxxxxx

CWxxxxxx

Dual 510(k) and 

CLIA Waiver by 

Application

Manually CWxxxxxx Kxxxxxx

What is changing: 

Administrative Tracking Mechanisms
• Performance goals for CLIA Waiver by Application

(i.e., IVDs that are legally marketed and for which the 

sponsor is seeking a waiver categorization)

– FDA will engage in a substantive interaction within 90 days

– FDA will issue a decision for 95% within 180* FDA days

12

What has changed: 

MDUFA III Commitments

*330 if advisory panel review is required
• New Dual 510(k) CLIA Waiver by Application (Dual) 

program and associated performance goals

– Requires Pre-Submission 

– FDA will engage in a substantive interaction within 90 days

– FDA will issue a decision for 90% within 210 FDA days

13

What has changed: 

MDUFA III Commitments
• “To provide greater transparency, FDA will issue 

guidance regarding review and management 

expectations throughout the entire submission review 

process.”

– Addressed by updating existing Guidance on 

“Administrative Procedures for CLIA Categorization” to 

include review and management expectations for CLIA 

Waiver by Application and Dual review processes

14

What has changed: 

MDUFA III Commitments
What is changing:

Updates to Guidance

• Categorizations

– Explains when a “CR” number will be assigned

– Includes target categorization timeframes

– Includes instructions for submitting requests for multiple 

categorizations due to name/distributor changes across 

multiple IVDs in spreadsheet format 

• Per current policy/procedures

• Waiver by Applications

– Explains when a “CW” number will be assigned

– Includes review and management expectations throughout 

the entire submission process 15
Review/mgmt expectations for Waiver by Application

1. Submission should be sent to CDRH with:

– reference to cleared/approved marketing application; will not be 

accepted if device is under premarket review

– voluntary eCopy to expedite process

2. FDA will notify sponsor of CW tracking number

3. FDA will complete substantive review of initial submission 

within 90 days and notify sponsor of:

– A request for Additional Information (puts file on hold), 

– A plan to Proceed Interactively (without placing file on hold), or 

– Waiver granted. 16

What is changing:

Updates to Guidance
Review/mgmt expectations for Waiver by Application

4. FDA will review additional information (received via 

supplement responding to request for additional information or 

via interactive review) and notify sponsor within 180 total FDA 

days of:

– Waiver Granted, or

– Waiver Denied.

5. FDA will post waiver categorization in public CLIA database 

upon notification of Waiver Granted

17

What is changing:

Updates to Guidance
Review/mgmt expectations for Duals

1. Submission should be sent to CDRH with:

– reference to the Pre-submission during which dual pathway was 

discussed

– the complete 510(k) and waiver application in a single submission; can 

not be staged or modular

– mandatory eCopy

2. FDA will notify sponsor of CW (and K) tracking numbers 

3. FDA will follow 510(k) RTA policies per Guidance

18

What is changing:

Updates to Guidance
Review/mgmt expectations for Duals 

4. FDA will complete substantive review of initial submission 

within 90 days and notify sponsor of:

– A request for Additional Information (puts file on hold), 

– A plan to Proceed Interactively (without placing file on hold), or 

– SE and Waiver granted.

5. FDA will review additional information (received via 

supplement responding to request for additional information 

and/or via interactive review) and notify sponsor within 210 

total FDA days of:

– SE and Waiver Granted, or

– NSE and Waiver Denied. 19

What is changing:

Updates to Guidance
Review/mgmt expectations for Duals 

6. FDA will post waiver categorization in public CLIA database 

upon notification of Waiver Granted

20

What is changing:

Updates to Guidance
• No changes to scientific review process; therefore:

– “This guidance does not specifically address the recommended content 

of CLIA waiver applications.”

– “For additional information regarding the data necessary to support a 

CLIA Waiver by Application, refer to the guidance entitled 

‘Recommendations for CLIA Waiver applications’” 

• Sponsors may submit Pre-Submissions to request feedback on 

planned protocols or study designs to support CLIA waiver 

– Strongly encouraged for all CWs; required for Duals

– Enables discussion of valuable device-specific feedback 

21

What is changing:

Updates to Guidance
Outline 

• CLIA Background

• What has or is changing

– Administrative Tracking Mechanisms

– MDUFA III Commitments

– Guidance for CLIA Administrative Procedures

• What changes mean for stakeholders

– Industry Sponsors

– Clinical Labs and CMS 22
What this means for Industry Sponsors 

of IVD marketing submissions sent to CDRH 

– Sponsors will receive a pre-market tracking number (e.g., 

K140055, P140003) AND a CLIA categorization record 

tracking number (e.g., CR140032)

• Sponsors will receive acknowledgement letters for each

– If categorization not needed (i.e., for calibrators and controls 

or NSE), sponsors will receive an email closing out the CR 

file without a categorization

– If categorization is needed, sponsors will receive a 

categorization letter via e-mail attachment within 10 days of 

marketing decision

–

23

Categorization will appear in public database with a CR 

“Document” Number and a K/P/H “Parent” Number
24

What this means for Industry Sponsors

of IVD marketing submissions sent to CBER 

– Sponsors will initially receive a marketing tracking number 

only (e.g., BK140048, BP140002, BL140015)

– If a positive marketing decision is reached, CBER will 

automatically forward a request for categorization to CDRH

– Sponsors will receive an acknowledgement letter from 

CDRH with their CR number when the process begins

– Within 30 days, CDRH will issue a categorization letter via email attachment

– Categorization will appear in public database with a CR 

“Document” Number and a BK/BP/BL “Parent” Number
25

What this means for Industry Sponsors

requesting categorization of exempt devices

– Sponsors will receive an acknowledgement letter with CR #

– If the submission is incomplete (i.e., missing package insert) 

or if CDRH believes the device requires premarket review 

(i.e., is not exempt), sponsors will receive an email closing 

out the CR file without a categorization and providing further 

instructions to the sponsor

– Otherwise, CDRH will issue a categorization letter via e-mail 

attachment within 30 days

– Categorization will appear in public database with a CR 

“Document” Number and a blank “Parent” Number
What this means for Industry Sponsors

requesting new categorization letters that reflect 

changes in name and/or distributor

– Sponsors will receive an acknowledgement letter with CR #

– If the submission is incomplete (i.e., missing package insert) 

or if CDRH believes the change requires premarket review, 

sponsors will receive an email closing out the CR file without 

a categorization and providing further instructions to the 

sponsor

– Otherwise, CDRH will issue a categorization letter via e-mail 

attachment within 30 days

–

26

Categorization will appear in public database with a CR 

“Document” Number and a K/P/H/BK/BP/BL “Parent” 

Number
What this means for Industry Sponsors

requesting a Waiver by Application 

– Sponsors will receive an acknowledgement letter with CW #

– If additional information is needed, sponsors will receive an 

email by day 90 which puts the file on hold pending 

submission of additional information

• Sponsors should submit additional information to DCC as a 

supplement to the CW number

– Within 180* total FDA days, sponsors will receive either an 

waiver granted or denial letter via e-mail attachment

–

27

If waiver granted, categorization will appear in public 

database with a CW “Document” Number and a CR or 

marketing application “Parent” Number

*330 if advisory panel review is required
What this means for Industry Sponsors

submitting a Dual 510k & CLIA Waiver by Application

– Sponsor should ensure the following criteria are met:

• Must be preceded by a Pre-Submission during which the dual 

pathway was discussed

• Must be a single submission containing all 510k and Waiver by 

Application required elements 

– may not be staged or modular

– 510k user fee applies

– Mandatory eCopy per 510k requirements

– If the above criteria are met, sponsors will receive two 

acknowledgement letters (CW and K)

– FDA will proceed with one review under one review clock28
29

What this means for Industry Sponsors

submitting a Dual 510k & CLIA Waiver by Application 

– Sponsors will receive either an acceptance or rejection 

notification via e-mail by day 15 (per 510k RTA criteria)

• If rejected, sponsor must submit additional information to DCC as a 

supplement referencing both CW and K numbers

• Single review clock resets to day 0 when a supplement that is 

ultimately accepted is received by DCC

– If after substantive review of the entire submission FDA 

determines additional information is needed, sponsors will 

receive an email by day 90 which puts the CW and K on hold 

pending submission of additional information

• Sponsors should submit additional information to DCC as a 

supplement referencing both the CW and K numbers
30

What this means for Industry Sponsors

submitting a Dual 510k & CLIA Waiver by Application 

– Within 210 total FDA days, sponsors will receive either:

• 510k SE and CLIA Waiver Approval letters via e-mail attachment

• 510k NSE and CLIA Waiver Denial letters via e-mail attachment

– If SE/Approved, categorization will appear in public database 

with a CW “Document” Number and a K “Parent” Number
What this means for Clinical Labs & CMS

Minor changes to CLIA public database

− All information already displayed will continue to be 

displayed in the same format

− New categorizations will include the CW or CR 

tracking number in addition to the marketing 

application number

− Previous categorizations will not be updated to include 

CR or CW numbers

−

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The presence or absence of a CW or CR number has 

no impact on validity of a categorization; these 

numbers are for FDA tracking purposes only
References

• CLIA Administrative Procedures Guidance

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Guidan

ceDocuments/ucm070762.htm

• CLIA Waiver by Application Guidance

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Guidan

ceDocuments/ucm079632.htm

• CLIA public database

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm

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Thank you for participating!

Please send your questions to:

CDRHCLIACoordinator@fda.hhs.gov

CDRHQuestions@fda.hhs.gov

DSMICA@fda.hhs.gov

For more information on the regulation of medical 

devices, visit CDRH Learn and Device Advice

in the Medical Device section of FDA.gov

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