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FDA/CDRH Webinar

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Overview of the Final 

Order calling for PMAs for 

AEDs

Linda Ricci

Chief, Cardiac Diagnostic Devices Branch

Division of Cardiovascular Devices 

Office of Device Evaluation 

Center for Devices and Radiological Health
Purpose 

The purpose of this webinar is to 

provide an overview of the final 

order focusing on what is expected 

from AED device and accessory 

manufacturers for premarket 

approval submissions
Agenda

• Overview of the Final Order

• New devices or accessories

• AED devices currently distributed

• AED accessories currently distributed

• Next steps
Final Order Summary

The Food and Drug Administration is issuing a final 

order to require the filing of premarket approval 

applications (PMA) for automated external defibrillator 

(AED) systems, which consist of an AED and those AED 

accessories necessary for the AED to detect and 

interpret an electrocardiogram and deliver an electrical 

shock. 

• http://www.gpo.gov/fdsys/pkg/FR-2015-02-

03/pdf/2015-02049.pdf 
Final Order Overview

• What is included in the order:

– AED device

– Necessary AED accessories such as:

• Pad electrode

• Battery

• Adapter

• Hardware key for pediatric use
Final Order Overview

• What does this mean?

– All new devices and accessories require a PMA approval prior to 

beginning distribution. 

– In order to continue to distribute AED devices that were cleared 

through the 510(k) process, an Intent to File and a PMA is required to 

be submitted within the timeline specified in the order.

– In order to continue to distribute necessary AED accessories that were 

cleared through the 510(k) process, a PMA is required to be submitted 

within the timeline specified in the order.

 
New Devices

• Devices for which a 510(k) clearance was not issued

– Must receive a PMA approval before the device can be legally 

marketed. 

• Accessories for which a 510(k) clearance was not 

issued

– Must receive a PMA approval before the device can be legally 

marketed. 
Currently Marketed AED devices

• Intent to File

– Must be submitted within 90 days from the date of the final 

order. 

– Provided formally to the agency. 

– Must include a list of all devices (including model numbers and 

510(k) numbers) for which a PMA will be sought 

– Intent to file is only needed for currently marketed AED devices 

(not needed for accessories).

– For specific models of devices identified in the intent to file for 

which a PMA will be submitted, distribution of those models 

can continue until a PMA is submitted but not longer than 18 

months from the date of the final order.

– For devices for which an Intent to File will not be submitted, 

distribution must stop within 90 days from the date of the final 

order. 
Currently Marketed AED devices cont.

• PMA

– For devices identified in the Intent to File, the PMA must be 

submitted within 18 months from the date of the final order.

– Multiple Public Access devices may be submitted in a single PMA.

– Multiple Professional devices may be submitted in a single PMA.

– Necessary accessories may be submitted within the PMA for the 

AED device.

– For devices included in the PMA, distribution can continue while 

PMA is under review. Distribution will need to cease if a not 

approvable or denial decision is issued.
Currently Marketed AED devices cont.

If a notice of intent to file a PMA for a currently marketed AED 

device is not submitted within 90 days of the effective date of the 

final order or a PMA is not approved, then the manufacturer must 

cease distribution or the device will be deemed to be adulterated 

within the meaning of section 501(f)(1)(A) of the FD&C Act (21 

U.S.C. 351(f)(1)(A)), and subject to seizure and condemnation 

under section 304 of the FD&C Act (21 U.S.C. 334) if its distribution 

continues.
Currently Marketed AED accessories 

• PMA

– If not included in the AED device PMA, a separate PMA must be 

submitted within 5 years from the date of the final order.

– For devices included in a PMA (either a separate PMA or as part 

of the AED device PMA), distribution can continue while PMA is 

under review. Distribution will need to cease if a not 

approvable or denial decision is issued.
Timeline - Summary

Currently Marketed Devices and Accessories 

• Currently Marketed AED devices and accessories Timetable for Which 

FDA Does Not Intend to 

Enforce Compliance 

(days or months after 

effective date of 

order) 

Distribution Period

(months after effective date of 

order)

Intent to 

File a PMA

AEDs - 90 days

Accessories (N/A)

AEDs included in an intent to file: 

 18 months 

AEDs not included in intent to file: 

 90 days

File a PMA AEDs- 18 months

Accessories -60 months

Until a not approvable decision or 

denial decision letter is issued; can 

continue distribution if an approval 

order is issued. 
Next Steps

• Manufacturers 

– File Intent to file for existing devices (AED devices only) 

followed by PMA (within 18 months of the date of the order)

– For those accessories that you intend to continue to market, 

file a PMA (within 5 years of the date of the order)

– File a PMA for any new devices or accessories

– Use pre-submission process to obtain specific feedback from 

the agency.

• Device Users

– Continue to use devices as needed

– Continue to maintain devices per manufacturers instructions
Questions? 

Division of Industry and Consumer Education: 

DICE@fda.hhs.gov

Slide Presentation, Transcript and Webinar 

Recording will be available at:

http://www.fda.gov/training/cdrhlearn

Under Heading “Specialty Technical Topics”