health 2.0 san antonio does your health app need fda approval?

23
Does your Mobile App need FDA Approval? Cynthia Phelps July 16, 2013

Upload: healthedesigns-llc

Post on 28-Nov-2014

1.184 views

Category:

Health & Medicine


2 download

DESCRIPTION

This is a primer to get you thinking about whether or not your mobile health app is going to need FDA approval. If you are just tripping across the internet and found this, check the date, this was given before the FDA finalized their guidelines.

TRANSCRIPT

Page 1: Health 2.0 San Antonio Does your Health APP need FDA Approval?

Does your Mobile App need FDA Approval?

Cynthia Phelps

July 16, 2013

Page 2: Health 2.0 San Antonio Does your Health APP need FDA Approval?

Why does the FDA care?

The FDA is charged with protecting and advancing the public health

Food, Drug and Cosmetic Act of 1938

They regulate:

• Biologics (blood supply), Cosmetics, Drugs, Food, Radiation products, Veterinary Products AND

• Medical Devices

Page 3: Health 2.0 San Antonio Does your Health APP need FDA Approval?

Software FDA regulates

Medical Device Software

Productions System Software

Quality System Software

Electronic Medical Records Software

Clinical Investigations Software

Page 4: Health 2.0 San Antonio Does your Health APP need FDA Approval?

Classification

Products that are clearly NOT

regulated by the FDA

Medical Devices ARE clearly

regulated by the FDA

GREY AREA

Page 5: Health 2.0 San Antonio Does your Health APP need FDA Approval?

Products not regulated

Not regulated:• Hospital Network devices• Data storage devices• Computer Monitors• Software that monitors device malfunction

Page 6: Health 2.0 San Antonio Does your Health APP need FDA Approval?

Regulated Products

Medical Devices ARE regulated

by the FDA

Page 7: Health 2.0 San Antonio Does your Health APP need FDA Approval?

Regulated Products

Grey Area – FDA Guidelines

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

Not yet approved by Congress

Page 8: Health 2.0 San Antonio Does your Health APP need FDA Approval?

What is a Medical Device?

An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or similar or related article, including any component, part, or accessory, which is intended for the diagnosis, of disease, or in the cure, mitigation, treatment, or prevention of disease in man or animals, or intended to affect the structure of function of the body of man or animal.

Page 9: Health 2.0 San Antonio Does your Health APP need FDA Approval?

Is your App a Medical Device?Does your App:Amplify CureAnalyze DetectInterprets DiagnoseAssess ManipulateCalculate MeasureControl ProgramConvert Show trends?

Page 10: Health 2.0 San Antonio Does your Health APP need FDA Approval?

What is the intended use?

Is it a part of an existing medical device?

Is it an extension of a medical device?

Does it diagnose, treat, mitigate, or prevent a disease?

Page 11: Health 2.0 San Antonio Does your Health APP need FDA Approval?

Mobile App Criteria

Extensions of Devices

Transform Apps to Devices

Data Input Devices

Page 12: Health 2.0 San Antonio Does your Health APP need FDA Approval?

Extensions of Devices

Apps that serve as extensions of regulated devices such as those that:

control the devices or

display data from the devices

Analyze data from the devices

Transmit data from these devices

Page 13: Health 2.0 San Antonio Does your Health APP need FDA Approval?

Transform Apps to Devices

Apps that serve to transform mobile platforms into medical control by using:

Attachments

Similar medical device functions

Page 14: Health 2.0 San Antonio Does your Health APP need FDA Approval?

Data Input Devices

Apps allow users to input patient data to:

Output patient specific results, or

Diagnose

Using formulae or algorithms

Page 15: Health 2.0 San Antonio Does your Health APP need FDA Approval?

OMG

Class I Class II Class III

OMG You better have stacks of cash and a boat load of patience

It’s ok, you can ride someone’s coattails

No worries the FDA have bigger fish to fry

The Skinny

Page 16: Health 2.0 San Antonio Does your Health APP need FDA Approval?

Class I Class II Class III

3+ Years

FDA review

PMA application

2+ Months

FDA review

510(k) application

No Formal Review

Register Online

Timeline & Process

Page 17: Health 2.0 San Antonio Does your Health APP need FDA Approval?

Class III

• Highest risk

• Your app qualifies as a medical device

• There is no existing medical device precedent for your App

Page 18: Health 2.0 San Antonio Does your Health APP need FDA Approval?

Class II

• Medium Risk

• You app counts as a medical device

• There are other FDA approved medical devices like yours

Page 19: Health 2.0 San Antonio Does your Health APP need FDA Approval?

Class I

Lowest Risk

Your App is exempt from pre-market notification requirements (510(k)) in the US

MDDS – Medical Device Data Systems (2001)

Category of devices used to transfer, store, convert, or display medical device data.

No diagnosis or treatment

No altering the function or controlling the function of a medical device

Page 20: Health 2.0 San Antonio Does your Health APP need FDA Approval?

Device Classification

Go to:www.fda.gov/medicaldevices

Go to:Search bar, type in Product Classification

Enter a search term in the device field:(Guess using the most general search term possible)

Page 21: Health 2.0 San Antonio Does your Health APP need FDA Approval?

FDA Guidelines not Final

FDA, ONC and FCC are developing a report to be delivered to Congress by September that includes:

“a strategy for coordinating the regulation of health information technology in order to avoid regulatory duplication” and

“recommendations on an appropriate regulatory framework for health information technology, including a risk-based framework.”

Discourage Innovation in Healthcare

Latest news: http://mobihealthnews.com/23305/final-days-of-waiting-for-fda-mobile-medical-app-guidance/

Page 22: Health 2.0 San Antonio Does your Health APP need FDA Approval?

FDA Scorecard

1. Number of FDA regulated medical apps reviewed to date: 100 mobile medical apps to date (June 2013)

2. Time it takes for apps to get through 510(k):  About 67 days for most mobile medical apps.

3. Number of medical apps seeking clearance each year:  FDA only reviews about 20 mobile medical apps each year through its medical device regulatory process.

4. No Class III mobile medical apps yet:  The FDA has not found any mobile medical apps to be Class III medical devices yet.

5. When will the final guidance on mobile medical apps be published? That’s a good question, September. 

Page 23: Health 2.0 San Antonio Does your Health APP need FDA Approval?

HEALTHeDesigns LLC

Cynthia Phelps, PhDFounder

[email protected]