Which Apps Does FDA Regulate?

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Which Apps Does FDA Regulate?

Bradley Merrill Thompson

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Which apps does FDA regulate?

Enforcement Discretion

Topics for Discussion

Pharma Apps

Future Reforms

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Section 201(h) of the Federal Food, Drug, and Cosmetic Act, defines a medical device as:

"... an instrument, apparatus, implement, machine,

contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is ... [either]

intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals ... [or]

intended to affect the structure or any function of the body of man or other animals."

Device Definition

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General Purpose

Flavors of Intended Use

General Health Purpose

Tools Claims Specific

Clinical Claims

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Final Guidance

FDA draws the line between regulated/unregulated

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Regulated Mobile Medical Apps

Mobile Apps subject to Enforcement Discretion Unregulated Mobile Apps

What gets regulated?

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Focus on functionality and risk to patients regardless of platform



Look at what FDA has regulated in the past.

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In 2013 Biosense received “It has come to our attention” letter from FDA

Mobile Medical Apps

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1.

Accessories to a medical device

 Mobile apps that are an “extension” to a medical device by connecting to the device to

 controlling the device

 use in active patient monitoring, or

 analyzing medical device data.

(2015 edition)

Mobile Medical Apps

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Success may depend on accessories

Collegehumor.com

Success may depend on accessories

Collegehumor.com ⁹

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Example: control medical devices

www.blessthisstuff.com

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2.

Functionalities similar to currently regulated medical devices

a. Using special medical attachments b. Using generic attachments

c. Using no attachments

Mobile Medical Apps

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Example

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3.

[CDS]

a. performing patient-specific analysis and

b. providing patient-specific diagnosis, or treatment recommendations.

Mobile Medical Apps

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Example

vomweg.net

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Unregulated Mobile Apps

Regulated Mobile Medical Apps

Mobile Apps subject to Enforcement Discretion

Unregulated Mobile Apps

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1.

Electronic copies of medical textbooks

2.

Educational tools

3.

Facilitate patient access to information

4.

Business operations in healthcare settings (accounting, billing)

5.

Generic aid (e.g. magnifying glass)

Unregulated Mobile Apps 5 categories

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Topics for Discussion

Pharma Apps

Future Reforms

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Mobile Apps subject to Enforcement Discretion

Regulated Mobile Medical Apps

Mobile Apps subject to Enforcement Discretion

Unregulated Mobile Apps

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The Law is Not Always Clear

Ihatepeas.com

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FDA decided to exempt low risk devices, however

 May or may not meet definition of medical device

 May not be forever exempt, but will only change

prospectively and if FDA pursues revision to guidance

 Recommend quality system for some but not others?

Mobile Apps Subject to Enforcement Discretion

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1.

Patient motivators

2.

Patient day-timers

3.

Access to contextually relevant information

4.

Certain telemedicine products

5.

Simple professional calculators

6.

Connections to EHR’s

7.

MDDS

Enforcement Discretion Categories

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Topics for Discussion

Pharma Apps

Future Reforms

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1. Patient information collection and storage 2. Pharmaceutical shopping

3. Research and education

4. Physician management of drug-prescribing information 5. Patient-focused drug administration and compliance

management

6. Clinical decision support, for either patients or professionals

7. Patient testing and assessment 8. Clinical trial management

Types of Pharma Apps

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1. Unregulated 2. Drug labeling

3. Medical device (MMA or CDS) 4. Combination products

Regulatory Categories

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But remember

 FTC

 State regulators

 Lanham Act

 Civil tort

Unregulated by FDA

A/K/A

Heaven on Earth

http://www.farhanadhalla.com/

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 Promotional Labeling

 Used to help sell prescription drugs

 Brochures and booklets

 Mailed materials, including letters to patients

 Videotapes

 Refrigerator magnets, cups, and other giveaways that show a drug's name

 Often must be accompanied by the drug’s prescribing

information

 Must meet many other requirements, including

submission to FDA at time of first use

Drug Labeling

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Apps used for shopping for drugs

 Apps that might help with price comparisons and pharmacy location.

Unregulated Drug Apps Per MMA

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1.

Medication reminders

 help the patient adhere to a predetermined medication dosage schedule

2.

Medication trackers

 used by a patient to track drug intake times

3.

Drug interaction lookup tools

 used for drug-drug interaction or drug-allergy lookup

Drug Apps in Enforcement Discretion

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 Evidence-based clinician order sets tailored for a particular condition, disease, or clinician preference;

 Drug-drug interaction and drug- allergy contraindication alerts to avert adverse drug events;

 Most drug dosing calculations;

 Drug formulary guidelines;

 Reminders for preventative care (e.g. mammography,

colonoscopy, immunizations, etc.);

Enforcement Discretion CDS per FDASIA

 Facilitation of access to

treatment guidelines and other reference material that can

provide information relevant to particular patients;

 Calculation of prediction rules and severity of illness

assessments (e.g., APACHE score, AHRQ Pneumonia

Severity Index, Charlson Index);

 Suggestions for possible diagnoses based on patient- specific information retrieved from a patient’s EHR.

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5. Patient-focused drug administration and compliance management

 Control of medical device used in dispensing drugs, for example controlling an insulin pump

 Work with smart pills or smart injectors to record drug administration to help determine compliance

6. Clinical decision support, for either patients or professionals

 Complex and high risk drug recommendation apps

7. Patient testing and assessment

 Use, for example, a cell phone to perform some direct

physiological measurements such as an audiology test or eye test that could lead to drug treatment

Regulated Pharma Apps

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

21 CFR 3.2(e)

 Single-entity: a product comprised of two or more

regulated components that are physically, chemically or otherwise combined or mixed as a single entity

 Kits: two or more separate products packaged together (e.g., drug and device products)

 Cross-labeled: provided separately but intended for use together where both are required to achieve the intended use and where cross labeling is needed

3 Types of Combination Products

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Topics for Discussion

Pharma Apps

Future Reforms

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Contemplate the network

 No predefined clinical intended use

 Interoperability

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Standalone software that plays clinically significant roles

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Remote site of service

 Home use and mobile type considerations

 Human factors

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Telemedicine type issues

 The impersonal touch

New FDA Regulatory System Requirements: Technology

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Collaboration among IT technical experts, clinicians, medical device developers and scientists of many sorts.

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Virtual development processes

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Even shorter product lifecycles

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Modularization of software

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Easier entry for those not experienced in health

New FDA Regulatory System Requirements: Business Model

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Specific Needed Improvements

Innovation Factor Needed Regulatory Change

1. Cost and timelines for developing products

Clarity and predictability in the pathway

 Classification: I, II or III

2. The accessibility of regulatory requirements to small business

More outreach

 User-friendly web-based information

 Face-to-face educational programs

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New Approach

3. Components for unspecified systems

 Tool intended uses

 Accessory classifications

4. Release of beta software programs Clarification on how investigational

device rules apply to regulated software

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New Approach

5. Frequent incremental

improvements to software

Clear triggers for premarket requirements

6. Key role of standalone software Guidance on

 Premarket data requirements

 Quality system regulation

 Postmarket reporting obligations

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Legislation

MEDTECH Act SOFTWARE Act

Senate House

Carves out several categories of low- risk technology that should not be regulated

Approaches software categorization and regulation from a functional use approach (i.e. what is the software doing)

Administrative or operational support for a healthcare facility; certain EHRs;

lab information systems; etc.

New definitions: medical software and health software

CDS that is transparent New regulatory requirements for medical software. Health software

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Questions?

Bradley Merrill Thompson [email protected]

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