Which Apps Does FDA Regulate?

Transcription

3 Device Definition 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." 2015 EPSTEIN BECKER & GREEN, P.C. ALL RIGHTS RESERVED.. 3

7 Mobile Medical Apps Focus on functionality and risk to patients regardless of platform Look at what FDA has regulated in the past. In 2013 Biosense received It has come to our attention letter from FDA 2015 EPSTEIN BECKER & GREEN, P.C. ALL RIGHTS RESERVED.. 7

8 Mobile Medical Apps 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) 2015 EPSTEIN BECKER & GREEN, P.C. ALL RIGHTS RESERVED.. 8

11 Mobile Medical Apps 2. Functionalities similar to currently regulated medical devices a. Using special medical attachments b. Using generic attachments c. Using no attachments 2015 EPSTEIN BECKER & GREEN, P.C. ALL RIGHTS RESERVED.. 11

16 Unregulated Mobile Apps 5 categories 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) 2015 EPSTEIN BECKER & GREEN, P.C. ALL RIGHTS RESERVED.. 16

18 Mobile Apps subject to Enforcement Discretion Regulated Mobile Medical Apps Mobile Apps subject to Enforcement Discretion Unregulated Mobile Apps 2015 EPSTEIN BECKER & GREEN, P.C. ALL RIGHTS RESERVED.. 18

20 Mobile Apps Subject to Enforcement Discretion 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? 2015 EPSTEIN BECKER & GREEN, P.C. ALL RIGHTS RESERVED.. 20

21 Enforcement Discretion Categories 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 2015 EPSTEIN BECKER & GREEN, P.C. ALL RIGHTS RESERVED.. 21

23 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 2015 EPSTEIN BECKER & GREEN, P.C. ALL RIGHTS RESERVED.. 23

26 Drug Labeling 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 2015 EPSTEIN BECKER & GREEN, P.C. ALL RIGHTS RESERVED.. 26

28 Drug Apps in Enforcement Discretion 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 2015 EPSTEIN BECKER & GREEN, P.C. ALL RIGHTS RESERVED.. 28

29 Enforcement Discretion CDS per FDASIA Evidence-based clinician order sets tailored for a particular condition, disease, or clinician preference; Drug-drug interaction and drugallergy contraindication alerts to avert adverse drug events; Most drug dosing calculations; Drug formulary guidelines; Reminders for preventative care (e.g. mammography, colonoscopy, immunizations, etc.); 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 patientspecific information retrieved from a patient s EHR EPSTEIN BECKER & GREEN, P.C. ALL RIGHTS RESERVED.. 29

30 Regulated Pharma Apps 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 2015 EPSTEIN BECKER & GREEN, P.C. ALL RIGHTS RESERVED.. 30

31 21 CFR 3.2(e) 3 Types of Combination Products 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 2015 EPSTEIN BECKER & GREEN, P.C. ALL RIGHTS RESERVED.. 31

33 New FDA Regulatory System Requirements: Technology Contemplate the network No predefined clinical intended use Interoperability Standalone software that plays clinically significant roles Remote site of service Home use and mobile type considerations Human factors Telemedicine type issues The impersonal touch 2015 EPSTEIN BECKER & GREEN, P.C. ALL RIGHTS RESERVED.. 33

34 New FDA Regulatory System Requirements: Business Model Collaboration among IT technical experts, clinicians, medical device developers and scientists of many sorts. Virtual development processes Even shorter product lifecycles Modularization of software Easier entry for those not experienced in health 2015 EPSTEIN BECKER & GREEN, P.C. ALL RIGHTS RESERVED.. 34

35 Specific Needed Improvements Innovation Factor 1. Cost and timelines for developing products Needed Regulatory Change 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 2015 EPSTEIN BECKER & GREEN, P.C. ALL RIGHTS RESERVED.. 35

36 New Approach Innovation Factor 3. Components for unspecified systems Needed Regulatory Change Tool intended uses Accessory classifications 4. Release of beta software programs Clarification on how investigational device rules apply to regulated software 2015 EPSTEIN BECKER & GREEN, P.C. ALL RIGHTS RESERVED.. 36

37 New Approach Innovation Factor 5. Frequent incremental improvements to software Needed Regulatory Change Clear triggers for premarket requirements 6. Key role of standalone software Guidance on Premarket data requirements Quality system regulation Postmarket reporting obligations 2015 EPSTEIN BECKER & GREEN, P.C. ALL RIGHTS RESERVED.. 37

38 Legislation MEDTECH Act SOFTWARE Act Senate Carves out several categories of lowrisk technology that should not be regulated Administrative or operational support for a healthcare facility; certain EHRs; lab information systems; etc. CDS that is transparent House Approaches software categorization and regulation from a functional use approach (i.e. what is the software doing) New definitions: medical software and health software New regulatory requirements for medical software. Health software unregulated 2015 EPSTEIN BECKER & GREEN, P.C. ALL RIGHTS RESERVED.. 38