FDA and telehealth

Digital Health – FDA

Dec 7, 2017 – The broad scope of digital health includes categories such as mobile health (mHealth), health information technology (IT), wearable devicestelehealth and telemedicine, and personalized medicine. Providers and other stakeholders are using digital health in their efforts to: Reduce inefficiencies,; Improve …

Mobile Medical Applications – FDA

Jump to Does the FDA regulate mobile devices and mobile app stores? – FDA’s mobile medical apps policy does not consider entities that exclusively distribute mobile apps, such as the owners and operators of the “iTunes App store” or the “Google Play store,” to be medical device manufacturers.FDA’s …

Press Announcements > FDA approves first telehealth option to …

Nov 17, 2017 – “Programming adjustments to a cochlear implant are performed at specialized cochlear implant centers or at clinics by audiologists with expertise in cochlear implants. Being able to have a qualified audiologist program the device via telemedicine from a remote location can greatly reduce the burden to …

FDA regulates telemedicine on smart phones : CAMLAW …

http://www.camlawblog.com › New Regulation

As one law firm explains in Is Your Smart Phone An FDA-Regulated Medical Device? – FDA Announces Plans To Regulate “Mobile Medical Applications:”. The FDA views handheld computers loaded with these apps to be medical “devices” subject to extensive FDA regulation. The FDA’s draft guidance sets out its current …

FDA clears telehealth option to remotely program cochlear implants …

Nov 27, 2017 – FDA regulations · Telehealth · Mobile technology. print reprint. The Food and Drug Administration has approved the first telehealth option to remotely program electronic hearing devicescalled cochlear implants, rather than having audiologists make programming adjustments to them at specialized centers …

Thirty-six connected health apps and devices the FDA cleared in 2016 …

Dec 30, 2016 – While connected blood glucose monitors and devices incorporating heart rate sensors dominate the list, we also saw more apps and software … Medtronic received FDA clearance for its AVIVO Mobile Patient Management System, which continuously measures, records and periodically transmits data for …

FDA Establishes New Digital Health Unit « Center for Telehealth and e …

ctel.org › Telehealth Buzz

May 12, 2017 – On the new unit’s agenda: topics like wireless medical devicesmobile apps,telemedicine, software as a medical device, and interoperability, among others. The overall focus will be on bringing “regulatory clarity” to the relatively new and continually evolving industry. In particular, theFDA is seeking to …

FDA OKs Telemedicine Platform for Programming Cochlear Implants

Nov 20, 2017 – The announcement continues a string of FDA approvals over the past month of innovative telemedicine and mHealth devices. This one is designed to help the 58,000 adults and 38,000 children who have received cochlear implants since 2012. The implant is designed to electrically stimulate the nerves …

Remote Patient Monitoring Technologies Addressed by FDA

Jul 31, 2015 – Among the many mobile apps and devices that the FDA does consider under the definition of a medical device but does not pose any serious danger to patients … Another remote patient monitoring solution that’s made an impact is Authentidate’s telemedicine service, which has helped monitor the health of …

Why Mobile Health Applications Require FDA Regulation

Aug 5, 2015 – August 05, 2015 – If a medical device like a pacemaker was to be installed through surgery and hadn’t been thoroughly vetted by the proper agency, what patient would ever allow their doctor to go through with the surgery? It’s likely no such patient exists and healthcare advocates expect all medical …

Medical Device Design Control Implementation Summary List

1.      Identify Total Design Control Requirement
Review of specific design control requirements, determine their source and identify implementation methods.

·         Design Control

·         US – Food Drug and Cosmetics Act & 21 CFR Part 820

·         EU – Medical Device Directive (MDD) & EN ISO 13485:2012

·         Canada – Canadian Medical Device Regulations (CMDR) & ISO 13485:2003

·         Conformity Assessment Paths

·         US – Premarket Submissions

·         EU – MDD Annex II Technical Files & Design Dossiers

·         Canada – Medical Device License

·         Identify Total Design Control Requirements

2.      Developing a Project Plan
Analysis of a small example project, identify stages and develop a Work Breakdown Structure (WBS) and a Gantt chart for the project.

·         Planning Stages

·         Interfaces

·         Project Management Techniques

·         Action List

·         Work Breakdown Structure (WBS)

·         Gantt Chart

·         Critical Path Method (CPM)

·         Program Evaluation and Review Technique (PERT)

·         Developing the Design History File (DHF)

3.      Developing and Resolving Input Requirements
Develop a set of design inputs for an example product and use the results to identify missing, incomplete or ambiguous requirements.

·         Requirements for the Procedure

·         Resolving design input issues (incomplete, ambiguous, or conflicting requirements)

·         Identifying the design input requirements

·         Performance

·         Functional

·         Safety

·         Regulatory

·         Market

·         Starting a trace matrix

·         Developing and Resolving Input Requirements

4.      Design Output Completeness
Review design outputs for an example product and identify essential requirements, acceptance criteria and gaps in the requirements.

·         Requirements for the Procedure

·         Total finished design output

·         The device

·         Packaging and labeling

·         Device Master Record (DMR)

·         Acceptance criteria

·         Essential product characteristics

·         Continuing the trace matrix

5.      Identifying and Resolving Problems
Design reviews systematically, and examine a design to evaluate its adequacy and capability with the intent to identify problems. Participants critique a design review to determine if it is sufficient.

·         Requirements for the Procedure

·         What needs to be covered

·         Who needs to attend

·         How to document results

·         Integrating risk management

·         Design Review at each Stage

·         Creating and Closing Action Items

·         Identifying and Resolving Problems

6.      Design Verification Methods
Examine paired design inputs and design outputs and determine the best tool for design verification. In some cases the analysis is extended to look specific aspects of the tools.

·         Requirements for the Procedure

·         Design Verification Tools

·         Failure Modes and Effects Analysis (FMEA)

·         Fault Tree Analysis (FTA)

·         Inspections and Tests

·         Document Review

·         Alternate Calculations

·         Similar Designs

·         The sample size question

·         Continuing the trace matrix

·         Exercise – Design Verification Methods

7.      Examining a Design Validation Plan
Critique a design validation that starts with user needs and intended uses. The plan uses production equivalents and simulated use conditions.

·         Requirements for the Procedure

·         Initial Products or Equivalents

·         Defined conditions or simulation

·         Software Validation

·         Risk Management (ISO 14971:2007)

·         Usability Engineering

·         Continuing the trace matrix

·         Examining a Design Validation Plan

8. Determining When a Process Must be Validated
Some production processes require process validation, while others do not. You’ll determine analyze processes transferred to production and document whether they require process validation.

·         Requirements for the Procedure

·         Process Controls, 820.70(a)

·         Purchasing Data, 820.50(b)

·         Process Validation, 820.75

·         Determining When a Process Must be Validated

9. Classify Changes as a Design Change or a Production Process Change.

QSIT informs the FDA Investigator that Production and Process Changes could be Design Changes. This exercise gives attendees an opportunity to classify changes and provides insight into the decisions to make in the QMS.

  • Requirements for the Procedure
  • Design change interrelationships — the five important considerations
  • When a production change is a design change
  • Does the design change create a new Device Identifier?
  • Does the design change require an updated 510(k)?
  • Does the design change impact the Risk Management File?
  • Is the design change an enhancement or a recall?
  • The design change flow chart shows the picture

Design change records

Classify changes as a design change or a production process change