FDA BRIEF: Week of July 29, 2016

fda guidances

RWE.JPG

SCOPE:

Real-World Data (RWD): Data collected from sources outside of traditional clinical
trials

Real-World Evidence (RWE): Evidence derived from aggregation and analysis of
RWD elements.

FDA’s National Evaluation System leverages RWD to identify safety problems, to better understand the benefit-risk profile, reduce the time and cost of evidence generation

RWE:

  • Of sufficient quality to provide confidence in analyses for regulatory decision making
  • May be used in total product life cycle e.g. generating clinical study hypotheses, historical control, concurrent control group, expand labeling, public health surveillance

RWD:

  • Relevance: Ddata adequately addresses applicable regulatory question/ requirement
  • Reliability: Data accrual, Data adequacy, Data assurance

Comment period : End October.

READ


UDI.JPG

SCOPE:

Defines expected content and forms of the Unique Device Identifier (UDI) to assist both labelers and FDA-accredited issuing agencies

UDI Rule:

  • Create a standardized identification system for medical devices in US
  • Adequately identify devices through distribution and use

UDI Forms:

  • Easily readable plain-text
  • AIDC

UDI Content, Data delimiters

Comment period: End September

READ


 

adaptive.JPG

SCOPE:
How to plan and implement adaptive designs for clinical studies when used in medical device development programs

Adaptive Designs:

  • prospectively planned modifications based on accumulating study data without undermining the study’s integrity and validity
  • efficient, saving time, money, and resources
  • can improve the chance of trial success by employing sample size reassessment
  • may facilitate transition from premarket to postmarket follow-up
  • can enhance patient protection
  • can include a plan to modify the patient population during the study
  • can improve decision-making at milestones
  • Limitations: more effort at the design stage, can introduce operational or statistical bias, may confound the interpretation,

Principles:

  • control of the chance of erroneous conclusions (positive and negative)
  • minimization of operational bias

Adaptations Using Unblinded Data:

  • Group Sequential Designs, Sample Size Reassessment, Bayesian Sample Size Adaptation,  Group Sequential Designs etc.

Special Considerations:

  • Not Preplanned chnages, Simulations, Safety Endpoints,  Open-Label Randomized Studies, Observational Comparative Studies, One-Arm Studies without a Control

Challenges:

  • Data Monitoring Committees,  Minimize Operational Bias, IRBs, Logisitcs

Regulatory Considerations:

  • FDA interactions, Sponsor Monitoring, Protect Study Blinding

READ


wellness.JPG

POLICY for low risk general wellness products

CDRH does not intend to examine

  • whether they are devices
  • whether they comply with the premarket review and post-market regulatory requirements for devices
  • whether they are implementing regulations : registration and listing, premarket notification, labeling, good manufacturing practice,  Medical Device Reporting

Must meet factors

  • intended for only general wellness use AND
  • present a low risk to the safety of users and other persons

Intended Use

  • Maintaining or encouraging a general state of health or a healthy activity
  • Relates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions

CATEGORIES

Sustaining or offering general improvement to functions with general health

  • weight management, physical fitness, relaxation or stress management, mental acuity, self-esteem, .sleep management, sexual function

Sustaining or offering general improvement to functions associated with a general state of health while making reference to diseases or conditions

  • may help to reduce the risk of certain chronic diseases or conditions
  • may help living well with certain chronic diseases or conditions

QUESTIONNAIRE to determine fit

READ


 

 

 

 

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s