Lecture 1 Flashcards
(11 cards)
1
Q
What is regulation?
A
- legal obligation
- an expense that contributes to the cost of doing business, but MUST be considered from the very beginning
2
Q
What is the FDA’s main purpose?
A
- protection of public health
- assure the safety and effectiveness of the products under its supervision
- implements regulatory controls to stringently monitor medical device development
3
Q
What are the core principles/concepts of regulations?
A
- Safety: product should ideally do no harm; manufacturers must demonstrate safety
- Efficacy: product must do some good
- Purpose: measure of effectiveness, utilize ‘intended use’ statements
- Risk/benefit: weigh the risks and benefits of the product, include a risk management process
- Quality: should be reliable and consistent, meets agreed specifications/standards
4
Q
Regulatory Bodies in Ireland
A
- COMPETENT AUTHORITY (CA): Health Products Regulatory Authority (HPRA)
- NOTIFIED BODY (NB): National Standards Association of Ireland (NSAI)
- also relevant: FDA and World Health Organization
5
Q
Medical Device Amendments Act (MDAA)
A
- 1976: after which point devices began to be properly regulated
- part of this enaction was due to the Dalkon Shield intrauterine device
- IUD that actually had a 5.5 percent failure rate, from increased pregnancy complications, infections, to death
6
Q
Aspects of the FDA Definition of a Medical Device
A
- intended for use in the diagnosis of disease OR
- for use in the cure, mitigation, treatment, or prevention of disease
- intended to affect the structure or any function of the body
- that which does not achieve its primary intended purposes through chemical action
- not a drug or biologic? it is a device
7
Q
FDA Classification of Medical Devices
A
- Class I: Low risk, 55% of devices
- Class II: Medium risk, usually 510k, 40% of devices
- Class III: High risk, about 5% of devices
8
Q
Class I
A
- devices presenting low risk of harm, are subject to general controls (sufficient to protect user)
- most are exempt from regulatory process
- examples: elastic bandages, tongue depressors, gloves, slings
9
Q
Class II
A
- more complicated, require special controls for labelling, guidance, design, monitoring, etc.
- most require Premarket Notification, 510(k)
- examples: catheters, blood pressure cuffs, syringes, blood transfusion kits, contact lenses, absorbed sutures
10
Q
Class III
A
- devices that usually sustain or support life, are implanted, or present potential unreasonable risk of illness/injury
- toughest regulatory controls, most require Premarket Approval (PMA)
- examples: pacemakers, cochlear and breast implants, endovascular stents, transcatheter heart valves
11
Q
Femoral Catheter Class
A
Class II
