Lecture 2

Question 1

Exemptions to regulatory pathways

Answer 1

• about 3/4 of class I devices are exempt… aka they do not require FDA clearance to be marketed
• less than 10% of class II devices are exempt (must present minor safety risk)

Question 2

Device Exemption

Answer 2

• even if determined to be exempt, the device is subject to general controls, which are applied to all three regulatory pathways
• limited number of class I exempt devices are also exempt from QSR requirements

Question 3

Quality Systems Regulation (QSR)

Answer 3

• set of guidelines for safe design and manufacturing
• quality system (QS) must be developed that matches the device’s risk, complexity, extent of activities, and size of manufacturer
• harmonized with ISO 13485: Medical Devices

Question 4

Overview of QSR for Medical Devices

Answer 4

1) establish Quality System
2) establish a quality policy and structure
3) establish a quality plan and system procedures
4) conduct audits and control the design process
5) define and control manufacturing processes
6) manage data and undertake actions

Question 5

510(k) Basics

Answer 5

• new device is automatically in Class III, and either needs premarket approval or reclassification before marketing
• unless it can be proved “substantially equivalent” to another commercially existing Class II
• all 510(k)s based on this concept, also called a predicate (they provide a comparison between new and existing device)
• in some cases, SE can be claimed to more than one predicate
• costs from $2,000 to $12,000 in addition to FDA $5,000 fee

Question 6

Substantial Equivalence (SE)

Answer 6

• new device is as safe and effective as the predicate
• SE requires for the device to have same intended use and technological characteristics, OR different characteristics that do not raise new questions of safety/effectiveness
• in this case, sponsor must demonstrate that the device is as safe and effective

Question 7

Bone Fixation Plate

Answer 7

• similar to a Class II device
• will require a 510(k) most likely

Question 8

More on SE

Answer 8

• don’t have to be identical devices
• established with respect to design, materials, performance, effectiveness, standards, labelling, etc.

Question 9

510(k) Submission Sections

Answer 9

• indications for use
• Comparing Your Product vs. Predicate(s)
• Ensuring Patient Safety
• Performance Testing: bench, animal, and clinical

Question 10

Premarket Approval (PMA)

Answer 10

• FDA process of scientific/regulatory review to evaluate the safety and effectiveness of Class III medical devices
• most stringent
• applies to devices that involve significant risk, do not have predicates, or are similar to other class III devices

Question 11

PMA requirements

Answer 11

• Non-clinical laboratory studies: microbiology, toxicology, immunology, shelf life, more laboratory or animal tests (these studies must be conducted in compliance with 21 CFR Part 58)
• Clinical investigations section: study protocols, safety data, adverse reactions, device failures, patient information, etc.
• study may be conducted under an Investigational Device Exemption (IDE)

Question 12

Investigational Device Exemption (IDE)

Answer 12

• needed to perform clinical study, in which you collect safety and effectiveness data (prior to market release)
• needs to be approved by institutional review board, and sometimes FDA
• needs informed patient consent, proper labelling and monitoring, and required reports

Question 13

PMA Costs

Answer 13

• around $85k for smaller business, and $340k for larger businesses in addition to FDA flat rate
• costs manufacturers on average $94 million to bring device onto the market through PMA, and 276 days
• 510(k) usually only $31 million, and around 133 days
• on average takes 2-7 years to bring medical device onto US market
• 95%-98% of devices come through 510(k) or premarket notification, and only 5% through PMA