Transcript Overview of FDA Device Regulations

Overview of FDA
Device Regulations
Bob Assenzo
Critical Path Institute
[email protected]
1
Overview of FDA Device
Regulations - Outline





Introduction
Establishment Registration – 21 CFR 807
Medical Device Listing – 21 CFR 805
Premarket Notification 510(k) – 21 CFR
807 Subpart E
Premarket Approval (PMA) – 21 CFR 814
2
Overview of FDA Device
Regulations – Outline (cont.)




Investigational Device Exemption (IDE) –
21 CFR 812
Quality System Regulation (QS)/Good
Manufacturing Practices (GMP) – 21 CFR
820
Labeling – 21 CFR 801
Medical Device Reporting – 21 CFR 803
3
Introduction to Device Regulations


FDA’s Center for Devices & Radiological Health
(CDRH) is responsible for regulating firms that
manufacture, repackage, relabel, and/or import
medical devices sold in the US.
Additionally, CDRH regulates radiation-emitting
electronic products (medical & non-medical)
such as lasers, x-ray systems, ultrasound
equipment, microwave ovens & color TVs
4
Introduction to Device Regulations
Classifications


Medical devices are classified into Class I,
II, and III. Regulatory control increases
from Class I to III.
The device classification defines the
regulatory requirements for a general
device type.
5
Introduction to Device Regulations
Classifications (cont.)
Most Class I devices are exempt from
Premarket Notification 510(k)
 Most Class II devices require Premarket
Notification 510(k)
 Most Class III devices require Premarket
Approval
 For classification determination see:
www.fda.gov/cdrh/devadvice/313.html

6
Device Classification Panels




Most medical devices can be found in 21 CFR
862 – 893
FDA has classified and described over 1,700
distinct types and organized them into 16
medical specialty panels, e.g. 870 is
cardiovascular; 886 is ophthalmic
The CFR gives a general description, use, class,
and info about marketing requirements
www.fda.gov/cdrh/devadvice/3131.html
7
Introduction to Device Regulations
Basic Requirements







Establishment registration
Medical Device Listing
Premarket Notification 510(k), unless exempt, or
Premarket Approval (PMA)
Investigational Device Exemption (IDE) for
clinical studies
Quality System (QS) regulation
Labeling requirements
Medical Device Reporting (MDR)
8
Establishment Registration –
21 CFR Part 807





Manufacturers, domestic & foreign, and initial
distributors (importers) of medical devices must register
their establishments with the FDA.
All establishment registrations must be submitted
electronically, unless FDA grants a waiver
All registration information must be verified annually
(Oct 1-Dec 31)
Foreign manufacturers also must designate a US agent
Most establishments are required to pay an
establishment registration fee
9
Medical Device Listing –
21 CFR Part 807









Manufacturers must list their devices with the FDA.
Establishments required to list:
Manufacturers
Contract manufacturers that commercially distribute the
device
Repackagers and relabelers
Specification developers
Reprocessors single-use devices
Remanufacturer
Manufacturers of accessories and components sold
directly to the end user
US manufacturers of “export only” devices
10
Premarket Notification 510(k) –
21 CFR Part 807 Subpart E



If device requires the submission of a Premarket
Notification 510(k), it cannot be commercially
distributed until an authorizing letter of
substantial equivalence from FDA is received
A 510(k) must demonstrate that the device is
substantially equivalent to one legally in
commercial distribution in the US: (1) before
May 28, 1976, or (2) to a device that has been
determined by FDA to be substantially
equivalent
www.fda.gov/cdrh/devadvice/314.html
11
Premarket Notification 510(k) –
21 CFR Part 807 Subpart E (cont)



The Medical Device User Fee and
Modernization Act of 2002 authorizes FDA
to charge a fee for medical device
Premarket Notification 510(k) reviews.
Most Class I and some Class II devices are
exempt from the Premarket Notification
510(k) submission. See
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm
12
Premarket Notification 510(k) –
21 CFR Part 807 Subpart E (cont)




Review by Accredited Persons:
FDA has accredited 12 organizations to conduct
a primary review of 670 types of devices.
FDA must issue a final determination within 30
days after receiving a recommendation from an
Accredited Person
Accredited Person is exempt from any FDA fee;
the third party may charge a fee for its review
13
Premarket Approval (PMA) –
21 CFR Part 814



Products requiring PMAs are Class III devices
that are high risk devices that pose a significant
risk of illness or injury, or devices found not
substantially equivalent to Class I & II predicate
through the 510(k) process (Fee required)
The PMA process is more involved and includes
the submission of clinical data to support claims
made for the device
See www.fda.gov/cdrh/devadvice/pma/
14
Investigational Device Exemption
(IDE) – 21 CFR Part 812




An IDE allows the investigational device to be
used in a clinical study to collect safety &
effectiveness data required to support a PMA
application or a Premarket Notification 510(k)
submission to FDA.
Clinical studies of devices with significant risk
must be approved by FDA and an IRB before
study can begin
Studies of devices of nonsignificant risk must be
approved by the IRB before study can begin
See www.fda.gov/cdrh/devadvice/ide/index.shtml
15
Quality System Regulation (QS)/Good
Manufacturing Practices (GMP) – 21 CFR
Part 820



The quality system regulation includes
requirements related to the methods used in
and the facilities and controls used for:
designing, purchasing, manufacturing,
packaging, labeling, storing, installing and
servicing of medical devices
Manufacturing facilities undergo FDA inspections
to assure compliance with the QS requirements
See www.fda.gov/cdrh/devadvice/32.html
16
Labeling – 21 CFR Part 801


Labeling includes labels on the device as
well as descriptive and informational
literature that accompanies the device
www.fda.gov/cdrh/devadvice/33.html
17
Medical Device Reporting –
21 CFR Part 803




Incidents in which a device may have
caused or contributed to a death or
serious injury must be reported to the FDA
Certain malfunctions also must be
reported
The MDR regulation is a mechanism for
identifying and monitoring significant Aes
www.fda.gov/cdrh/devadvice/351.html
18
Guidance Documents





Good Guidance Practice (GGP) relate to:
The processing, content, and evaluation of
regulatory submissions
The design, production, manufacturing,
and testing of regulated products
The inspection and enforcement
procedures
www.fda.gov/cdrh/guidance-about.html
19