Transcript Regulatory Pathway for Platform Technologies

Regulatory Pathway for
Platform Technologies
Quynh Hoang
Neurotherapeutic and Neurodiagnostic Devices Branch
Division of Ophthalmic, Neurological and Ear, Nose and
Throat Devices
Office of Device Evaluation
Center for Devices and Radiological Health
ASENT February 24, 2011
Disclaimer
This presentation reflects the
views of the author and should not
be construed to represent FDA’s
views or policies.
Overview
• Regulatory definitions: drug, device, biological
product, combination product
• Medical Device Platform Technology Examples
• OCP and Lead Center
• Medical Device Classifications and
Corresponding Applications
• Medical Device Submissions for Platform
Technology Examples
• Recent Development in CDRH
Center for
Food Safety
& Applied
Nutrition
(CFSAN)
Center for
Tobacco
Products
(CTP)
Center for
Veterinary
Medicine
(CVM)
FDA
Center for
Biologics
Evaluation &
Research
(CBER)
National Center
for Toxicology
Research
(NCTR)
OCP
Center for
Devices &
Radiological
Health
(CDRH)
Center for Drug
Evaluation and
Research
(CDER)
Drug Definition
(A) articles recognized in the US Pharmacopoeia,
Homeopathic Pharmacopoeia, or National
Formulary; or
(B) articles intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease in
man or other animals; or
(C) articles (other than food) intended to affect the
structure or any function of the body of man or
other animals.
21 USC 201(g)
Device Definition
Instrument, apparatus, implement, machine, contrivance, implant,
in vitro reagent, or other similar or related article, including any
component, part, or accessory, which is (1) recognized in the official National Formulary, or the United States
Pharmacopoeia, or any supplement to them, or
(2) intended for use in the diagnosis of disease or other conditions, or
in the cure, mitigation, treatment, or prevention of disease, in man
or other animals, or
(3) intended to affect the structure or any function of the body of man
or other animals,
and which does not achieve its primary intended purposes
through chemical action within or on the body of man or
other animals and which is not dependent upon being
metabolized for the achievement of its primary intended
purposes.
21 USC 201(h)
Biological Product Definition
–
–
–
–
–
–
–
Virus
Therapeutic Serum
Toxin or Antitoxin
Vaccine
Blood, Blood Component or Derivative
Allergenic Product
Protein (except any chemically synthesized
polypeptide)
– Analogous Product (e.g., human tissues)
– Arsphenamine or its derivatives
applicable to the prevention, treatment, or cure of diseases or
injuries of man
42 USC 262 (as amended 2010)
Combination Product Definition
 Combination of
– Biological Product & Device
– Biological Product & Drug
– Device & Drug
– Biological Product & Device & Drug
– NOT of drug&drug, device&device or
biologic&biologic
 Combination from being:
– Physically or chemically combined
– Co-packaged in a kit
– Separate, cross-labeled products
21 CFR 3.2(e)
Medical Device Platform Technology
Examples
• New indication for a
marketed device
• New component for a
marketed device to
support new indication
• Combining a marketed
device with a marketed
drug and/or biological
product
Medical Device Platform Technology
Examples
• New indication for a
marketed device
• New component for a
marketed device to
support new indication
• Combining a marketed
device with a marketed
drug and/or biological
product
Device
Device
Combination
Product !
Office of Combination Product
(OCP)
OCP determines lead Center
OCP’s algorithm
1. Primary mode of action
2. If unable to determine most important
therapeutic action with reasonable
certainty, consider:
–
–
Consistency: is there an agency component that
regulates other combination products presenting
similar questions of S & E with regard to
combination product as a whole?
Safety and Effectiveness: which agency component
has the most expertise related to most significant
S&E questions presented by combination product?
Medical Device Platform Technology
Examples
• New indication for a
marketed device
• New component for a
marketed device to
support new indication
• Combining a marketed
device with a marketed
drug and/or biological
product
Device
Device
CDRH-Lead
Device Regulation is Risk-based
Medical Device Classes:
Class I
General Controls
Most exempt from
premarket submission
Class II
General Controls
Special Controls
Premarket Notification
[510(k)]
Class III
Premarket
Approval
Premarket Approval Application [PMA]
Additional Classification:
De Novo
Device
"types" that have never been
marketed in the U.S., but whose
safety profile and technology are
now reasonably well understood
Humanitarian
Device
Exemption
(HDE)
Devices for orphan diseases intended
to benefit patients in diagnosis and/or
treatment of disease or condition
affecting or manifested in fewer than
4,000 patients per year in the US.
Investigational Device Exemptions
(IDE) application
An FDA approved IDE allows a significant
risk investigational device to be used in a
clinical study in the U.S. in order to collect
safety and effectiveness data
21 CFR 812
Medical Device Platform Technology
Examples
• New indication for a
marketed device
• New component for a
marketed device to
support new
indication
• Combining a
marketed device with
a marketed drug
and/or biological
product
What was the
marketing
pathway for the
platform
technology?
Platform Technology was 510(k) “cleared”
or De Novo “classified”
• Change to Indication: Does the change to the
indication alter the intended
therapeutic/diagnostic/etc. effect (or impact
safety or effectiveness)?
• Change to Technology: Does the change raise
new types of safety or effectiveness questions?
No to both  510(k)
Yes to either  De Novo, PMA, or HUD/HDE
AND supporting clinical (IDE) data for a
significant risk device
Platform Technology was
PMA “approved”
• Original PMA
• Panel-Track PMA Supplement, or
• PMA Supplement
(with IDE data to support new indication or
claim)
Platform Technology was
HDE “approved”
Request a Humanitarian Use Device
(HUD) Designation from the Office of
Orphan Products Development for the
new device.
a. If HUD is granted, HDE (with clinical to
support new indication).
b. If HUD is not granted, 510(k) or PMA.
Marketing Applications
• 510(k) – substantial equivalence to a predicate
• De Novo
– After a not-substantially-equivalent 510(k)
determination
– Low risk, Available data and Special controls
• PMA – reasonable assurance of safety and
reasonable assurance of effectiveness
• HDE – reasonable assurance of safety and
probable benefit
Some Recent Developments
in CDRH
• CDRH Preliminary Internal Evaluations of the
510(k) review process
• CDRH Innovation Pathway
• Streamline the De Novo process
www.fda.gov (search highlighted terms)
FDA Contacts
• OCP: [email protected] or 301-796-8930
• Orphans Product: 301-796-8660
• Medical Device Pre-market Process-Programs
Operations Staff: [email protected]
or 301-796-6560
• Neuro Device Pre-market Questions:
[email protected] or 301-796-6610
CDRH Information Resources: search term
“CDRH Learn” or “Device Advice” from Google
or on www.fda.gov
Thank You!