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

This presentation reflects the views of the author and should not be construed to represent FDA’s views or policies.

• 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)
Center for
Biologics
Evaluation &
Research
(CBER)
Center for
Devices &
Radiological
Health
(CDRH)
FDA
OCP
Center for Drug
Evaluation and
Research
(CDER)
National Center for Toxicology
Research
(NCTR)

(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)

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)

– 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 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)

• 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

• New indication for a marketed device Device
• New component for a marketed device to support new indication
• Combining a marketed device with a marketed drug and/or biological product
Device
Combination
Product !

OCP determines lead Center

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?

• New indication for a marketed device Device
• New component for a marketed device to support new indication
• Combining a marketed device with a marketed drug and/or biological product
Device
CDRH-Lead

Medical Device Classes: Additional Classification:
De Novo
Class I
General Controls
Most exempt from premarket submission
Device
"types" that have never been marketed in the U.S., but whose safety profile and technology are now reasonably well understood
Class II
General Controls
Special Controls
Premarket Notification
[510(k)]
Class III
Premarket
Approval
Premarket Approval Application [PMA]
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.

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

• New indication for a marketed device
• New component for a marketed device to support new indication
What was the marketing pathway for the platform technology?
• Combining a marketed device with a marketed drug and/or biological product

• 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

• Original PMA
• Panel-Track PMA Supplement, or
• PMA Supplement
(with IDE data to support new indication or claim)

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.

• 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

• CDRH Preliminary Internal Evaluations of the
510(k) review process
• CDRH Innovation Pathway
• Streamline the De Novo process www.fda.gov
(search highlighted terms)

• OCP: combination@fda.gov or 301-796-8930
• Orphans Product : 301-796-8660
• Medical Device Pre-market Process-Programs
Operations Staff: Robert.Gatling@fda.hhs.gov or 301-796-6560
• Neuro Device Pre-market Questions:
Quynh.Hoang@fda.hhs.gov or 301-796-6610
CDRH Information Resources : search term
“CDRH Learn” or “Device Advice” from Google or on www.fda.gov