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Courting the FDA: Initial Interactions Through Long-Term Partnerships

FDA Interaction Strategies: Product Classification Pathways

November 3, 2014

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D I S P U T E S & I N V E S T I G A T I O N S • E C O N O M I C S • F I N A N C I A L A D V I S O R Y • M A N A G E M E N T C O N S U L T I N G

Regulatory Product

Classification

Drugs, Devices, Biologics and Combination

Products

Presenters

» Sharon Kvistad, Associate Director

› 30+ years as a regulatory professional

› Career focused in medical devices

› Large company, venture company and consulting experience

› Device development, clinical trials, manufacturing transfers, product recalls,

strategic planning

» Melanie Drayton, Managing Consultant

› 10+ years as a regulatory professional

› Former FDA Investigator – Office of Regulatory Affairs

› Former FDA Project Manager – Office of Biological Research and Evaluation

› Specific expertise in GMP inspections and complaints

Agenda

» Focus will be on U.S. - Devices, combination products and biologics

» What is “Classification”?

» How is classification determined?

» Factors influencing classification

› Indications

› Component delivering primary mode of action

What Is Classification?

» Classification is a general term used to categorize the amount of risk imposed by a

device

» In general, the higher the product risk, the more stringent the classification will be

e.g., Class I has less risk than Class III

» Combination Products (i.e. drug + device) will have a classification that is associated

with the device portion of the product

» Drugs and Biologics are not classified by risk but are differentiated by molecule size

Classification Types

» Medical Devices

› 3Classifications

‒ Class I, Class II or Class III

‒ Different classifications have different requirements for market entry

» Combination Products

› FDA reviewing division will be determined by the component of the product that

has the primary mode of action (PMOA):

‒ If a drug – CDER will lead review

‒ If a biologic – CBER will lead review

‒ If a device – CDRH will lead review

‒ No matter which branch of FDA leads the review, all combination products will

have a classification applied to the device portion of the product

Devices Overview

» Devices defined in Section 201(h) of the Federal Food, Drug and

Cosmetic (FD&C) Act

» Three classifications for devices: › Class I devices are subject to the least regulatory control; present minimal potential for

harm to the user; and are often simple in design compared with Class II and Class III

devices.

› Class II devices are those which require documentation to assure safety and

effectiveness. The documentation to be submitted to FDA is in the form of a Premarket

Notification, referred to as a 510(k).

› Class III devices are subject to the most stringent regulatory measures and are those for

which insufficient information exists to assure safety and effectiveness. These devices are

usually those that support or sustain human life, are of substantial importance in

preventing impairment of human health or which present a potential, unreasonable risk of

illness or injury. The documentation to be submitted to FDA is in the form of a Premarket

Application, referred to as a PMA.

Determining Device Classification

WHERE DO I START????

Factors in Determining Device Classification

» Predicate Device

» Safety and Effectiveness

› Established or not

» Indication for Use

‒ Where used in the body

‒ Disease or condition

Options for Obtaining Classification Information

» 513(g)

› Regulatory filing with FDA making the determination of classification

› 513(g) determination is final

› Device reviewers not involved in 513(g) review

» Pre-Submission for either 510(k) or PMA

› Sponsor must proffer device classification

› FDA will react but may not be comprehensive in response

› Allows more interaction with FDA review staff than 513(g)

» Request for Designation (Combo Products)

› FDA Office of Combo. Products will determine lead review based on product’s

primary mode of action (PMOA)

Determining Device Classification – con’t

» Is there anything on the market like your device?

› Technical attributes

› Labeling

› Method of action

» What if your device = an existing device???

› Generally adopt the same classification

» What if your device an existing device?

› Does not automatically mean different classification

≠

Determining Device Classification - Indications

» How important are the indications for your device?

» Changing classification examples

› OTC to Class II

› Class II to Class III

Combination Products Overview

Combination Products

» Any combination of a drug, device, and/or biologic

» Defined in regulation 21 CFR 3.2(e)

» Can be single-entity, co-packaged, or cross-labeled

Examples of Combination Products

» Single-entity: Asthma inhaler, drug-eluting stent, drug autoinjectors

» Co-packaged: Bone graft kit consisting of recombinant human bone protein and collagen sponge

» Cross-labeled: Skin cancer treatment consisting of drug that is photo-activated by separate light

source; Companion Diagnostics are also considered cross-labeled combination products

Unique Challenges of Combination Products

Regulatory

» Drug/device/biologic constituent parts have different regulatory pathways/strategies

» FDA’s Combination Product Final Rule lays out specific Quality System regulations

› Require a “hybrid” quality system supporting both drug/biologic and device elements

› Implications for both pharmaceutical, biotech and device companies

Development and Commercialization

» Drug/biologic/device constituent parts have different development and commercialization

processes/timelines

» Device/drug/biologic interaction/in-device stability

» PK/PD bridging studies

» Ease of use, human factors, usability studies

Postmarket

» Complaint handling

» Reporting

Biologics Overview

» Biologics defined in PHS Act section 351› Virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component, or derivative,

allergenic product, or analogous product…

› Applicable to prevention, treatment, or cure of a disease or condition of human beings

» CBER Product Classifications› Single Entity Product

‒ Products that contain a single type of regulated article (e.g., a singe biologic or mixture

of biologics)

› Combination Product

‒ A product comprised of two or more regulated products that are physically, chemically

or otherwise combined or mixed

› Human Tissue Product

Biologics – Combination Product

» Combination Product

› Center assignment based upon primary mode of action

› May require 1 application or 2 applications

› Flexibility in terms of regulatory path selection (Centers usually decide)

THANK YOU!

Presenter Contact Information:

Sharon [email protected]

Melanie [email protected]

mailto:[email protected]


Questions?

Next Webinars in Series

• Dec. 9 – FDA Interaction Strategies: Pre-Market

Skills

• Jun. 13 – FDA Interaction Strategies: Post-Market

Skills

Register online: http://www.medtech.org/events

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time!

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