BME 512 - FDA Overview

16 Device Classification Panels

- anesthesiology - cardiovascular - ENT - clinical chemistry - dental - hematology - immunology - gastroenterology - OB/Gyn - general/plastic surgery - radiology - physical medicine - hospital/personal use - neurology - ophthalmic - orthopedic

Medical Device Amendments Act

- expanded definition of "devices" - gave more detail and systematic approach to classification of devices - Risk-based approach : different levels of oversight depending on what class of product the device is (1-3). The higher the class, the more requirements

What does the FDA regulate?

- foods - dietary supplements - human drugs - vaccines, blood products and other biologics - medical devices - electronic products - cosmetics - veterinary products - tobacco products

What does FDA require of medical device companies?

- premarket notifications 510(k)s (class 2) - premarket approvals PMAs (class 3) - quality system regulations - establishment registration under correct label - device listing

History of FDA regulations

1906: Pure Food and Drugs Act 1937: untested medicine killed many patients (children) 1938: Food, Drug and Cosmetic Act 1976: Medical Device Amendments 1978: Good Manufacturing Practiced (GMP or cGMP) 1997: Food and Drug Administration Modernization Act (FDAMA) and Quality System Regulation (QSR) 2002: Medical Device User Fee and Modernization Act (MDUFMA) 2013: Unique Device Identifier Amendments (UDI)

What is a medical device?

An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent which is recognized in the official National Formulary or US Pharmacopoeia - intended for use in the diagnosis of disease or in the cure, mitigations, treatment, or prevention of disease or condition

How does FDA regulate

Develops regulations based on the laws set forth in the Federal Food, Drug and Cosmetic Act (FD&C Act)

Are apps regulated by FDA?

FDA published a guidance in 2013 stating that they intended to regulate apps

How is the FDA organized?

It is an agency within the US Department of Health and Human Services. Consists of the Office of the Commissioner, and 4 directorates overseeing: - medical products and tobacco - foods - Global Regulatory Operations and Policy - Operations

What is a 510(k)

Marketing application submitted for FDA - demonstrated substantial equivalence - clearance letter - Class 1: general controls only (usually exempt from 510(k)) - Class 2: 510(k) and general controls - 90 day review time (traditional)

What is a PMA

Marketing application submitted to FDA - contains sufficient valid scientific evidence to assure that the decie is safe and effective for its intended use - approval letter - Class 3: PMA and general controls - 180+ day review time

Which administration controls stuff in US vs globally?

US: FDA - Food and Drug Administration Global: OUS - Global Regulatory Agencies

Overall definition of a medical device

intended to affect the structure or any function of the body - does not achieve any of its primary intended purposes through chemical action within or on the body - not dependent upon being metabolized for the achievement of any of its primary intended purposes

What is the FDA responsible for?

protecting the public health by assuring that - foods are, safe, wholesome, sanitary, and properly labeled - human and veterinary drugs, vaccines and other biological products are safe and effective - medical devices intended for use are safe and effective