FDA Milestones

Easing regulatory compliance

Laurel Thoennes @ Quality Digest

February 19, 2019

Compliance to U.S. Food and Drug Administration (FDA) regulations has come a long way in the past 30 years. Here are the main changes. Have they affected your business?

1988: Food and Drug Administration Act
Officially establishes the FDA as an agency of the Department of Health and Human Services and broadly spells out the responsibilities for research, enforcement, education, and information

1988: The Prescription Drug Marketing Act
Requires drug wholesalers to be licensed by the states; restricts reimportation from other countries; and bans sale, trade, or purchase of drug samples, and traffic or counterfeiting of redeemable drug coupons

1990: Safe Medical Devices Act (SMDA)
Provides the FDA with two additional post-marketing activities: post-market surveillance for the monitoring of products after their clearance to market; and device tracking for maintaining traceability of certain devices to the user level

1991: Manufacturer and User Facility Device Experience (MAUDE)
The FDA’s reporting system for post-market surveillance is made into a searchable online database that includes all reported events in which medical devices may have malfunctioned or caused a death or serious injury.

1992: The Prescription Drug User Fee Act (PDUFA)
Authorizes the FDA to collect fees from companies that produce certain human drug and biological products. PDUFA was passed to shorten the length of time from a manufacturer’s submission of a New Drug Application or a Biologics License Application to an FDA decision approval or licensure.

1993: MedWatch: The FDA Safety Information and Adverse Event Reporting Program
For “voluntarily reporting a serious adverse event, product quality problem, product use error, or therapeutic inequivalence/failure that may be associated with the use of an FDA-regulated drug, biologic, medical device, dietary supplement or cosmetic.” MedWatch Learn teaches students, health professionals, and consumers how to complete the forms necessary to report problems to the FDA.

1996: Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation
For 21 CFR Parts 808, 812, and 820. Revises CGMP requirements for medical devices and incorporates them into a quality system regulation with requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of medical devices intended for human use.

1996: Medical Device Reporting (MDR)
Provides a mechanism for the FDA, device manufacturers, and user facilities to identify and monitor significant adverse events involving medical devices. Goals are to detect and correct problems in a timely manner.

1997: Food and Drug Administration Modernization Act (FDAMA)
Improving regulation of drugs, improving regulation of devices, improving regulation of food

2002: Pharmaceutical Quality for the 21st Century—A Risk-Based Approach
Modernizes the FDA’s regulation of pharmaceutical quality for veterinary and human drugs and select human biological products such as vaccines. Current good manufacturing practices are important for improving overall product quality.

2002: Medical Device User Fee and Modernization Act (MDUFMA)
Amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) to provide FDA new responsibilities, resources, and challenges

2004: Critical Path Initiative
The FDA’s effort to stimulate and facilitate a national effort to modernize the sciences through which FDA-regulated products are developed, evaluated, and manufactured

2006: Quality Systems Approach to Pharmaceutical CGMP Regulations
Helps manufacturers implementing modern quality systems and risk management approaches to meet the requirements of the agency’s current good manufacturing practice (CGMP) regulations (21 CFR parts 210 and 211)

2007: PDUFA (IV)/FDAAA Amended Federal Food, Drug, and Cosmetic Act (FDCA)
Provides the FDA the legal authority to require risk evaluation and mitigation strategies (REMS) for applicable drugs

2007: Food and Drug Administration Amendments Act (FDAAA)
Prescription Drug User Fee Act (PDUFA) and Medical Device User Fee and Modernization Act (MDUFMA) are reauthorized and expanded to ensure the FDA has additional resources to conduct reviews necessary to new drugs and devices.

2008: Sentinel Initiative
The FDA Center for Drug Evaluation and Research’s (CDER) active surveillance program is used to efficiently monitor the safety of medical products (including drugs, vaccines, biologics, and medical devices) on a massive scale.

2009: FDA Transparency Initiative
A program performance management system that tracks the agency’s progress on activities in more than 100 program areas

2010: FDA Transparency Results Accountability Credibility Knowledge Sharing (TRACK)
The FDA’s agencywide performance management system that monitors FDA programs through key performance measures and projects

2011: Case for Quality
Elevates the focus of all medical device stakeholders from baseline regulatory compliance to sustained, predictive practices that advance medical device quality and safety to achieve better patient outcomes

2012: Launch of FDA Adverse Event Reporting System (FAERS)
FAERS is a database that contains adverse event reports, medication error reports, and product quality complaints resulting in adverse events that were submitted to the FDA. Database supports the FDA’s post-marketing safety surveillance program for drug and therapeutic biologic products. See FAERS Public Dashboard to search for human adverse events reported by the pharmaceutical industry, healthcare providers, and consumers.

2012: Food and Drug Administration Safety and Innovation Act (FDASIA)
Expands FDA authorities to collect user fees from industry to fund reviews of innovator drugs, medical devices, generic drugs, and biosimilar biological products; promotes innovation to speed patient access to safe and effective products; increases stakeholder involvement in FDA processes, and enhances the safety of the drug supply chain

2013: Drug Quality and Security Act
Grants the FDA more authority to regulate and monitor the manufacturing of compounded drugs. Title II of the bill—the Drug Supply Chain Security Act—outlines steps for an electronic and interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.

2013: Mobile Medical Applications
Guidance to inform manufacturers, distributors, and other entities about how the FDA intends to apply its regulatory authorities to select software applications intended for use on mobile platforms (mobile applications or “mobile apps”)

2013: Global Unique Device Identification Database (GUDID)
A system to adequately identify devices through distribution and use. The unique device identification system will be phased in over several years.

2014: Electronic Medical Device Reporting (eMDR)
Requires manufacturers and importers to submit medical device reports (MDRs) to the FDA in an electronic format that the FDA can process, review, and archive. See Electronic Submissions Gateway.

2016: 21st Century Cures Act
Mandates the creation or revision of policies and processes intended to speed patient access to new medical devices

2017: Current Good Manufacturing Practice (cGMP) Requirements for Combination Products
Clarification of the Jan. 22, 2013, Final Rule on current combination product cGMPs. Any entity engaged in the production of combination products requires a quality management system (QMS) with comprehensive workflow management and document management capabilities for regulatory reporting in the event an FDA inspector visits and requests it as part of its observations during or after a site visit.

2017: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
How the FDA evaluates real-world data (the raw information about patient health status and/or delivery of healthcare collected from a variety of sources) and determines whether they are of sufficient quality for generating the types of real-world evidence that can be used in the FDA

2017: Software as a Medical Device (SaMD): Clinical Evaluation
“Software as a Medical Device” (SaMD) is defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.

2018: Safety and Performance Based Pathway
For 510(k) clearance. Allows manufacturers to use objective performance criteria established or recognized by the FDA to facilitate demonstration of substantial equivalence of their new products to legally marketed devices

2018: Information Exchange and Data Transformation (INFORMED) Initiative
Creates a big data environment to enable data explorations that can yield groundbreaking scientific and regulatory insights

2018: Medical Device Safety Action Plan
• Establish unique device identification system to identify medical devices through their distribution and use
• National Evaluation System for health Technology (NEST): Intended, in part, to be an active surveillance and evaluation system that complements the passive surveillance approaches currently in use
Modernizing FDA’s 510(k) program for premarket review of medical devices: Where appropriate, new medical devices coming to market under the 510(k) pathway should either account for advances in technology that can improve the safety or performance of these products, or demonstrate that they meet more modern safety and performance criteria.

Fall 2019: Harmonizing and Modernizing Regulation of Medical Device Quality Systems
Revisions will supplant the existing requirements with the specifications of an international consensus standard for medical device manufacture, ISO 13485:2016. Revisions are intended to reduce compliance and recordkeeping burdens on device manufacturers.

September 2020: Accreditation Scheme for Conformity Assessment (ASCA)
To enhance the medical device review process by reducing premarket questions in areas where current conformity activities result in inconsistent testing practices, conformance declarations, and regulatory review. The ASCA pilot program will launch as soon as possible and before Sept. 30, 2020.

About The Author

Laurel Thoennes @ Quality Digest’s picture

Laurel Thoennes @ Quality Digest

Laurel Thoennes is an editor at Quality Digest. She has worked in the media industry for 31 years at newspapers, magazines, and UC Davis—the past 23 years with Quality Digest.