The voluntary eSTAR (electronic Submission Template And Resource) is a fillable portable document format (PDF) document that seeks to make 510(k) and De Novo submissions quicker and easier due to its automation from its form construction and autofill capability
With the growth of computational capabilities, artificial intelligence (AI) and machine learning (ML) have become a beacon of interest from both the product development side and the regulatory side. Implementation of AI and ML methodologies into the day-to-day life of our society is a real and ever-growing adaptive process. The FDA has just released a document that facilitates discussion and brings about important ideas for its place in society and how it will be regulated . In 2021, over one hundred submissions to the FDA included some usage of AI/ML .
In 1906 the Pure Food and Drug Act (Dr. Wiley’s Law) was passed by the Congress and signed by President Theodore Roosevelt, bringing the governing body of the Food and Drug Administration (FDA) into existence. The first commissioner of the FDA was Dr. Harvey Washington Wiley, who previously was the chief chemist of the USDA Bureau of Chemistry . Previously to the FDA, the Bureau of Chemistry regulated food safety. The implementation of the FDA was the first comprehensive consumer protection agency in the federal government . The first glimpse into what would eventually become the FDA, was the U.S Pharmacopeia which was started back in 1820 and sought to standardize drugs .
The international Banff classification is commonly used by physicians to analyze biopsies of the transplanted kidneys. This is used to diagnose the rejection of kidney transplants; however, this classification has become more complex which leads to variability in its application and misclassification. These misclassifications can lead to physicians failing to modify or incorrectly modify the treatment regimen to protect the patient.
Under FDA compliance, to bring a medical device to market, there are a multitude of regulations that need to be accounted for and followed. Many of these regulations fall under the Code of Federal Regulations (CFR), however, others are known as recognized consensus standards. These recognized consensus standards are adopted from the International Organization for Standards (ISO), Clinical & Laboratory Standards Institute (CLSI), American Society for Testing and Materials (ASTM), American National Standards Institute (ANSI), Association for the Advancement of Medical Instruments (AAMI), International Electrotechnical Commission (IEC), or other Standards Development Organizations (SDOs). These standards can either be voluntary or required via being ‘incorporated by reference’ into the regulation (CFR) .
Since the introduction of the term by Seth Frank back in 2000 , the idea of digital health has revolutionized many of our current healthcare and global health practices. With roughly 6 billion USD in funding in 2017, the development of digital health technologies and the systems in which they run were appearing at an extremely rapid rate [1,2]. Currently, the FDA categorizes digital health into mobile health, health information technology, wearable devices, telehealth and telemedicine, and personalized medicine [2,3].
Under FDA regulations device labelers must generate a unique device identifier (UDI) for each of their products that are headed to market. This identifier will then be stored within the global unique identification database (GUDID) allowing for eased product lookup. However, certain class I and unclassified devices are not required to be a part of the GUDID. The UDI allows for eased tracking of devices that are in distribution from either human or machine-readable identifiers.
Classification of certain medical devices may be predisposed to ambiguities related to which classification type (I, II, or III) they belong too. The three FDA classification types for medical devices are: I - general control, II - special controls including general controls or III - premarket approval including general controls . Proper definition of the classification in which the medical device belongs to is necessary for FDA compliance. In the case that the medical device has an indeterminate classification, a 513(g) can be exercised to request FDA guidance for its proper classification.
Complaint management systems are a necessary part of a Quality Management System. Complaint management is defined as any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution. As outlined in 21 CFR 820.198, each manufacturer maintains complaint files and has a process for receiving, reviewing, and evaluating complaints. This must be done in a timely manner and be done by a formal complaint handling unit.
The FDA divides Life science products up into different categories with their associated centers. These centers, for medical products, are Drugs, Devices, and Biologics. If a product applies to more than one of these centers, it is sent to the office of combination products which serves as the focal point for medical product classification and assignment issues.