Medical Devices Archives - EMMA International

The History of The Food and Drug Administration (FDA)

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 [1]. 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 [1]. 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 [2].

Recognized Consensus Standards

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) [1].

Enhancing Marketing With EMMA’s Label Review

Pharmaceutical and medical device industries face numerous challenges when it comes to marketing their products. One...

The 513(g) Process

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 [1]. 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

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.

Bringing a Medical Device to Market

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.

Supplier Controls

How does a medical device manufacturer make sure that they prevent garbage from coming into their factory, and therefore lessen the ways that garbage can go out? Supplier controls are a set of useful tools to evaluate potential suppliers for product quality, as well as other important capabilities of suppliers. It’s not just a good idea, it’s the law, according to 21 CFR 820.50.

EU MDR: Extending the Transition Period for Medical Devices

The European Commission has implemented a proposal to extend the transitional period to certify medical devices under the Medical Devices Regulation (MDR). The proposal allows more time for manufacturers to transition from the previously applicable rules to the new requirements of the Regulation

Process Validation

All right, you have just gotten all of your paperwork together, submitted the right forms to the right people, set up your factory, hired and trained your staff; now it’s time to make the medical devices. The regulatory nonsense is over and done, right?

The Role of Management in Product Quality

Depending on the factory, some production employees may find it surprising that management has an important role to play in a quality system. 21 CFR 820.20 mandates that “Management with executive responsibility shall establish objectives for, and commitment to, quality”.[1] The Federal Government expects that management takes an active interest in improving the output of their company, at least in the case of medical device manufacturers.

EMMA International Consulting Group, Inc. and Thema Announce Strategic Partnership

EMMA International has entered into a strategic partnership with Thema, an Italian based strategic-regulatory consulting company. The goal of this strategic partnership is to expand geographical offerings to companies operating in the life sciences regulated space.

EMMA International’s Body of Knowledge (BOK)

Do you enjoy all the content from EMMA International? We have good news for you! EMMA International is proud to...

Medical Devices