Wilson Law Offices, PLLC
Free initial consultation
(304) 345-5508
Charleston, West Virginia, Personal Injury and Wrongful Death Attorney

Medical Malpractice Newsletter

FDA's Guidelines for Recalls

When a product is defective or harmful to the public, the Food and Drug Administration (FDA) may order or request a recall of the product from the market. Sometimes, the manufacturers of defective products will voluntarily recall the defective product, while other recalls are ordered by the FDA.

Can the FDA Order a Recall?

The FDA does not have the authority to “order” recalls. Instead, under the Federal Food, Drug, and Cosmetic Act, the FDA may “request” the recall of a harmful consumer product if the manufacturer is unwilling to recall the product without the FDA’s written request.

In April of 2008, the “Safe Food Enforcement, Assessment, Standards and Targeting Act of 2008” was proposed and immediately received the support of produce and food service industry leaders. The bill would enpower the FDA with the ability to initiate food recalls and would provide safety requirements to identify and prevent sources of foodborne illness.

FDA’s Guidelines Imposed on Companies for Product Recalls

Title 21 of the Code of Federal Regulations, Part 7 details the guidelines for companies to follow when recalling a harmful consumer product. Under these guidelines, companies are expected to:

  • Develop a recall plan in case there is a need for a recall
  • Notify the FDA of the recall and the starting date of the recall
  • Make progress reports to the FDA
  • Comply with the FDA’s request for a recall, if there is one
  • Undertake subsequent checks to make sure that the recall is successful

FDA’s Role and Duties in a Recall

The only instances where the FDA will order a recall are when the recall involves a medical device, human tissue products, or infant formula. Moreover, the FDA has the authority to determine the scope and extent of these recalls. Under the guidelines outlined in Title 21 of the Code of Federal Regulations, the FDA’s role is to:

  • Monitor the company recalls
  • Assess the company’s actions
  • Investigate the product for its defectiveness
  • Make sure the product is either destroyed or reconditioned

Types of FDA Recalls

There are three types of recalls. These classes are defined by the severity of the harm it may potentially cause the general public.

  • Class I – recalls dangerous or defective products that may cause serious health problems or even death
  • Class II – recalls less dangerous products than Class I, that may cause only temporary health problems
  • Class III – recalls products which may not cause severe health problems
  • Cerebral Palsy and Medical Malpractice
    Cerebral Palsy is a birth complication resulting from oxygen deprivation during pregnancy, labor or delivery that affects movement control and muscle condition. Cerebral Palsy occurs in approximately two to four babies out of every... Read more.
  • Should the ADA Stop Supporting the Use of Amalgams?
    Amalgams are a type of dental tooth filling which, unlike gold or porcelain fillings, contain mercury. In the past several years, the American Dental Association (ADA) and several state dental chapters have come under the attack of... Read more.
  • Burden of Proof and "Res Ipsa Loquitur" in Medical Malpractice Cases
    Medical malpractice lawsuits are usually based upon a claim that a health care provider was negligent. To establish negligence, the plaintiff must prove the practitioner’s actions fell below the accepted standard of care, i.e.,... Read more.
  • Undiagnosed Heart Disease and Malpractice
    Cardiological specialists are required to adhere to a strict standard of care in diagnosis and treatment. If a specialist deviates from the standard of care and, as a result, a cardiac patient suffers an injury, then the specialist must... Read more.
Medical Malpractice News Links
Share This Page:
Designed and Powered by NextClient

© 2015 - 2021 Wilson Law Offices, PLLC. All rights reserved.
Custom WebExpress™ attorney website design by NextClient.com.