TQMC has acquired wide Domain Knowledge and Experience. You can FREELY access it here and here

DISCLAIMER: This matter here is a guide only. For authentic and up-to-date information, please contact TQMC.

The DIRECTIVES and STANDARDS listed here may have been subsequently REVISED . You must refer to the CURRENT REVISION and AMENDMENTS if any.

Saturday, March 20, 2010

FDA Procedures on Product Recall

Recalls, Corrections and Removals (Devices)

Voluntary Recalls - 21 CFR 7
Mandatory Device Recalls - 21 CFR 810
Corrections and Removals - 21 CFR 806
Federal Register Notices


A recall is a method of removing or correcting products that are in violation of laws administered by the Food and Drug Administration (FDA). Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective. 21 CFR 7 provides guidance so that responsible firms may conduct an effective recall.

Medical device recalls are usually conducted voluntarily by the manufacturer under 21 CFR 7. In rare instances, where the manufacturer or importer fails to voluntarily recall a device that is a risk to health, FDA may issue a recall order to the manufacturer under21 CFR 810, Medical Device Recall Authority. 21 CFR 810 describes the procedures the FDA will follow in exercising its medical device recall authority under section 518(e) of the Federal Food, Drug, and Cosmetic Act (Act).

Under 21 CFR 806, Medical Device Correction and Removals, manufacturers and importers are required to make a report to FDA of any correction or removal of a medical device(s) if the correction or removal was initiated to reduce a risk to health posed by the device or to remedy a violation of the Act caused by the device which may present a risk to health.




  1. As mentioned, Bitcoins are generated by users through the official program.

    Profit margins are suffering in the meantime and there is a long list of companies battling rising costs of the commodities.
    Though pizzas are incredibly rich and exceptionally fattening Domino's has were able to maintain their nutritional value by using newly baked breads and vegetables and lean meats.

    Also visit my homepage: check this out

  2. With all due joys, this should be the period of utmost carefulness and conscious concentration on the vital issues affecting the future the nation
    and due attention of not being stabbed from the back.
    This means that your Egyptian cotton sheets will be
    much softer to sleep on than your ordinary cotton sheets.
    This is also probably one of the easiest forms of advertising,
    with only an advert designed for a specific box needing to
    be created. God gets all buddy-buddy with Satan and in fact hires Satan to cause
    our hero all sorts of misfortunes and calamities. This is standard cat behavior I'm probably preaching to the choir here.

    my web blog: egyptian newspapers

  3. They do not require as much work as many other animals do and are really fun to watch.
    E-papers are able to take advantage of story, sacrificing other, decidedly less important stories and giving as much detail about breaking news as possible.
    Hindi Samachar is entertaining millions of
    people with incredible reports, events, information and gossips.
    Some say it would have, because there is an ongoing collaboration between the two groups
    in attacks on Israel. I want them to be thrilled by the
    idea that each of us is capable of running into high adventure on every street corner and in
    every friendship.

    my homepage - click here

  4. With the ability to actually alter the texture and condition of the hair with clever and fashion-forward
    hair styling products, Rusk Being products are sure to intrigue
    the hair product lover in all of us. Likewise, using imported shampoos and
    conditioners from a tropical country when your climate is cold and temperate is not
    such a good idea. A well groomed woman will look to her hair and makeup first and a poll of 3,000 females across the
    UK revealed that about 44% feel attractive if they are having a good hair day, this compares to 16% who felt pleased with their appearance if good teeth gave them that winning

    Look at my web page :: hair products

  5. In the US, we still express this as cubic inches, feet, or yards.
    If a hairline crack in concrete has turned
    into a large crack, it will need to be cleaned out before the patching and repairing process.
    Flawless Flooring's polished concrete floor product boasts durability and decorative seamless surfaces made mainly from epoxy and polyurethane materials.