Why has FDA inspected facilities that perform LASIK procedures?

  •  11/25/2020 05:52 AM

Inspection of ambulatory surgical facilities that perform LASIK procedures is one of the options available to FDA to ensure that physicians and patients have current and accurate information to help them with their decisions about LASIK. These inspections allow FDA to identify reporting problems and provide opportunities to further educate user facilities about MDR reporting obligations.

What are Medical Device Recalls?

  •  11/24/2020 12:46 AM

A recall means that the FDA and/or a manufacturer is aware of a problem with a device that could affect patient safety and health. Most manufacturers voluntarily recall medical devices that are found to have created health risks, but the FDA has the right under law to issue the recall if the company does not do so, or refuses to do so, which is rare. The recall may be related to a correction on a device or total removal of the device from the market.

What is the difference between NDA & ANDA?

  •  11/23/2020 01:04 AM

The New Drug Application (NDA) is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. In other words, when the sponsor of a new drug believes that enough evidence on the drug’s safety and effectiveness has been obtained to meet the FDA’s requirements for marketing approval

Can we use expired medical gloves? Do they offer the protection needed?

  •  11/18/2020 01:57 AM

Medical gloves were designed to serve as protective barriers and may still offer some protection even when they are used beyond the manufacturer’s designated shelf life or expiration date.

What Is Emergency Use Authorization (EUA)?

  •  11/17/2020 12:14 AM

EUA is a tool used by FDA to authorize the temporary use of products that fulfill urgent medical needs during public health emergencies. These products are authorized for use only in specific circumstances and expire once those conditions end.

What is an ambulatory surgical facility (ASF)?

  •  11/16/2020 02:31 AM

An ambulatory surgical facility is a distinct entity whose primary purpose is to furnish same day outpatient surgical services to patients. A facility that offers LASIK as one of its ophthalmic surgical procedures may also provide non-ophthalmic surgical services. Consider all surgical services provided by a facility when determining whether a facility meets the MDR definition of an ambulatory surgical facility and is therefore subject to the user facility obligations under MDR.

What is the difference between 510K and PMA?

  •  11/12/2020 07:18 AM

The purpose of a 510k submission is to provide the FDA with documented evidence which proves that your device is equivalent to a preceding device that has already been approved for marketing. The FDA processes 510k submissions in 30-90 days and if your application is accepted, your submission will be posted to the FDA 510(k) database. A Premarket Approval (PMA) is more in-depth than a 510k - it is used to prove that a new device is safe and effective for the end user and typically requires clinical trials with human participants along with laboratory testing. Under Section 515 of the act, all devices placed into Class III are subject to premarket approval requirements.

FDA Form 483 And Warning Letters: What's the Difference?

  •  11/11/2020 02:38 AM

A lot of pharmaceutical professionals have confusion between FDA Form 483 and Warning Letters. Both of these are issued by Food and Drug Administration (FDA) after a regulatory inspection of the manufacturing facility.

Does an IRB need to review custom use?

  •  11/4/2020 08:01 AM

FDA regulations do not require review and approval for custom device use. However, FDA recommends that as many of the patient protection measures listed in paragraph 16 be followed as possible.

What is the definition of a custom device?

  •  11/4/2020 07:56 AM

To be considered a custom device, the device must meet all of the following criteria, which are described in section 520(b) of the act and at 21 CFR 812.3(b)

What if the situation is not an emergency? Can a patient with a serious illness or condition have access to an investigational device outside a study?

  •  11/4/2020 07:35 AM

Yes, FDA recognizes that there are circumstances in which an investigational device is the only option available for a patient faced with a serious or life-threatening condition (hereinafter referred to as "compassionate use").

Must an IRB review a study conducted after submission of a (510(k)) to FDA but prior to FDA’s decision on that submission?

  •  11/4/2020 05:10 AM

Yes. During FDA’s review of the premarket notification submission, the device remains an investigational product.