February 25, 2022 EU MDR
LinkedIn

2021 Warning Letters list from FDA for Med Devices

S.No Date Warning Description Manufacturer Product(s) Summary

1.

25-Jan-2021

CDRH advise manufacturer to “review websites, product labels, and other labeling and promotional materials to ensure that they are not misleadingly representing your products as safe and/or effective for a COVID-19-related use for which they have not been approved, cleared, or authorized by FDA and that you do not make claims that misbrand the products in violation of the Act.

Within 48 hours, please send an email to COVID-19-Task-Force-CDRH@fda.hhs.gov describing the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation.

Failure to adequately prevent address any violations may result in legal action, including, without limitation, seizure and injunction. . If you cannot take action to address this matter completely within 48 hours, state the reason for the delay and the time within which you will do so. If you believe that your product is not in violation of the Act, include your

EnMedMicroAnalytics Inc.

1.COVID-19 BLOOD SPOT COLLECTION PACKET
2. SARS-CoV-2 SALIVA RT-PCR TEST COLLECTION PACKET

The maker of Covid-19 Sample Collection Kits was selling the devices without FDA Clearance or approval. The agency advised EnMed to stop selling the Kits.

2.

02-Feb-2021.

FDA has reviewed your firm’s website www.spacetouch.com on February 2, 2021 and determined that the devices listed above are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. $351(f)(1)(B. The devices listed above are also misbranded under section 502(o) the Act, 21 U.S.C. $ 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. $360(k).

HAD has noted that some of these indications of treating serious life-threatening diseases, such as cancers, dysplasia, hyperbilirubinemiaand jaundice, osteoporosis, heart disease, kidney and digestive tract diseases, emaciation and anemia, etc., have not been verified with any clinical data in an FDA marketing application of this device type. These claims could mislead patients and result in the delay or substitution of critical medical treatment, thereby posing further health risks.

Marci Beauty LLC

1. light therapy devices
Jupiter
Vega
Neptune
Luna
Cosmo
Nova
Galaxa

The manufacturers have to take prompt action to address any violations described in this letter. Failure to adequately address this matter may lead to regulatory action being initiated by the FDA without further notice.

3.

26-Feb-2021

FDA has seen manufacturer’s Website and their claims on products, as per that they fit in the definition of the devices and has not taken approval or clearance of FDA for marketing, Violating the Regulations and so comes under adulterated and misbranded products.

CDRH advise manufacturer to “review websites, product labels, and other labeling and promotional materials to ensure that they are not misleadingly representing your products as safe and/or effective for a COVID-19-related use for which they have not been approved, cleared, or authorized by FDA and that you do not make claims that misbrand the products in violation of the Act.

Within 48 hours, please send an email to COVID-19-Task-Force-CDRH@fda.hhs.gov describing the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation.

Orvic(dbaWebstore-USA)

1.LUNGENE Covid-19at-home serology test

The manufacturer of the LUNGENE Covid-19 at-home serology test was selling the product without FDA clearance or approval. The agency advised the company to stop selling the test.

Click for more Warning Letter List

Browse by Topic