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Category Archives: FDA Updates

13 Jul

Product code FLL – Clinical electronic thermometers now ruled from Class II 510(k) exempt to requiring a Class II 510(k) submission by the FDA

NEWS FLASH!!! The FDA has rethought their decision on re-classifying Clinical Electronic Thermometers to 510(k) exempt. mdi was part of the this process for the FDA to re-evaluate this decision. The FDA’s decision of making such an important clinical monitoring device to be marketed without FDA 510(k) clearance was “just not a good idea” and

29 Jun

Premarket Notification Requirements Concerning Gowns Intended for Use in Healthcare Settings

Gowns intended for use in healthcare settings must adequately provide a liquid barrier. This draft guidance provides FDA’s current thinking on the regulatory requirements and performance testing needed to support liquid barrier claims for gowns. Gowns can make two claims to barrier protection Minimal or Low Barrier protection:   a. ANSI/AAMI PB70 Level 1 protection

25 Jun

Unique Device Identification: Direct Marking of Devices – Draft Guidance

FDA released this draft guidance to provide its current thinking on direct marking of devices in regards to UDI requirements. For devices that are intended to be used more than once and reprocessed before each use, they must bear a UDI on the device itself if it is also are required to have a UDI

14 May

Electronic Submissions of New Drug, Biologic Files in Next Two Years

New FDA Update!!! Over the next two years FDA may require all new drug and biologic submissions to be sent electronically. FDA will adhere to the International Conference on Harmonization’s (ICH) electronic common technical document (eCTD) format. Adoption of this format will allow companies to submit an application for a new pharmaceutical or biological product

05 May

Personal Care Products Safety Act – Expanding FDA Authority over Cosmetics

On April 20th of this year two senators from Maine and California introduced the Personal Care Products Safety Act . If passed, this bill would expand FDA’s authority over cosmetic products sold in the United States. The changes are similar to that of requirements for nonprescription drugs including cosmetic GMP’s and ingredient review, establishment and

22 Apr

Clinical Trials Outside the United States

FDA draft guidance released There are many reasons why a sponsor may want to conduct a clinical trial Outside of the United States (OUS). Question is, will FDA accept this data to support marketing the device in the U.S.? Short answer, yes – provided certain conditions are met. For a PMA, under 21 CFR 814.15(b),

20 Apr

CDRH Electronic Submission for Home Use Device Labeling

PILOT PROGRAM FDA is accepting requests starting May 1st to May 31st 2015 for participation in their pilot program for electronic submission of home use device labeling. The labelling, including safety information and instructions for use, will be submitted through the registration and listing database. This database will be available to patients, caregivers, and the

15 Apr

New Expedited Access Program – PMA and De Novo

As part of the EAP program, FDA intends to provide more interactive communications during device development and more interactive review of Investigational Device Exemption applications, PMA applications, and requests for de novo review. This includes working with the sponsor to create a data development plan specific to the device, which would outline all data the

11 Apr

NDC/NHRIC Labeler codes for Medical Devices – FDA’s stand

We have been recently getting a lot of queries whether or not FDA can still issue NDC/NHRIC labeler codes for medical devices with the recent advent of the new UDI (Unique Device Identification) regulations being implemented by the FDA. The answer to this question is NO!!! Some of the clients are arguing about the NDC

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