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Category Archives: FDA Updates

27 Oct

FDA wants your comment!! – Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable

FDA announced an opportunity for public comment on the guidance document for informed consent for in vitro diagnostic device studies using leftover human specimens that are not individually identifiable. FDA regulations do not contain exceptions from the requirements of informed consent on the grounds that the specimens are not identifiable or that they are remnants

09 Oct

Incorporation of (UDIs) in Healthcare settings

On the same date, the Centers for Medicare and Medicaid Services (CMS) published a final rule that specifies the requirements that eligible providers and hospitals must meet to qualify for Electronic Health Record (EHR) incentive payments and solicits feedback about the Electronic Health Record (EHR) Incentive Programs going forward. Goal of this Activity: Incorporation of

30 Sep

The FDA new user fees for Fiscal Year 2016

The FDA new user fees for Fiscal Year 2016 (October 1, 2015 through September 30, 2016) are as follows: FY16 User Fees (in U.S. Dollars) Application Type Standard Fee Small Business Fee 510(k)‡ $5,228 $2,614 513(g) $3,529 $1,765 PMA, PDP, PMR, BLA $261,388 $65,347 panel-track supplement $196,041 $49,010 180-day supplement $39,208 $9,802 real-time supplement $18,297

22 Sep

CDRH Patient Engagement

Clients are being made aware of this new milestone development for the first time in the FDA’s history, through which FDA is establishing an advisory committee focused on patient engagement. The Patient Engagement Advisory Committee will provide advice on complex issues relating to medical devices, the regulation of devices, and their use by patients to

10 Sep

New FDA Regulations for the FOOD INDUSTRY – MAJOR CHANGES

Starting Sept 2016 All our food clients are made aware that the FDA has finally released the final rules on two regulations that will affect the human and animal foods. These changes will be the most comprehensive and dynamic changes to the Food Industry since the 1970’s. The intent is to provide new Safety Requirements

26 Aug

Revised FDA Fees for Issuing Export Certificates for Devices

NEWS FLASH!!! For those of those that ship FDA regulated devices out of the country we are familiar with export certificates. FDA has revised the payment requirements for export certificates, the fees are now: Original Certificates: $175 Subsequent Certificates issued for the same product(s): $85 The maximum number of pages for a certificate is now

06 Aug

New Revision – Refuse to Accept Policy for 510(k)’s

Clients are being made aware of an important development from the FDA with regards to the 510(k) submission process. A revised version of the guidance document “Refuse to Accept Policy for 510(k)’s” will go into effect October 1st, 2015. FDA revised this guidance with the purpose of describing the 510(k) Refuse to Accept (RTA) process

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

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