The FDA requires medical device manufacturers to incorporate electronic filing in their PMA, PreMarket Approval , or 510(K),  Premarket Notification, applications.

A PMA must be submitted in an electronic format (eCopy), with a signed, printed cover letter.  A PMA must be signed by the applicant or an authorized U.S. representative. If the applicant does not reside or have a place of business within the U.S., the PMA must be countersigned by an authorized representative who does.  The applicant must also provide the representative’s name and address.

Starting October 1, 2023, all 510(k) submissions, unless exempted, must be submitted as electronic submissions using eSTAR.

If you need any consultation, please call us at 949-885-8875.  We have more than a decade of experience in electronic applications for FDA and we had been submitting applications for  PMA and 510(K) over two decades.

This is an overview of Type II DMF and API.

Drug Master File (DMF) is used to provide confidential and detailed information about facilities, and processes used in the manufacturing, processing, packaging, and storing of one or more human drugs. A DMF is not a substitute for any Drug Application, or Export Application. It is not approved or disapproved. Technical content of a DMF submission is reviewed only in connection with the review of a Drug Application, or an Export Application. The DMF usually covers the Chemistry, Manufacturing and Controls (CMC) of a component of a drug product, for example, drug substance, excipient, packaging material. There are five types of DMFs: Among five different types of DMF’s, Type II is for Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product

Beginning May 5, 2018, the United States Food and Drug Administration (USFDA) mandated that the new DMFs as well as documentation for existing DMFs must be submitted using the Electronic Common Technical Document (eCTD). DMF submissions that are not submitted in eCTD format after this date will be rejected.

A DMF fee is only due and a Completeness Assessment performed if the material in the DMF is an API (Active Pharmaceutical Ingredient) and you intend for it to be referenced in a generic drug submission (i.e. ANDA).  If you need to pay the fee then you should get a pre-assigned DMF number and then submit all modules of the DMF when they are ready.  The pre-assigned number is sufficient to pay the fee but we would not be able to perform a Completeness Assessment until the entire DMF were submitted.

https://www.fda.gov/drugs/drug-master-files-dmfs/types-drug-master-files-dmfs

Please also check this link  Generic Drug User Fee Amendments (GDUFA) that includes provisions for DMF fees, a completeness assessment, and communications with DMF holders for Type II DMFs for drug substances (active pharmaceutical ingredients (APIs)) used to support ANDAs. These provisions do not apply to other types of DMFs or to Type II DMFs used to exclusively support NDAs or INDs. For more information about GDUFA as it relates to Type II DMFs, see:

• DMF enhancements under GDUFA II
• Completeness Assessments for Type II API DMFs Under GDUFA (guidance for industry)
  A completeness assessment is a series of questions that must be satisfied for a DMF to be made publicly available on FDA’s website. It does not replace the full scientific review to determine the adequacy of a DMF to support an ANDA regulatory action.
• List of Type II DMFs Available for Reference
  A list of DMFs that have passed the completeness assessment and are available for reference by ANDAs under GDUFA.
• Here is the updated List of DMF’s:   List of Drug Master Files (DMFs)

Acheve Technology, Inc. has been successfully submitted eCTD for DMF’s in the last five year and would like to help you to complete your eCTD submission of DMF’s.

For AI/ML medical application developers, 2019 is the best of the times and the worst of the times.

The best of the times are:

In April of this year, FDA released a proposal, Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML) – Based Software as a Medical Device (SaMD), which proposed a novel regulatory framework for AI-based medical devices. In about the same time, CMS(Center for Medicare & medicaid Services)announced a $1.65 million challenge to develop understandable AI products for healthcare.

The worst of the times are:

As hundreds of comments from manufacturers indicated, FDA’s proposal needed improvement and was in conflict with industry standards that were developed or being developed. Furthermore, some earlier approved computer aided diagnostics were deemed as failure in clinical publications.

And there are already over three hundred proposals were submitted to CMS in few weeks. The selected ones will get 1^st phase funding in October, 2019. This demonstrates the competition of AI/ML developers is really heating up.

In the last 30 years, I have provided regulatory submission of various class II and class III medical devices and Drug submission. Most were involved with innovative and ground breaking technologies. My experience of regulatory submission can be highlighted in the following four events:

• I led a multi-functional team with team members located in Netherland, Sweden and USA to obtain a PMA approval of an intraocular lens(a class III device) for Pharmacia(Sweden) in record time*. Pharmacia was merged with Pharmaceutical conglomerates Upjohn and Pfizer.
• I was invited by FDA as a guest speaker in a regulatory conference.
• I have obtained SBIR grant from NIH(National Institute of Health) based on one of my inventions.       (1 R43 EY020073-01)
• I converted dozens DMF’s(drug master files) to eCTD(electronic Common Technical Document ) format from original paper submissions and I also completed several new eCTD submissions with proprietary ESG set up that complies with FDA top down requirement.   The eCTD submissions were completed with ground up coding due to the unique features of the Drug Master File required by FDA and budget constraint of my clients.

If you are interested in my help in your regulatory service, please contact me via jsc@fdaconsultantnusagent.com or call us at 949 885 8875.

What is the Gateway?

The ESG is a portal that facilitates communication between the FDA and the pharmaceutical industry by providing a secure digital environment to submit regulatory documents for review, which operates on a similar principle to Fully-Verified’s KYC provider service.

The FDA Electronic Submissions Gateway is an Agency-wide solution for accepting electronic regulatory submissions and is the required method of transmission for eCTDs 10GB or less.

We are certified ESG Production provider.

Plan ahead for first-time submissions via the Gateway

Gaining access to the ESG is a multistep process that’s too important to rush. Based on our experience, we’d recommend setting up your account at least 2 months before the due date for your first electronic submission.

We specialize in eCTD submission, the new FDA registration paradigm.   We submit or update DMF and BPF.

Our ESG eCTD FDA Production was certified and validated by FDA.   If you have any question or concerns, please contact us at jsc@fdaconsultantnusagent.com

What is eCTD

The US Food and Drug Administration (FDA) is giving manufacturers an additional year before requiring master files to be submitted in electronic common technical document (eCTD) format.

In a revised guidance released in 2017, FDA says it is delaying the requirement for drug master files (DMF) and biological product files (BPF) to be submitted in eCTD format until 5 May 2018.

However, FDA is extending the date to comply with the requirement for master files to 5 May 2018 in response to concerns that some companies might not be able to meet the rapidly approaching deadlines.

“FDA has determined, in response to industry comments and internal review that there have been challenges with submission of master files in eCTD format, and eCTD uptake data for master files in particular indicated that adhering to the May 5, 2017 date could have led to high rejection rates of master files and thus slower FDA review processes,” FDA writes.

If you have any question or concerns, please contact us at jsc@fdaconsultantnusagent.com.  We specialize eCTD for DMF and BPF for either update or new submission.

Please note this date:

FDA sets date for eCTD schedule

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Today, the FDA issued a draft guidance document titled “Medical Devices Containing Materials Derived from Animal Sources” to help you identify the possible risks when animal sources are used in medical devices.

The Food and Drug Administration (FDA) is updating its policy regarding the use of animal-derived materials in medical device manufacturing to reduce the risk of transmitting infectious diseases. The guidance broadens the discussion of transmissible spongiform encephalopathies (TSEs) beyond the 1998 discussion of reducing exposure to bovine spongiform encephalopathy (BSE). This draft guidance is applicable to all manufacturers that produce medical devices that contain or are exposed to animal-derived materials (e.g., bovine, ovine, porcine, avian materials) with the exception of in vitro diagnostic devices.

The medical device industry will have an opportunity to submit comments and suggestions regarding the draft guidance within 90 days of publication in the Federal Register of the notice. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov.

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm381379.htm