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WHERE MEDICAL INNOVATIONS TAKE FLIGHT

FDA Finalizes 510(k) Guidances on When to Submit a New 510(k)

On October 25, 2017, the FDA released two final guidance documents: “Deciding When to Submit a 510(k) for a Change to an Existing Device,” which applies to medical device changes broadly, and “Deciding When to Submit a 510(k) for a Software Change to an Existing Device,” which focuses on software-specific changes and complements the broader guidance document.  These guidance documents supersede Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1), issued in 1997.

According to FDA, as medical device technology continues to evolve, these guidances are intended to provide recommendations to help manufacturers determine when an intended change to a legally marketed medical device subject to premarket notification (510(k)) requirements is significant enough to require FDA review, including changes that could significantly affect the safety or effectiveness of a device and major changes or modifications to a device’s intended use.

FDA stated that these final guidances build on the key concepts described in “Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1),” published January 10, 1997, with targeted changes to provide additional clarity on when a new 510(k) is needed.

FDA also emphasizes that the final guidance and its provisions are consistent with its “least burdensome approach” for 510(k)s, which states that FDA “shall only request information that is necessary [and] shall consider the least burdensome means of demonstrating substantial equivalence.”

Changes include:

  • Clarification of key terms
  • Explanation on how to use risk assessment to evaluate whether or not a change requires a new 510(k)
  • Harmonization of flowcharts with the text of the guidance
  • Examples of device changes that would or would not require a new 510(k), and
  • Recommendations for documenting decisions about whether or not to submit a new 510(k) for a device change

preclinical

FDA’s plan to engage the public in the agency’s new effort to strengthen and modernize FDA’s regulatory framework

On 07 September, 2017, FDA announced its plan to engage the public in the agency’s new effort to strengthen and modernize FDA’s regulatory framework.

FDA’s goal is to ensure that its policies and regulations keep pace with the challenges encountered in protecting consumers, and the opportunities to improve lives.

This new effort includes areas where FDA’s rules concerning new drugs are being used in ways that may create obstacles to the timely entry of generic competition. FDA stated that they wants to make sure their policies aren’t being misused in ways that thwart the competition that Congress intended when it created the modern generic drug framework. FDA reported that they are aware that vigorous generic competition can help benefit patients by lowering drug costs, which improves access to medicines. This is one example where FDA indicated that a closer analysis of their existing policies can help make sure FDA regulations are having their intended purpose.

FDA is also exploring ways to modernize regulations in a manner that will benefit all Americans. To achieve this, FDA is not only looking at what new regulations or policies they require in order to be most effective in fulfilling their public health responsibilities. FDA is also taking a closer look to see if they need to revise, update, and in some cases eliminate existing regulations to help them better keep pace with scientific advancement and the people that they serve. FDA stated that they need policies that are as modern as the products that they are being asked to evaluate, and a regulatory framework that uses efficient tools to achieve their vital consumer protection role.

FDA indicated that they need to take a risk-based approach in everything they do in order to make sure they are using their resources efficiently. FDA’s goal is to have regulations that reflect modern risks and opportunities, and use the full scope of FDA authorities to achieve their consumer protection mission.  Per FDA, this approach also aligns their efforts with the Administration-wide goal for federal regulatory reform to improve how government serves the American people.

Consequently, FDA is asking themselves and others to think about how current regulations could be reshaped to achieve their public health objectives through more efficient approaches. FDA is opening a number of public dockets to solicit feedback from patients, consumers, health providers, caregivers, industry, health groups, academia, as well as state, local and tribal governments, and public health partners.

Click link for access to the public dockets and more information on how to provide input on FDA’s regulations.

Strengthening EU-US cooperation in medicine inspections

New commitment allows FDA to share full inspection reports with European Commission and EMA

The European Commission (EC), the United States (US) Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have signed a new confidentiality commitment that allows the US regulator to share non-public and commercially confidential information, including trade secret information relating to medicine inspections with EU regulators. This confidentiality commitment is a milestone in the ongoing implementation of the mutual recognition of inspections of medicine manufacturers and it aims to strengthen the EU-US relationship. Ultimately it will contribute to a more efficient use of inspection resources by regulators for the protection of human and animal health.

See News Release  European Medicines Agency News 23 August 2017

 

preclinical

FDA Announces the Medical Device User Fee Rates for Fiscal Year 2018

On 29 August 2017, the Food and Drug Administration (FDA) announced the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2018.  The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV), authorizes FDA to collect user fees are for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration.

The fee rates for FY 2018, is effective from October 1, 2017, through September 30, 2018. To avoid delay in the review of the sponsor’s application, the sponsor should pay the application fee before or at the time they submit their application to FDA. The standard FDA registration fees for larger companies is increasing by 33%, with the 510(k) application fee rising 125%.  A comparison of the standard FY2017 MDUFA User Fees and FY2018 MDUFA User Fees is provided in below.

Application Type Standard Fee

FY2018 MDUFA

Standard Fee

FY2017 MDUFA

Percent Increase

(FY2017 MDUFA to FY2018 MDUFA)

510(k) $10,566 $4,690 125%
513(g) Request for Classification Information $4,195 $3,166 33%
PMA, PDP, PMR, BLA $310,764 $234,495 33%
panel-track supplement $233,073 $175,871 33%
180-day supplement $46,615 $35,174 33%
real-time supplement $21,753 $16,415 33%
BLA efficacy supplement $310,764 $234,495 33%
PMA annual report $10,877 $8,207 33%
30-day notice $4,972 $3,752 33%
De  Novo 93,229 N/A N/A

 

If a sponsor want to pay a reduced small business fee, the sponsor must qualify as a small business before making their submission to FDA; if the sponsor do not qualify as a small business before making their submission to FDA, they will have to pay the higher standard fee. The small business fees for most applications will see a 33% increases, with 13% increase for 510(k) user fees.  A comparison of the Small Business FY2017 MDUFA User Fees and FY2018 MDUFA User Fees is provided in below.

Application Type Small Business Fee

FY2018 MDUFA

Small Business Fee

FY2017 MDUFA

(FY2017 MDUFA to FY2018 MDUFA)
510(k) $2,642 $2,345 13%
513(g) Request for Classification Information $2,098 $1,583 33%
PMA, PDP, PMR, BLA $77,691 $58,624 33%
panel-track supplement $58,268 $43,968 33%
180-day supplement $11,654 $8,794 33%
real-time supplement $5,438 $4,104 33%
BLA efficacy supplement $77,691 $58,624 33%
PMA annual report $2,719 $2,052 33%
30-day notice $2,486 $1,876 33%
De novo Classification Request 23,307

 

Each establishment that is registered (or is required to register) with the Secretary of Health and Human Services under section 510 of the FD&C Act (21 U.S.C. 360) because such establishment is engaged in the manufacture, preparation, propagation, compounding, or processing of a device is required to pay the annual fee for establishment registration.  The FD&C Act specifies the base fee for establishment registration for each year from FY 2018 through FY 2022; the base fee for an establishment registration in FY 2018 is $4,375.  FDA Establishment Registration fees will rise 37% to $4,624 for the 2018 fiscal year from $3,382 in 2017. This fee is not discountable for small businesses.

Note: the establishment registration fee is not eligible for a reduced small business fee.   As a result, if the establishment registration fee is the only medical device user fee that a sponsor will pay in FY 2018, the sponsor should not submit a FY 2018 Small Business Qualification and Certification request.

See link for Federal Register notice: A Notice by the Food and Drug Administration on 08/29/2017