Regulatory Planning for FDA FY 2016

The FDA operates on a Federal Fiscal Year rather than a calendar year. The FY runs from October 1 through September 30. The new FY brings fee increases, expiration of registrations and statuses like the Small Business Decision, and a call for registration renewals. Regulatory Planning for FDA FY 2016 varies depending on if you are an existing company or a new company and whether you are a facility with food, dietary supplements, drugs, devices, or cosmetics. Below is an overview on regulatory planning for FDA FY 2016.

New Medical Device Companies

The FDA requires medical device facility registration within 30-days of entering the market. For facilities with Class I Exempt devices or just receiving their device approval (510(k), PMA, de novo) this time of year poses a challenge. Any registration occurring at this time is only valid until Sept. 30. From October 1 – December 31 the registration must be renewed. That means two filing fees within the span of a couple of months. Regulatory planning for FDA FY 2016 in this case may mean delaying market entrance until mid-September or registering now, but waiting until December to pay the renewal fee.

Many new device companies may have also applied for a Small Business Qualification Certification to reduce FDA filing fees. Small Business Determinations expire with the FY on September 30. If you have applied for a SBD or received a SBD number and not filed your pre-market application (510(k), 513(g), PMA etc.), then a second SBD application may be in order. Regulatory planning for FDA FY 2016 for a company in this scenario would involve assessing the time needed to complete the submission. There is no reason to rush a submission to claim FY 2015 SBD. Applying for FY 2016 SBD will involve the same steps and only add thee to four weeks to the time-frame.

Existing Drug and Device Companies

Regulatory planning for FDA FY 2016 is more mundane for existing drug and device companies with no planned submission. Those companies must renew their registrations with the FDA between Oct. 1 and Dec. 31. Drug companies should use this opportunity to list any new drug products added or revised formulations. Device companies will notice a small increase in the filing fee, now up to $3,872, but otherwise be unaffected by the countdown to the new FY.

Food and Dietary Supplement Companies

Regulatory planning for FDA FY 2016 is different for food and dietary supplement companies. All facilities registered with the Center for Food Safety and Applied Nutrition (CFSAN) are subject to a bi-annual registration based on the FDA fiscal year. New companies will need to register prior to entering the market, but renewals are not due this year. The last renewal period was between Oct. 1 – Dec. 31, 2014 and the next will be Oct. 1 – Dec. 31, 2016.

The above are a few of the ways the close of a federal fiscal year will impact regulatory planning. Be sure to consider registrations and submissions as the fiscal year winds down and the new fiscal year begins.

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Marc Sanchez

Marc Sanchez

Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.


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