Software changes (windows 2007 compatible) notification to FDA?

sreenu927

Quite Involved in Discussions
#1
Dear All,

If there is a change in the software used in the medical device, then do we need to inform FDA?
This change is to make the instrument compatible to windows 2007.

The word, "notify" interms of FDA means what?
Is it to submit 510(k) supplement or new 510(k) or just a letter on company's letter head?

Thanks,
Sreenu
 
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M

maxenix

#2
Re: SW changes notification to FDA?

Dear All,

If there is a change in the software used in the medical device, then do we need to inform FDA?
This change is to make the instrument compatible to windows 2007.

The word, "notify" interms of FDA means what?
Is it to submit 510(k) supplement or new 510(k) or just a letter on company's letter head?

Thanks,
Sreenu
Guidance:"Deciding When to Submit a 510(k) for a Change to an Existing Device“ will help you, if this is a significant change, you need to submit a new 510(K), If not, only document the changes according to the GMP and update the device in the annual reports.
 
B

blewispunk

#3
You should also check out the two following guidances:
1. Guidance for Industry - Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software: Which states: "Is FDA premarket review required prior to implementation of a software patch to address a cybersecurity vulnerability? Usually not. In general, FDA review is necessary when a change or modification could significantly affect the safety or effectiveness of the medical device. 21 CFR 807.81(a)(3), 814.39."

2. Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices: Which states "For medical devices where the OTS Software represents a Minor Level of Concern, OTS Software changes would not typically require a new 510(k). However, the manufacturer is responsible for validating the change. For other medical devices, the decision as to whether a new 510(k) is required depends on the intended use of the device; the function of the OTS Software; and to what extent the risks due to OTS Software have been mitigated (see guidance on when to submit a 510(k)."

Additionally, you need to consider if this software change is being performed to reduce a risk to public health. If so, it may need to be reported to FDA as a Correction/Removal - click the link for more information on this.
 

bio_subbu

Super Moderator
#4
Dear All,

If there is a change in the software used in the medical device, then do we need to inform FDA?
This change is to make the instrument compatible to windows 2007.

The word, "notify" interms of FDA means what?
Is it to submit 510(k) supplement or new 510(k) or just a letter on company's letter head?

Thanks,
Sreenu
Hi Sreenu

If you want change the software used in the medical device, you may or may not have to submit a new 510(k) for the device. If the software change affects the safety, efficacy or intended use of the device, you need to submit a new 510(k). Please refer FDA Guidance document Deciding When to Submit a 510(k) for a Change to an Existing Device that will help you to decide whether you need to submit a new 510(k) or not.

If you do not need a new 510(k) for the change, you may wish to send a “Note to File” to the Office of Device Evaluations (ODE). Be sure to include the device’s K number on the document

Whether you submit a new 510(k) or not, but be sure to follow design controls for the software changes. Please keep copies of all data and records related to the software change in the device’s Design History File (DHF) and the device’s Device Master Record (DMR).

Please refer 21 CFR 1.101(4)(d) information about notification.

Sec. 1.101 Notification and recordkeeping

(d)Notification requirements for drugs, biological products, and devices exported under section 802 of the act. (1) Persons exporting a human drug, biological product, or device under section 802 of the act, other than a drug, biological product, or device for investigational use exported under section 802(c) of the act, or a drug, biological product, or device exported in anticipation of marketing authorization under section 802(d) of the act, shall provide written notification to FDA. The notification shall identify:

(i) The product's trade name;

(ii) If the product is a drug or biological product, the product's abbreviated or proper name or, if the product is a device, the type of device;

(iii) If the product is a drug or biological product, a description of the product's strength and dosage form or, if the product is a device, the product's model number; and

(iv) If the export is to a country not listed in section 802(b)(1) of the act, the country that is to receive the exported article. The notification may, but is not required to, identify countries listed in section 802(b)(1) of the act or state that the export is intended for a listed country without identifying the listed country.

(2) The notification shall be sent to the following addresses:

(i) For biological products and devices regulated by the Center for Biologics Evaluation and Research--Division of Case Management (HFM-610), Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. (Please verify the address has been changed)

(ii) For human drug products, biological products, and devices regulated by the Center for Drug Evaluation and Research--Division of New Drugs and Labeling Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002.

(iii) For devices--Division of Program Operations (HFZ-305), Center for Devices and Radiological Health, Food and Drug Administration, 2094 Gaither Rd., Rockville, MD 20850. (Please verify the address has been changed)

(e) Recordkeeping requirements for products subject to section 802(g) of the act. (1) Any person exporting a product under any provision of section 802 of the act shall maintain records of all drugs, biological products, and devices exported and the countries to which the products were exported. In addition to the requirements in paragraph (b) of this section, such records include, but are not limited to, the following:

(i) The product's trade name;

(ii) If the product is a drug or biological product, the product's abbreviated or proper name or, if the product is a device, the type of device;

(iii) If the product is a drug or biological product, a description of its strength and dosage form and the product's lot or control number or, if the product is a device, the product's model number;

(iv)The consignee's name and address; and

(v) The date on which the product was exported and the quantity of product exported.

(2) These records shall be kept at the site from which the products were exported or manufactured, and be maintained for the same period of time as required for records subject to good manufacturing practice or quality systems regulations applicable to the product. The records shall be made available to FDA, upon request, during an inspection for review and copying by FDA.

Regards
S.Subramaniam
 

sreenu927

Quite Involved in Discussions
#5
Dear Subbu Blewispunk and Maxenix,

Thank you for all your response and advice.

I suggested our team to file an internal memo, as this is not affecting the performance of the instrument.

Once again, thanks!

Regards
Sreenu
 
Q

QA_RA_Lady

#6
I assume that you are a sw manufacturer? If this is the case and you are just tring to qualify a new OS, then no... you don't need a new 510k for a new OS qualification. Provided you are adding no new functionality.

Update your SQA records (I make a seperate OS qualification file, i.e Windows qualifications with a tab for each version XP 32, XP64, XP 64 with SP1, Windows 7, etc.) within each tab I include a memo outlining 1) The devleopment efforts required for the change, 2) what test we will will run based on developement efforts 3) the test plans and results 4) An additional memo that I call the SVVR or test report doc that summarizes the results and ensures that outputs match inputs and the final decision of CCB or who ever you require signature from for design transfer.

Hope this helps.
 
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